How to Format References for Thesis & Research Paper Article

How to Format References for Thesis & Research Paper Article

Reference formatting  when you cite references in research article different publishers will follow the different guidelines according to their society rules. When writing a thesis for any piece of work you need to refer and your text material  produced by other people. This procedure is called citing or quoting references. References need to be cited in two different places.

How to Format References for Thesis & Research Paper Article

  1. At a point at which a document is referred to in the text of the work.
  2. In the list at the end of the work the bibliography other reference section

Let us discuss some general views on this.

Article Reference Formating

You put a superscript number after where you want to reference. I mean you can put a superscript number one after a statement.

You always need to put the reference after punctuation. For example if there is a comma and then the citation number.. If you have two citations for the same comment we put a comma between the two numbers separated by a space.

If you have more than two citations we put in the range of numbers separated by dash again after the punctuation point.

Author’s the journal title and then the author’s names the initials first separated by full stops and the last author is has the word and before him then you need to give the journal name appreciated appropriately and those abbreviations are available on the right side.

The year should be mentioned and insert a comma then give the volume in bold. Give issue number and then the first page number and then as a full stop.

Book Reference Formating

If its a Book reference you need to give the author’s names with and before the last author you’ve got the book title in italics. Then the publisher name. If there’s more than if this was more than the first edition we put in the Edition number. The publication site then the year of publication and all of that information is on the inside of a book cover.Book section reference and the page numbers at the end the rest of the format is the same so here we have the author who’s written a section in the book title we’ve got the book editors preceded by the words EDS heads had the publication year and strictly speaking this reference should also have the publication city and the publishers.

UGC Indexed Journals Approved Care List PDF

Here we present UNIVERSITY GRANTS COMMISSION approved and indexed Journals which are called UGC Care list. Pharmacy UGC Journals New Updated journals with high impact factor. The cost for these journals might be different some might be low cost and some can be at a higher end. 2020 2021. Pharmacy UGC approved journals need to be first verified before you contact them in the official website of University Grants Commission.  

UGC indexed journals – Approved List

  • Pharma Science UNIV Science Pharma Science Monitor
  • journal of Hospital and Clinical Pharmacy UNIV Science Wiley-Blackwell Publishing Ltd 22296921 India
  • Int J Ayu Pharm Chem (IJAPC) UNIV Science Green Tree Group
  • American Journal of Pharmacological Sciences UNIV Science Science and Education Publishing Co. Ltd 23276711 2327672 United States
  • Bulletin of Faculty of Pharmacy, Cairo University UNIV Science Faculty of Pharmacy, Cairo University 1110093 Egypt
  • Indo Global Journal of Pharmaceutical Sciences UNIV Science Rajeev K Singla, Ed.& Pub. 22491023 India
  • Pharmacophore An International Research Journal UNIV Science Jadoun Science Publishing Group 22295402 India
  • International journal of Medicinal Chemistry UNIV Science Hindawi 20902069 20902077 India
  • Tuberculosis Research and Treatment UNIV Science Hindawi, US 2090150x Egypt 44575
  • Open Pharmaceutical Sciences Journal UNIV Science Bentham Open 18748449 U.A.E
  • Journal of Pharmacognosy &Phytochemistry UNIV Science Society of Pharmacognosy and
  • Phytochemistry 23498234 22784136 India
  • Functional Foods in Health and Disease UNIV Science Functional Food Center, Inc. 21603855 United States
  • UNIVERSITY GRANTS COMMISSION approved and indexed Journals pdf
  • Current Pharma Research UNIV Science Unicorn Publications, India 22307842 India Inventi Rapid Molecular Pharmacology
  • Journal of Drug Delivery and Therapeutics UNIV Multidisciplinary Society of Pharmaceutical Technocrats 22501177 IndiaUNIV Science Inventi Journals Pvt. Ltd 22294171 09763856 India
  • Journal of New Results in Science UNIV Science Gaziosmanpasa University 13047981 Turkey
  • Pharmaceutical Nanotechnology UNIV Science Bentham Science Publishers Ltd 22117393 U.A.E
  • The Pharma Innovation Journal UNIV Science AkiNik Publications,AkiNik Publications India
  • International Journal of Pharmacy and Biological Sciences UNIV Science Jayapal Reddy Gangadi, Ed. & Pub. 22307605 India
  • journal of Pharmasceutical and scientific innovation UNIV Science Moksha Publication 22774572 India
  • Research Journal of Life Sciences, Bioinformatics, Pharmaceutical and Chemical Sciences (RJLBPCS)UNIV Science Jaysingpur India
  • International Research Journal of Humanities, Engineering & Pharmaceutical Sciences, UNIV Social Science Gayatri Publications India
  • Journal of Pharmaceutical ,Chemical and Biological Sciences UNIV Science : www.jpcbs.info India
  • Asian Journal of Pharmaceutical Biochemical Research UNIV Science Dr Bharat Parashar 22312560 India
  • International Journal of Pharmaceutical and Biological UNIV Science Mandsaur Institute of Pharmacy 09763333 India
  • Pharmaceutical Methods UNIV Science Phcog.Net India
  • International Journal of Pharmaceutical investigation UNIV Science Medknow Publication and media pvt. Ltd 2230973 India
  • Asian Journal of Pharmacy and Pharmacology UNIV Science Pharmaceutical research information group 24552674 India
  • International journal of Pharmaceutical Research UNIV Science Association of Indian Pharmacist 09752366 India
  • Medicines, Ethics and Practice UGC Science Royal Pharmaceutical Society United Kingdom
  • International Journal of Bio Pharma Research UNIV Science International journal of biopharma and research 22876898 India
  • Future journal of pharmaceutical sciences UNIV Science Elsevier 23147245 United Kingdom
  • Journal Biosciences and Technology UNIV Science Pharma Info Publications 09760172 India
  • International Journal Pharmacology, phytochemistry and ethnomedicine UNIV Science Scipress 22976922 22976922 Switzerla
  • Asian Journal of Research in Chemistry and Pharmaceutical Sciences UNIV Science Uptodate Research Publications, India 23497106 India

UNIVERSITY GRANTS COMMISSION approved and indexed Journals pdf

UGC care list of journals pdf will be provided here soon. Updated journals list 2020 to publish Pharmaceutics, Pharmacology, Pharmacognosy, Pharmaceutical analysis, Pharmaceutical chemistry.

B.PHARMACY & M. PHARMACY PROJECTS: TOPICS FOR PROJECT WORK OF Pharmacognosy STUDENTS

B.PHARMACY & M. PHARMACY PROJECTS TOPICS FOR PROJECT WORK OF Pharmacognosy STUDENTS

Pharmacognosy B.PHARMACY & M. PHARMACY PROJECTS TOPICS

Effect of Natural Product Clove Bud Oil on Pathogenic Pseudomonas aeruginosa Virulence and Host Response

Phytochemical And Anti-Inflammatory Studies On The Hexane Extract Of The Stem Bark Of Steganotaenia Araliacea Hoschts (Apiaceae)

Phytochemical And Inhibition Studies Of Garcinia Kola Heckel (Guttiferae) Seed Extracts On Some Key Enzymes Involved With Diabetes

Phytochemical And Biological Studies On The Seeds Of Jatropha Curcas Linn. (Euphorbiaceae) –

Phytochemical And Anti Bacterial Studies On The Stem Bark Of Lannea Barteri. (Oliv.) Engl. (Anacardiaceae)

Pharmacognostic And Pro-Fertility Evaluations Of Dracaena Arborea (Willd) Linn. (Dracaenaceae) –

Pharmacognostic And Antimicrobial Studies On The Stem-Bark Of Ficus Kamerunensis Warb. (Moraceae)

Pharmacognostic And Antibacterial Studies Of The Leaf Extracts Of Swartzia Madagascariensis Desv (Fabaceae)

Pharmacognosy  M. PHARMACY PROJECT TOPICS

Pharmacognostic And Antibacterial Studies Of Acacia Sieberiana Var Woodii (Fabaceae) Stem Bark –

Antimicrobial Property Of The Hexane Extract From The Pods Of Acacia Nilotica(L.) Del.

Phytochemical And Antimalarial Studies Of The Leaves Of Uvaria Chamae P.Beauv. (Annonaceae) –

Development And Validation Of Spectrophotometric Methods For The Determination Of Risperidone In Pure And Tablet Dosage Forms

Spectrophotometric Determination And Stability Studies Of Artemether In Artemether-Lumefantrine Suspensions Marketed In our Country, Nigeria

Phytochemical Studies And Effect Of Methanol Leaf Extract Of Leptadenia Hastata (Pers.) Decne (Asclepiadaceae) On Acetic Acid Induced Writhes In Mice And Venom Of Echis Ocellatus –

Phytochemical And Antimicrobial Studies On The Stem-Bark Of Commiphora Mollis (Oliv. ) Engl. (Burseracaea)

Phytochemical And Antimicrobial Studies Of Spermacoce Verticillata (Rubiaceae)

Comparative Evaluation Of The Ascorbic Acid Content Of Mineral Ascorbate And Ascorbic Acid Tablets Marketed In our Country

Pharmacognosy B.PHARMACY PROJECT TOPICS

Extraction, Formulation and Pharmacological evaluation of an Anti Microbial Cream Alexeyena Varghese

Pregnancy complications and role of life style modifications in a woman with Poly Cystic Ovary Syndrome (Pcos) Remya Reghu

Development and Validation of quantitative methods for the estimation of a drug in a dosage form Aneesh T. P.

Design, Synthesis and biological evaluation of Indole-3-Carbinol Sathianarayanan S.

Phytochemical, Pharmacological analysis and formulative study of aqueous extracts of dried galls of Quercus Infectoria Deepa T. Vasudevan

Study for assessment of knowledge , compliance and behavior of diabetes patients Meenu Vijayan

Preparation and evaluation of extended Release tablets Vidya Viswanad

Development and evaluationof Gastro- Retentive Floating Tablet(GRFT) of Rantidine Hydrochloride Swati Gupta

Role of Pharmacists in communication gap between Physician and Patient Leena Thomas

Study of dental problems in diabetic patients and their therapeutic management Naveen Kumar Panicker

Spasmolytic effect of (-) carvone on Isolated Vascular and Non-Vascular superfused smooth muscle preparations Mohamed Shabi

B.PHARMACY & M. PHARMACY PROJECTS TOPICS FOR PROJECT WORK OF Pharmacognosy STUDENTS

Human RBC Membrane stabilization study using Anti – inflammatory drug by In-vitro method Jipnomon Joseph

Evaluation of Antimicrobial Activity of Aqueous Leaf Extracts of Chrysophyllum cainito R. Aravind

Study on complication of Gestational Diabetes and its management in a tertiary care teaching hospital Roshni P. R.

Comparative study of different species of Tulasi for larvicidal activity Rahul R.

Formulation, evaluation and In-Vitro activity of Gel loaded with Quinex Moringa Litha Thomas

Anti oxidant Activity of chromene compounds and their microwave synthesis

B.PHARMACY & M. PHARMACY PROJECTS: TOPICS FOR PROJECT WORK OF Pharmaceutical Chemistry STUDENTS

B.PHARMACY M. PHARMACY PROJECTS TOPICS FOR PROJECT WORK OF Pharmaceutical Chemistry STUDENTS. pdf

Here are B.PHARMACY & M. PHARMACY PROJECTS: TOPICS FOR PROJECT WORK OF Pharmaceutical Chemistry STUDENTS. Medicinal Chemistry is a vast and pious branch in Pharmaceutical sciences. Many researchers and professors are into huge research. Drug Discovery is the trending research in Pharmaceutical chemistry branch of Medicinal Chemistry. Drug Design, synthesis and binding studies  of different products along with traditional synthesis of products is current research era. Trying different and Innovative ways to drug discovery through receptors peptides Enzymes Harmon’s is one good thought for selecting some project in your B.PHARMACY & M. PHARMACY PROJECTS.

Pharmaceutical Chemistry Projects for M Pharmacy B Pharmacy

Design, synthesis and binding studies of water-soluble fluoride receptors

Developing an enzymatic toolbox to make complex modified peptides

Discovery of novel pharmaceuticals from marine and desert microorganisms

Synthesis and study of simplified vancomycin analogues as novel antibiotics

Organic crystals with large channels and nanopores

Innovative ways to disinfect surfaces using catalysis

Discovery of novel cancer immunotherapeutic agents

First-Principles Based Mechanochemistry of Pharmaceutical Active Ingredients

Molecular mechanism of action and inhibition of ATP synthase using biomolecular simulations

Carbon nanotubes in the boron neutron capture therapy of cancer

In silico modelling of protein dynamics in heart disease

Targeting the CXCR4-CB2 G-protein coupled receptor complex as a treatment for breast cancer

Shape Variant Nanoparticles for Pathogen Sensing

Magnetic hyperthemia for cancer treatment: synthesis, biofunctionalisation of nanoparticles for thermo-chemotherapy

Total Synthesis of the Dineolignan Ophiocerol and Derivatives

Synthesis of bioactive natural products and associated analogues

Chiral sulfoxide auxiliaries for the asymmetric synthesis of benzannulated spiroketals

Synthesis of unusual dispiro metabolites

Synthesis of danshenspiroketallactones and cryptoacetalides

Synthesis of Danshenspiroketallactone and Cryptoacetalide for the Treatment of Cardiovascular Disorders

Vaccine design for lectin targets

Organocatalytic assymetric synthesis of 6,5-benzannulated spiroketals

Synthetic and Computational Studies on Members of the Pyranonaphthoquinone Family of Anitbiotics

Design and synthesis of rat selective toxicants

Investigating the efficacy of novel antimicrobial mixes on microorganisms, surfaces and cells lines; an integrated study

Natural products as prophylaxis and treatment for gonococcal eye infections

Novel assays for screening drug – lipid membrane interactions

Organic/physical/computational chemistry – Improved methods for modelling reactivity and physical properties

Design and Synthesis of a Prospective Drug Candidate Against Diabetes

Synthesis of Mukanadin B and Analogues as Possible Neuroprotective Agents

B.PHARMACY PROJECTS TOPICS

  • Anti Inflammatory Activity of Chalcones
  • Design, Synthesis & Biological Evaluation of Antiprostrate Cancer Agents
  • Studies on the constituents isolated from the Shizoines of Nervilia Aragoana GAUD
  • Studies on effect of Structural modifications on Antimicrobial Chitoran
  • In silico design,Synthesis and Invitrostudies of some novel 4H-Chromene Derivatives as Anticancer Agents
  • Structural model of the Alpha-pPhosphoglucomutase and De Novo design of Inhibitors for the treatment of Mycobacterium Tuberculosis

Aza-lignan project in Medicinal Chemistry

Derivatives of Anticancer Agents

 M. PHARMACY PROJECTS TOPICS – Pharmaceutical Chemistry

Synthesis of Biologically Active Lignan Natural Products via an Acyl-Claisen Rearrangement and an Unusual 1,4-diaryl Rearrangement

Studies towards the asymmetric synthesis of 1,4-benzodioxane neolignans

Development of bioactive 3C protease inhibitors as therapeutics to treat the common cold

Novel Selective Ligands of the CB1/D2 Receptor Heterodimer

Method Development for Characterization of Novel Copper Chelators in Patients with Diabetes

Synthetic investigation of neurologically active therapeutic agents

Synthesis of cyclic peptides isolated from a psychrophile

Total Synthesis of Aspergillus Spiroketal and its analogues

Asymmetric gold-catalysed synthesis of the paecilospirone spiroacetal

Total synthesis of lasionectrin and related analogues as novel anti-malaria agents

Synthesis of marine derived natural products Aigialospirol and its analogues

B.PHARMACY M. PHARMACY PROJECTS TOPICS FOR PROJECT WORK OF Pharmaceutical Chemistry STUDENTS. pdf

Total synthesis of terreinol, a spiroketal natural product, and investigation into enantioselective oxidative spiroketalisation

Studies towards onchidal’s acetycholine esterase inhibitory activity

The synthesis and investigation of marine natural products as potential anti-fouling agents

Bioactive marine natural product

The synthesis of natural product containing polymers for use in the prevention of biofilms

Marine Natural Products in Drug Discovery

Studies Towards the Design, Synthesis and Analysis of Bioactive Peptides

Studies towards the identification and synthesis of proteins expressed in intact and degenerate bovine cartilage

Peptide conjugation to build tumour selectivity into potential chemotherapeutic agents

Medicinal Chemistry Projects or Pharma Chemistry Projects for Masters / B Pharmacy

In Medicinal chemistry Projects B pharmacy and M Pharmacy students can take up wide variety of research topics which deals with Synthesis, Characterization and Docking Studies of some products, or Green Synthesis and Characterization of products, or In Silco Molecular Modeling or Cellular Redox State Modifications or High Throughput Kinetic Assay for Screening Potential Inhibitors. You can also try Method Development for Characterization of Novel products. Just you can make a list of your interested research topics for your B pharm and M Pharm projects and give them to your Guide. He or she will mentor you according to the current trend, necessity and resources availability.

Below are few examples of projects for pharmacy students who are interested in Medicinal Chemistry. These are the current trending and ongoing project list from different places and institutes.

  1. Synthesis of Mukanadin B and Analogues as Possible Neuroprotective Agents
  2. Synthesizing novel self assembled monolayer conductive polymers for improving biocompatible and norotrophic devices
  3. Synthesis of Biologically Active Lignan Natural Products via an Acyl-Claisen Rearrangement and an Unusual 1,4-diaryl Rearrangement
  4. Studies towards the asymmetric synthesis of 1,4-benzodioxane neolignans
  5. Total Synthesis of the Dineolignan Ophiocerol and Derivatives
  6. Synthesis of bioactive natural products and associated analogues
  7. Vaccine design for lectin targets
  8. Design and synthesis of rat selective toxicants
  9. Development of bioactive 3C protease inhibitors as therapeutics to treat the common cold
  10. Novel Selective Ligands of the CB1/D2 Receptor Heterodimer
  11. Method Development for Characterization of Novel Copper Chelators in Patients with Diabetes
  12. Synthetic investigation of neurologically active therapeutic agents
  13. Synthesis of cyclic peptides isolated from a psychrophile\
  14. Total Synthesis of Aspergillus Spiroketal and its analogues
  15. Asymmetric gold-catalysed synthesis of the paecilospirone spiroacetal \
  16. Total synthesis of lasionectrin and related analogues as novel anti-malaria agents
  17. Synthesis of marine derived natural products Aigialospirol and its analogues
  18. Total synthesis of terreinol, a spiroketal natural product, and investigation into
  19. enantioselective oxidative spiroketalisation
  20. Studies towards onchidal’s acetycholine esterase inhibitory activit
  21. Design and synthesis of rat selective toxicants
  22. Development of bioactive 3C protease inhibitors as therapeutics to treat the common cold
  23. Novel Selective Ligands of the CB1/D2 Receptor Heterodimer
  24. Method Development for Characterization of Novel Copper Chelators in Patients with Diabetes
  25. Synthetic investigation of neurologically active therapeutic agents
  26. Synthesis of cyclic peptides isolated from a psychrophile
  27. Total Synthesis of Aspergillus Spiroketal and its analogues
  28. Asymmetric gold-catalysed synthesis of the paecilospirone spiroacetal
  29. Total synthesis of lasionectrin and related analogues as novel anti-malaria agents
  30. Synthesis of marine derived natural products Aigialospirol and its analogues
  31. Total synthesis of terreinol, a spiroketal natural product, and investigation into enantioselective oxidative spiroketalisation
  32. Studies towards onchidal’s acetycholine esterase inhibitory activity.

Homology Modelling of Protein Steps Tools Software Tutorial PDF PPT Papers

Homology Modelling of Protein Steps Tools Software Tutorial PDF PPT Papers

What is Homology Modelling?

Homology modelling allows users to safely use rapidly generated in silico protein models in all the contexts where today only experimental structures provide a solid basis: structure-based drug design, analysis of protein function, interactions, antigenic behavior, and rational design of proteins with increased stability or novel functions. In addition, protein modeling is the only way to obtain structural information if experimental techniques fail. Many proteins are simply too large for NMR analysis and cannot be crystallized for X-ray diffraction.

Homology Modelling of Protein Steps Tools Software Tutorial PDF PPT Papers

Among the major approaches to three-dimensional (3D) structure prediction, homology modeling is the easiest one.
In the Homology Modelling, structure of a protein is uniquely determined by its amino acid sequence (Epstain, Goldberger, and Anfinsen, 1963). Knowing the sequence should, at least in theory, suffice to obtain the structure.
2. During evolution, the structure is more stable and changes much slower than the associated sequence, so that similar sequences adopt practically identical structures, and distantly related sequences still fold into similar structures. This relationship was first identified by Chothia and Lesk (1986) and later quantified by Sander and Schneider (1991). Thanks to the exponential growth of the Protein Data Bank (PDB), Rost (1999) could recently derive a precise limit for this rule. As long as the length of two sequences and the percentage of identical residues fall in the region marked as “safe,” the two sequences are practically guaranteed to adopt a similar structure.

Homology Modelling or Protein Modelling Example

Imagine that we want to know the structure of sequence A (150 amino acids long,). We compare sequence A to all the sequences of known structures stored in the PDB (using, for example, BLAST), and luckily find a sequence B (300 amino acids long) containing a region of 150 amino acids that match sequence A with 50% identical residues. As this match (alignment) clearly falls in the safe zone (Fig. 25.1), we can simply take the known structure of sequence B
(the template), cut out the fragment corresponding to the aligned region, mutate those amino acids that differ between sequences A and B, and finally arrive at our model for structure A. Structure A is called the target and is of course not known at the time of modeling.

Homology Modelling of Protein Steps Tools Software Tutorial PDF PPT

Homology Modelling Steps

In practice, homology modeling is a multistep process that can be summarized in seven steps:
1. Template recognition and initial alignment
2. Alignment correction
3. Backbone generation
4. Loop modeling
5. Side-chain modeling
6. Model optimization
7. Model validation

At almost all the steps choices have to be made. The modeler can never be sure to make the best ones, and thus a large part of the modeling process consists of serious thought about how to gamble between multiple seemingly similar choices. A lot of research has been spent on teaching the computer how to make these decisions, so that homology models can be built fully automatically. Currently, this allows modelers to construct models for about 25% of the amino acids in a genome, thereby supplementing the efforts of structural genomics projects.

Homology_Modelling – Protein PPT

homology modeling

Protein Homology modelling steps ppt Structures

Homology Modelling Steps, Homology Modelling Software, Homology Modelling Ppt, Homology Modelling Pdf, Homology Modeling Server, Protein Modelling Bioinformatics, Homology Modeling Tutorial, Homology Modelling Slideshare

Pharmaceutical Water Systems: Pharmaceutical Water Storage & Distribution Systems [PDF PPT]

Pharmaceutical Water Systems Pharmaceutical Water Storage & Distribution Systems [PDF PPT]

Water storage and distribution systems

Pharmaceutical Water Systems:: Water storage and distribution systems applies to WPU systems for PW, BHPW and BWFI. The water storage and distribution should work in conjunction with the purification plant to ensure delivery of water of consistent quality to the user points, and to ensure optimum operation of the water purification equipment.

General Principles of Water storage and distribution systems of Pharmaceutical Water Systems:

  1. The storage and distribution system should be considered as a key part of the whole system and should be designed to be fully integrated with the water purification components of the system.
  2. Once water has been purified using an appropriate method it can either be used directly or, more frequently, it will be fed into a storage vessel for subsequent distribution to points of use. The the requirements for storage and distribution systems and point of use fflPOU) is provided below.
  3. The storage and distribution system should be configured to prevent microbial proliferation and recontamination of the water fflPW, BHPW, BWFI) treatment. It should be subjected to a combination of online and offline monitoring to ensure that the appropriate water specification is maintained.

2 Materials that come into contact with systems for water for pharmaceutical use in Pharmaceutical Water Systems:

Here we deal with generation equipment for PW, BHPW and BWFI and the associated storage and distribution systems.

2.2 The materials that come into contact with WPU, including pipework, valves and fittings, seals, diaphragms and instruments, should be selected to satisfy the following objectives.

Compatibility.

The compatibility and suitability of the materials should encompass the full range of its working temperature and

potential chemicals that will come into contact with the system at rest, in operation and during sanitization.

Prevention of leaching.

All materials that come into contact with WPU should be non-leaching at the range of working and sanitization

temperatures of the system.

Corrosion resistance.

PW, BHPW and BWFI are highly corrosive. To prevent failure of the system and contamination of the water, the materials selected must be appropriate, the method of jointing must be carefully controlled and all fittings and components must be compatible with the pipework used. Appropriate sanitary specification plastics and stainless-steel materials are acceptable for WPU systems. When stainless steel is used it should be at least grade 316. In general 316L or a higher grade of stainless steel is used. The system should be passivated after initial installation or after significant modification. When accelerated passivation is undertaken the system should be thoroughly cleaned first and the passivation process should be undertaken in accordance with a clearly defined documented procedure.

Smooth internal Finish.

Once water has been purified it is susceptible to microbiological contamination and the system is subject to the formation of biofilms when cold storage and distribution are employed. Smooth internal surfaces help to avoid roughness and crevices within the WPU system. Crevices can be the source of contamination because of possible accumulation of microorganisms and formation of biofilms. Crevices are also frequently sites where corrosion can commence. The internal material finish should have an arithmetical average surface roughness of not greater than 0.8 micrometre fflRa). When stainless steel is used, mechanical and electro-polishing techniques may be employed. Electro-polishing improves the resistance of the stainless-steel material to surface corrosion.

Jointing.

The selected system materials should be easily joined by welding in a controlled manner. The control of the process should include, as a minimum, qualification of the operator, documentation  of the welder set-up, work session test pieces logs of all welds and visual inspection of a defined proportion of welds, e.g. 100ft hand welds, 10ft automatic welds.

Documentation.

All system components should be fully documented and be supported by original or certified copies of material certificates.

Materials used for Pharmaceutical Water Systems:

Suitable materials that may be considered for sanitary elements of the system include 316L ffllow carbon) stainless steel, polypropylene, polyvinylidene-diFluoride and perFluoroalkoxy. The choice of material should take into account the intended sanitization method. Other materials such as unplasticized polyvinyl-chloride ffluPVC) may be used for treatment equipment designed for less pure water such as ion exchangers and softeners.

None of the materials that come into contact with WPU should contain chemicals that will be extracted by the water. Plastics should be non-toxic and should be compatible with all chemicals used. They should be manufactured from materials that should at least meet minimum food grade standards. Their chemical and biological characteristics should meet any relevant pharmacopoeia specifications or recommendations. Precautions should be taken to define operational limits for areas where water circulation is reduced and turbulent Flow cannot be achieved. Minimum Flow rate and change volumes should be defined.

3. System sanitization and bioburden control -Pharmaceutical Water Systems:

1 Water treatment equipment, storage and distribution systems used for BPW, BHPW and BWFI should be provided with features to control the proliferation of microbiological organisms during normal use, as well as techniques for sanitizing the system after intervention for maintenance or modification. The techniques employed should be considered during the design of the system and should take into account the interdependency between the materials and the sanitization techniques.

2 Systems that operate and are maintained at elevated temperatures ffle.g. > 65) are generally less susceptible to microbiological contamination than systems that are maintained at lower temperatures. When lower temperatures are required due to the water treatment processes employed or the temperature requirements for the water in use, special precautions should be taken to prevent the ingress and proliferation of microbiological contaminants fflsee section 6.4.3 for guidance).

4 Storage vessel requirements -Pharmaceutical Water Systems:

1 General

1 The water storage vessel used in a system serves a number of important functions. The design and size of the vessel should take into consideration the following.

2 Capacity

1 The capacity of the storage vessel should be determined on the basis of the following requirements:

It is necessary to provide a buffer capacity between the steady-state generation rate of the water-treatment equipment and the potentially variable simultaneous demand from user points.

The water-treatment equipment should be able to operate continuously for significant periods to avoid the equipment stress that occur when the equipment cycles on and off too frequently.

The capacity should be suffcient to provide short-term reserve capacity in the event of failure of the water-treatment equipment or inability to produce water due to a sanitization or regeneration cycle. When determining the size of such reserve capacity, consideration should be given to providing suffcient water to complete a process batch, work session, tank turnover by recirculation to minimize stagnation, or other logical period of demand.

3 Contamination control considerations -Pharmaceutical Water Systems:

The following should be taken into account for the efficient control of contamination:

) The headspace in the storage vessel is an area of risk where water droplets and air can come into contact at temperatures that encourage the proliferation of microbiological organisms. The use of spray-ball or distributor devices should be considered in these systems to wet the surfaces during normal operation, chemical and/or thermal sanitization.

) Nozzles within the storage vessels should be configured to avoid dead zones where microbiological contamination might be harboured.

) Vent filters are fitted to storage vessels to allow the internal level of liquid to Fluctuate. The filters should be bacteria-retentive, hydrophobic and should ideally be configured to allow in situ testing of integrity. Offline testing is also acceptable. The use of heated vent filters should be considered for continuous hot storage or systems using periodic heat sanitization to prevent condensation within the filter matrix that might lead to filter blockage and to microbial growth that could contaminate the storage vessels.

) Where pressure-relief valves and bursting discs are provided on storage vessels to protect them from under- and over-pressurization, these devices should be of a sanitary design. Bursting discs should be provided with external rupture indicators to ensure that loss of system integrity is detected.

Requirements for water distribution pipework -Pharmaceutical Water Systems:

General

The distribution of BPW, BHPW and BWFI should be accomplished using  a continuously circulating pipework loop. Proliferation of contaminants within the storage tank and distribution loop should be controlled. Good justification for using a non-recirculating one-way system should be provided.

2 Filtration should not usually be used in distribution loops or at take off-user points to control biocontamination. Such filters are likely to conceal system contamination.

Temperature control and heat exchangers

Where heat exchangers are employed to heat or cool WPU within a system, precautions should be taken to prevent the heating or cooling utility from contaminating the water. The more secure types of heat exchangers of the double tube plate or double plate and frame or tube and shell configuration should be considered. Where these types are not used, an alternative approach whereby the utility is maintained and monitored at a lower pressure than the WPU may be considered. The latter approach is not usually adopted in BWFI systems.

Where heat exchangers are used they should be arranged in continually circulating loops or subloops of the system to avoid unacceptable static water in systems.

When the temperature is reduced for processing purposes the reduction should occur for the minimum necessary time. The cooling cycles and their duration should be proven satisfactory during the qualification of the system.

Pharmaceutical Water Systems Pharmaceutical Water Storage & Distribution Systems [PDF PPT]

3 Circulation pumps

Circulation pumps should be of a sanitary design with appropriate seals that prevent contamination of the system. Where stand-by pumps are provided, they should be configured or managed to avoid dead zones trapped within the system.

Consideration should be given to preventing contamination in systems where parallel pump systems are used, especially if there is stagnant water when one of the pumps is not being used.

4 Biocontamination control techniques

1 Water purification systems should be sanitized using chemical or thermal sanitization procedures as appropriate fflproduction and distribution). The procedure and conditions used fflsuch as times and temperatures) should be suitable.

2 The following control techniques may be used alone or more commonly in combination:

maintenance of continuous turbulent flow circulation within water distribution systems reduces the propensity for the formation of biofilms the system design should ensure the shortest possible length of pipework;

) for ambient temperature systems, pipework should be isolated from adjacent hot pipes;

) dead legs in the pipework should be minimized through appropriate design, and as a guide should not significantly exceed three times the branch diameter as measured from the ID pipe wall to center line of the point-of-use valve where significant stagnation potential exists;

) pressure gauges should be separated from the system by membranes;

) hygienic pattern diaphragm valves should be used;

) pipework for steam-sanitized systems should be sloped and fully drainable;

) the growth of microorganisms can be inhibited by:

– ultraviolet radiation sources in pipework;

– maintaining the system heated fflgreater than 65 °C);

– sanitizing the system periodically using hot water guidance temperature > 70’°C);

– sanitizing the system periodically using superheated hot water or clean steam;

– routine chemical sanitization using ozone or other suitable chemical agents. When chemical sanitization is used, it is essential to prove that the agent has been removed prior to using the water. Ozone can be effectively removed by using ultraviolet radiation.

Incoming searches for Pharmaceutical Water Systems:

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Pharmaceutical Water System: principles for pharmaceutical water systems

Source: WHO

Pharmaceutics M Pharmacy Project Title – Example Summary Aim – B pharm Projects

Pharmaceutics M Pharmacy Project Title – Example Summary Aim – B pharm Projects

BIOAVAILABILITY STUDY AND COLONIC RESIDENCE TIME EVALUATION BY X-RAY OF ORNIDAZOLE FROM COATED TABLETS IN HEALTHY HUMAN VOLUNTEERS

Pharmaceutics M Pharmacy Project Title – Example Summary Aim – B pharm Projects

 

BIOAVAILABILITY STUDY AND COLONIC RESIDENCE TIME EVALUATION BY X-RAY OF ORNIDAZOLE FROM COATED TABLETS USING APPROVED PHARMACEUTICAL EXCIPIENTS IN HEALTHY HUMAN VOLUNTEERS

 

Summary

Aim                             :           1) To carry bioavailability study of Ornidazole from coated tablets by using pharmaceutical excipients and compare with marketed product.

2) To carry colonic residence time  evaluation by X-ray study of Ornidazole from coated tablets.

Drugs used                 :           Ornidazole 400 mg.

Subjects                      :           Eight healthy human male volunteers

Study design              :           Crossover design

Institution                   :

Principal Investigator:

Study Procedure:

Eight human healthy male subjects in the age group of 25-30 will be enrolled in the study after physical examination by a physician and standard laboratory tests.

Inclusion Criteria:

  1. Non-allergic to drug
  2. Healthy as per the physical examination and laboratory tests
  • Non-participation in any study/blood donation during preceding three months
  1. Written informed consent

Study design: Simple randomized crossover design

The subject will be treated with single oral dose of Ornidazole after overnight fasting.  In the crossover study, subjects will be given coated tablets of Ornidazole.  Blood samples will be collected at 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 30 hours.

The subject will be treated with single oral dose of placebo tablets after overnight fasting.  In the crossover study, subjects will be given placebo tablets of Ornidazole.  X-Rays will be taken at 2, 5, 8,12 and 24 hours.

Pharmaceutics M Pharmacy Project Title – Example Summary Aim – B pharm Projects PDF

Pharmaceutics M Pharmacy Project Title – Example Summary Aim – B pharm Projects Pharmaceutics M Pharmacy Project Title – Example Summary Aim – B pharm Projects

Treatments: Eight male volunteers shall be distributed in to two groups. A 2×2 cross over design shall be used in the study. Each volunteer in the two groups will receive the floating matrix tablets and commercial dosage form as                           .

The study consists of two treatments (Ornidazole coated, commercial).     Ornidazole 400 mg will be given by oral route in the form of coated tablets and blood samples will be collected at 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 30 hours.

A drug free interval of at least two weeks will be kept between the two treatments.  A standard breakfast will be served 2 hours after drug administration followed by standard lunch after 4 hours.

ORNIDAZOLE

Ornidazole is an anti infective / antibacterial and antiprotozaol drug available as 400mg, 500 mg and 1000 mg tablets for oral administration. Its chemical name is 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole.

The half-life of the drug is approximately 7.4 hours in plasma. Ornidazole is metabolised in liver through biotranformation reactions while excretion is mainly by  Urine.

ContraIndications:

Hypersensitivity to ornidazole or to other nitroimidazole derivatives

Adverse Reactions:

Somnolence, headache, nausea, vomiting, dizziness, tremor, rigidity, poor coordination, seizures, tiredness, vertigo, temporary loss of consciousness and signs of sensory or mixed peripheral neuropathy, taste disturbances, abnormal LFTs, skin reaction.

 


Physical properties:

Solubility                    :           It is slightly soluble in water, and soluble in chloroform.

Pka                             :           2.4 ± 0.1

Category                    :           It is a anti-infective and anti-protozoal agent

 

Pharmacokinetics

Bioavailability            :           >90 % by oral route

Absorption                 :           Absorbed from entire GIT.

Protein Binding         :           <15 %

Half life                      :           14.67 + 1.0 hrs

Dosage                       :          400 to 1000 mg daily.

 

 


APPROVAL OF THE ETHICAL COMMITTEE

 

The study entitled “Bioavailability study and colonic residence time evaluation by x-ray of Ornidazole from coated tablets in healthy human volunteers” has been approved / not approved for conducting in the healthy human volunteers.

 

[PDF PPT DOC] Pharmaceutical FILTER VALIDATION – Sterile Protocol FDA Guide

Pharmaceutical FILTER VALIDATION PDF DOC PPT- Sterile Protocol FDA Guide

FILTER VALIDATION

Do you know Pharmaceutical Filter validation importance? Pharmaceutical processes are validated processes to assure a reproducible product  within set specifications. Equally important is the validation of the filters used within the process, especially the sterilizing grade filters, which, often enough, are used before filling or the final processing of the drug product. In its Guideline on General Principles of Process Validation, 1985, and Guideline on Sterile Drug Products Produced by Aseptic Processing, 1987, the FDA makes plain that the validation of sterile processes is required by the manufacturers of sterile products. Sterilizing grade filters are determined by the bacteria challenge test. This test is performed under strict parameters and a defined solution (ASTM F 838-83).

In any case, the FDA nowadays also requires evidence that the sterilizing grade filter will create a sterile filtration, no matter the process, fluid or bioburden, found. This means that bacteria challenge tests have to be performed with the actual drug product, bioburden, if different or known to be smaller than B. diminuta and the process parameters. The reason for the requirement of a product bacteria challenge test is threefold. First, the influence of the product and process parameters to the microorganism has to be tested. There may be cases of either shrinkage of organisms due to a higher osmolarity of the product or prolonged processing times. Second, the filter’s compatibility with the product and the parameters has to be tested. The filter should not show any sign of degradation due to the product filtered. Additionally, rest assurance is required that the filter used will withstand the process parameters; e.g., pressure pulses, if happening, should not influence the filter’s performance.

Third, there are two separation mechanisms involved in liquid filtration: sieve retention and retention by adsorptive sequestration. In sieve retention, the smallest particle or organism size is retained by the biggest pore within the membrane structure. The contaminant will be retained, no matter the process parameters. This is the ideal. Retention

by adsorptive sequestration depends on the filtration conditions. Contaminants smaller than the actual pore size penetrate such and may be captured by adsorptive attachment to the pore wall. This effect is enhanced using highly adsorptive filter materials, for example,

Glassfibre as a prefilter or Polyamide as a membrane. Nevertheless, certain liquid properties can minimize the adsorptive effect, which could mean penetration of organisms. Whether the fluid has such properties and will lower the effect of adsorptive sequestration and may eventually cause penetration has to be evaluated in specific product bacteria challenge tests.

[PDF PPT DOC] FILTER VALIDATION - Sterile Protocol FDA Guide

Before performing a product bacteria challenge test, it has to be assured that the liquid product does not have any detrimental, bactericidal or bacteriostatic, effects on the challenge organisms. This is done utilizing viability tests. The organism is inoculated into the product

to be filtered at a certain bioburden level. At specified times, the log value of this bioburden is tested. If the bioburden is reduced due to the fluid properties, a different bacteria challenge test mode becomes applicable. If the reduction is a slow process, the challenge test will

be performed with a higher bioburden, bearing in mind that the challenge level has to reach 107 per square centimeter at the end of the processing time. If the mortality rate is too high, the toxic substance is either removed or product properties are changed. This challenge fluid is called a placebo. Another methodology would circulate the fluid product through the filter at the specific process parameters as long as the actual processing time would be. Afterwards, the filter is flushed extensively with water and the challenge test, as described in ASTM F838-38, performed. Nevertheless, such a challenge test procedure would be more or less a filter compatibility test.

Besides the product bacteria challenge test, tests of extractable substances or  articulate releases have to be performed. Extractable measurements and the resulting data are available from filter manufacturers for the individual filters. Nevertheless, depending

on the process conditions and the solvents used, explicit extractable tests have to be  performed. These tests are commonly done only with the solvent used with the drug product but not with the drug ingredients themselves, because the drug product usually

covers any extractables during measurement. Such tests are conducted by the validation services of the filter manufacturers using sophisticated separation and detection methodologies, as GC-MS, FTIR, and RP-HPLC. These methodologies are required, due to the fact that the individual components possibly released from the filter have to be identified and quantified. Elaborate studies, performed by filter manufacturers, showed that there is neither a release of high quantities of extractables (the range is ppb to max ppm per 10-inch element) nor have toxic substances been found. Particulates are critical in sterile filtration, specifically of injectables. The USP 24 (United States Pharmacopoeia) and BP (British Pharmacopoeia) quote specific limits of particulate level contaminations for defined particle sizes. These limits have to be kept and, therefore, the particulate release of sterilizing

grade filters has to meet these requirements. Filters are routinely tested by evaluating the filtrate with laser particle counters. Such tests are also performed with the actual product under process conditions to prove that the product, but especially process conditions, do

not result in an increased level of particulates within the filtrate.

Additionally, with certain products, loss of yield or product ingredients due to adsorption shall be determined. For example, preservatives, like  benzalkoniumchloride or chlorhexadine, can be adsorbed by specific filter membranes. Such membranes need to be saturated by the preservative to avoid preservative loss within the actual product. This preservative loss e.g., in contact lens solutions, can be detrimental, due

to long-term use of such solutions. Similarly, problematic would be the adsorption of required proteins within a biological solution. To optimize the yield of such proteins within an application, adsorption trials have to be performed to find the optimal membrane

material and filter construction.

Cases that use the actual product as a wetting agent to perform integrity tests require the evaluation of product integrity test limits. The product can have an influence on the measured integrity test values due to surface tension, or solubility. A lower surface tension,

for example, would shift the bubble point value to a lower pressure and could result in a false negative test. The solubility of gas into the product could be reduced, which could result in false positive diffusive flow tests. Therefore, a correlation of the product as a wetting agent to the, water wet values has to be done, according to standards set by the manufacturer of the filter. This correlation is carried out by using a minimum of three filters of three filter lots. Depending on the  product and its variability, one or three product lots are used to perform the correlation. The accuracy of such a correlation is enhanced by automatic integrity test

machines. These test machines measure with highest accuracy and sensitivity and do not rely on human judgement, as with a manual test. Multipoint diffusion testing offers the ability to test the filter’s performance and, especially, to plot the entire diffusive flow graph through the bubble point. The individual graphs for a water-wet integrity test can now be compared to the product wet test and a possible shift evaluated. Furthermore, the multipoint diffusion test enables the establishment of an improved statistical base to determine the product wet versus water-wet limits.

Look out here Pharmaceutical FILTER INTEGRITY TESTING – FDA Guideline on Sterile Drug Products

Pharmaceutical Filter Validation References:

  1. Cooper and Gunn’s. Tutorial Pharmacy by S.J.Carter.
  2. Pharmaceutical engineering; K. Sambamurthy
  3. Pharmaceutical engineering; principles and practices, C.V.S. Subrahmanyam
  4. Encyclopedia of pharmaceutical technology, vol 3, edited by James Swarbrick.
  5. Pikal, M.J.; Lukes, A.L.; Lang, J.E. Thermal decomposition of amorphous beta-lactam antibacterials. J. Pharm. Sci. 1977, 66, 1312–1316.
  6. Pikal, M.J.; Lukes, A.L.; Lang, J.E.; Gaines, K. Quantitative crystallinity determinations of beta-lactam antibiotics by solution calorimetry: correlations with stability. J. Pharm. Sci. 1978, 67, 767–773.
  7. Pikal, M.J.; Dellerman, K.M. Stability testing of pharmaceuticals by high-sensitivity isothermal calorimetry at 25_C: cephalosporins in the solid and aqueous solution states. Int. J. Pharm. 1989, 50, 233–252.
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[PDF] FILTER INTEGRITY TESTING – FDA Guideline on Sterile Drug Products DOC PPT

FILTER INTEGRITY TESTING

A filter integrity test is a critical unit operation commonly employed in the Pharma industry. FDA Guideline on Sterile Drug Products @ FILTER INTEGRITY TESTING is given below.

FILTER INTEGRITY TESTING

Sterilizing grade filters require testing to assure the filters are integral and fulfill their purpose. Such filter tests are called integrity tests and are performed before and after the filtration process. Sterilizing grade filtration would not be admitted to a process if the filter would not be integrity tested in the course of the process. This fact is also established in several guidelines, recommending the use of integrity testing, pre- and post-filtration. This is not only valid for liquid but also for air filters.

Examples of such guidelines are :

  1. FDA Guideline on Sterile Drug Products Produced by Aseptic Processing (1987):

Normally, integrity testing of the filter is performed after the filter unit is assembled and prior to use. More importantly however, such testing should be conducted after the filter is used in order to detect any filter leaks or perforations that may have occurred during filtration.

  1. The Guide to Inspections of High Purity Water Systems, Guide to Inspections of Lyophilization of Parenterals, and also the CGMP document 212.721 Filters state the following:
  2. The integrity of all air filters shall be verified upon installation and maintained throughout use. A written testing program adequate to monitor integrity of filters shall be established and followed. Results shall be recorded and maintained as specified in 212.83.
  3. Solution filters shall be sterilized and installed aseptically. The integrity of solution filters shall be verified by an appropriate test, both prior to any large-volume parenteral solution filtering operation and at the conclusion of such operation before the filters are discarded. If the filter assembly fails the test at the conclusion of the filtering operation, all materials filtered through it during that filtering operation should be rejected. Rejected materials may be refiltered using filters whose integrity has been verified provided that the additional time required for refiltration does not result in a total process time that exceeds the limitations specified in 212.111. Results of each test shall be recorded and maintained as required in 212.188(a).
  4. ISO 13408-1 First Edition, 1998-08-1, Aseptic Processing of Health Care Products, Part 1: General requirements: Section 17.11.1 Investigation, m. pre- and post-filter integrity test data, and/or filter housing assembly:
  5. 20.3.1. A validated physical integrity test of a process filter shall be conducted after use without disturbing the filter housing assembly. Filter manufacturer’s testing instructions or recommendations may be used as a basis for a validated method. Physical integrity testing of a process filter should be conducted before use where process conditions permit. ‘‘Diffusive Flow,’’ ‘‘Pressure Hold,’’ and ‘‘Bubble Point’’ are acceptable physical integrity tests.
  6. 20.3.2. The ability of the filter or housing to maintain integrity in response to sterilization and gas or liquid flow (including pressure surges and flow variations) shall be determined.
  7. USP 23, 1995, P. 1979. Guide to Good Pharmaceutical manufacturing Practice (Orange

FDA Guide, U.K., 1983):

  1. PDA (Parenteral Drug Association), Technical Report No. 26, Sterilizing Filtration of Liquids (March 1998):

Integrity tests, such as the diffusive flow, pressure hold, bubble point, or water intrusion tests, are non-destructive tests, which are correlated to the destructive bacteria challenge test with 107/cm2 B. diminuta. Derived from these challenge tests, specific integrity test limits are established, which are described and documented within the filter manufacturers’ literature. The limits are water-based; i.e., the integrity test correlations are performed using water as a wetting medium. If a different wetting fluid, such as a filter or membrane configuration, is used, the integrity test limits may vary. Integrity test measurements depend on the surface area of the filter, the polymer of the membrane, the wetting fluid, the pore size of the membrane, and the gas used to perform the test.

Wetting fluids may have different surface tensions, which can depress or elevate the bubble point pressure. The use of different test gases may elevate the diffusive gas flow. Therefore, appropriate filter validation has to be established to determine the appropriate integrity test limits for the individual process. Bubble Point Test Microporous membranes will fill their pores with wetting fluids by imbibing that fluid in accordance with the laws of capillary rise. The retained fluid can be forced from the filter pores by air pressure applied

from the upstream side. The pressure is increased gradually in increments. At a certain pressure level, liquid will be forced first from the set of largest pores, in keeping with the inverse relationship of the applied air pressure P and the diameter of the pore, d, described in the bubble point equation:

where g is the surface tension of the fluid, y is the wetting angle, P is the upstream pressure at which the largest pore will be freed of liquid, and d is the diameter of the largest pore.

When the wetting fluid is expelled from the largest pore, a bulk gas flow will be detected on the downstream side of the filter system (Fig. 7). The bubble point measurement determines the pore size of the filter membrane, i.e., the larger the pore the lower the bubble point pressure. Therefore, filter manufacturers specify the bubble point limits as the minimum allowable bubble point. During an integrity test, the bubble point test has to exceed the set minimum bubble point.

Manual bubble point test set up

 FILTER INTEGRITY TESTING

 

 

 

1.Diffusion Test

A completely wetted filter membrane provides a liquid layer across which, when a differential pressure is applied, the diffusive airflow occurs in accordance with Fick’s law of diffusion. This pressure is called test pressure and commonly specified at 80% of the bubble point pressure. In an experimental elucidation of the factors involved in the process, Reti simplified the integrated form of Fick’s law to read as follows:

where N is the permeation rate (moles of gas per unit time), D is the diffusivity of the gas in the liquid, H is the solubility coefficient of the gas, L is the thickness of liquid in the membrane (equal to the membrane thickness if the membrane pores are completely filled

with liquid), P (p1 _ p2) is the differential pressure, and r is the void volume of the membrane, its membrane porosity, commonly around 80%. The size of pores only enter indirectly into the equation; in their combination, they comprise L, the thickness of the liquid layer, the membrane being some 80% porous. The critical measurement of a flaw is the thickness of the liquid layer. Therefore, a flaw or an oversized pore would be measured by the thinning of the liquid layer due to the elevated test pressure on the upstream side. The pore or defect may not be large enough that the bubble point comes into effect, but the

test pressure thins the liquid layer enough to result into an elevated gas flow. Therefore, filter manufacturers specify the diffusive flow integrity test limits as maximum allowable diffusion value. The larger the flaw or a combination of flaw, the higher the diffusive flow.

Pressure Hold Test:

The pressure hold test is a variant of the diffusive airflow test. The test set-up is arranged as in the diffusion test except that when the stipulated applied pressure is reached, the pressure source is valved off. The decay of pressure within the holder is then observed as a function of time, using a precision pressure gauge or pressure transducer.

The decrease in pressure can come from two sources:

1) the diffusive loss across the wetted filter. Because the upstream side pressure in the  holder is constant, it decreases progressively as all the while diffusion takes place through the wetted membrane and

2) the source of pressure decay could be a leak of the filter system set-up. An  important influence on the measurement of the pressure hold test is the upstream air volume within the filter system. This volume has to be determined first to specify the maximum allowable pressure drop value. The larger the upstream volume, the lower will the pressure drop be. The smaller the upstream volume, the larger the pressure drop. This also means an increase in the sensitivity of the test, and also an increase of temperature influences, if changes occur. Filter manufacturers specify maximum allowable pressure drop values.

2.Water Intrusion Test:

The water intrusion test is used for hydrophobic ventand air membrane filters only. The upstream side of the hydrophobic filter cartridge housing is flooded with water. The water will not flow through the hydrophobic membrane. Air or nitrogen gas pressure is then applied to the upstream side of the filter housing above the water level to a defined test pressure. This is done by way of an automatic integrity tester. A period of pressure stabilization takes place over time frame, by the filter manufacturer’s recommendation, during which the cartridge pleats adjust their positions under imposed pressures.

After the pressure drop thus occasioned stabilizes, the test time starts, and any further pressure drop in the upstream pressurized gas volume, as measured by the automatic tester, signifies a beginning of water intrusion into the largest (hydrophobic) pores, water being incompressible. The automated integrity tester is sensitive enough to detect the pressure drop. This measured pressure drop is converted into a measured intrusion value, which is compared to a set intrusion limit, which has been correlated to the bacteria challenge test. As with the diffusive flow test, filter manufacturers specify a maximum allowable water intrusion value. Above this value, a hydrophobic membrane filter is classified as non-integral.

References for FILTER INTEGRITY TESTING:

  1. Cooper and Gunn’s. Tutorial Pharmacy by S.J.Carter.
  2. Pharmaceutical engineering; K. Sambamurthy
  3. Pharmaceutical engineering; principles and practices, C.V.S. Subrahmanyam
  4. Encyclopedia of pharmaceutical technology, vol 3, edited by James Swarbrick.
  5. Pikal, M.J.; Lukes, A.L.; Lang, J.E. Thermal decomposition of amorphous beta-lactam antibacterials. J. Pharm. Sci. 1977, 66, 1312–1316.
  6. Pikal, M.J.; Lukes, A.L.; Lang, J.E.; Gaines, K. Quantitative crystallinity determinations of beta-lactam antibiotics by solution calorimetry: correlations with stability. J. Pharm. Sci. 1978, 67, 767–773.

Pikal, M.J.; Dellerman, K.M. Stability testing of pharmaceuticals by high-sensitivity isothermal calorimetry at 25_C: cephalosporins in the solid and aqueous solution states. Int. J. Pharm. 1989, 50, 233–252.

FILTER INTEGRITY TESTING PDF – FDA Guideline on Sterile Drug Products PDF

FILTER INTEGRITY TESTING DOC – FDA Guideline on Sterile Drug Products

FILTER INTEGRITY TESTING PPT

FILTER INTEGRITY TESTING – FDA Guideline on Sterile Drug Products is helpful we hope. If you have anything to this please write to us.

B.Pharmacy & M. Pharmacy Projects: Titles Project Work Topics {Pharmaceutics}

B.Pharmacy & M. Pharmacy Projects: Titles Project Work Topics {Pharmaceutics}

Hello Buddies. Here are few topics and title which can be used for B.Pharmacy & M. Pharmacy Projects in the final year. Particularly these are the Titles Project Work Topics for Pharmaceutics specialization. 

PHARMACEUTICS: B.Pharmacy & M. Pharmacy Projects: Topics For Project Work Of Pharmaceutics Students

 

  1. Formulation and evaluation of topical formulations of Bosweellic acids guggulosterones for the treatment of rheumatoid arthritis
  2. Supramolecular: Nanomedicine and nanotechnology pre-concentration, separation and recovery of toxic trace metal
  3. Supercritical fluid technology
  4. Studies on design and development of dissolvable oral drug delivery systems of a poorly water soluble non-steroidal anti-inflammatory drug
  5. Designing of a polyherbal formulation for metabolic disorder
  6. Development of lipidic drug delivery system for bioavailability improvement of the poorly water soluble antihypertensive drug
  7. Formulation, development of rapidly dissolving films containing anti-histaminic drug
  8. Formulation and Evaluation of colon targeted drug delivery systems
  9. Formulation, development and evaluation of controlled drug delivery of analgesics via novel routes
  10. B.Pharmacy & M. Pharmacy Projects: Titles Project Work Topics {Pharmaceutics}

b pharm projects topics and review articles:

  1. Rotary Tableting Press
  2. Finished Goods Quality Assurance.
  3. The Perfect Excipient
  4. Product Composition Affects Material Selection
  5. Fractional Experimental Design. Study of the Incompatibility of Benzocaine in Throat Lozenges
  6. Moisture content of tablet
  7. Stability of the colorant
  8. Changes in tablet hardness. friability. dissolution rate
  9. Formulation and evaluation of colon targeted drug delivery system of mebeverine hydrochloride
  10. Any significant pharmaceutical problem with the drug product related to its formulation, drug delivery and bio-availability.
  11. Methods and types of dosage form which already exsits in the market.
  12. Points you have to study and review for literature purpose:
  13. One should have to study the history of the drug thoroughly.
  14. Early and common problems related to exsisting dosage forms.

M.pharm project topics in pharmaceutics

  1. Drug-induced diseases and Teratogenicity
  2. Drug dependences, Drug abuse, addictive drugs and their treatment, complications.
  3. Introduction to drying processes – Study of Tray Dryers: fluidized Bed Dryer.
  4. Vacuum Dryer and Freeze Dryer.
  5. Viscosity-Imparting Agents in Disperse Systems
  6. Oral Aqueous Suspensions
  7. Topical Suspensions A review
  8. Bio-availability of drugs, including factors affecting it
  9. complete data base of drug available by any source like internet, libraries etc.
  10. Complete physico0chemical parameter of pure drug.
  11. Study of complete drug profile from authenticated sources like pharmacopoeias, FDA online sites etc.
  12. study of depth of the drug and its available formulations and problems related with that available problems.
  13. Development and assessment of Novel In-situ Ocular gels of Ketorolac Tromethamine
  14. Dissolution improvement of weakly soluble drugs using hot melt Extrusion Technology.
  15. Dissolution rate Enhancement of Glimepiride and olanzapine by spray drying technique.
  16. Enhancement of dissolution rate of aceclofenac with meglumin as a novel ternary component
  17. Formulation and estimate of Aceclofenac Topical Emulgels.

B.PHARMACY & M. PHARMACY PROJECTS: TOPICS FOR PROJECT WORK OF PHARMACEUTICS STUDENTS

  • Formulation and estimation of atomoxetine HCL buccal drug delivery system
  • Formulation and assessment of capecitabine tablets for colon specific drug delivery system
  • Formulation and Evaluation of cyclobenzaprine hydrochloride loaded sustained release microspheres.
  • Formulation and evaluation of diclofenac sodium matrix tablets using new natural polymer
  • Formulation and evaluation of duloxetine HCL delayed release enteric coated capsules
  • Formulation and evaluation of fast disintergrating tablets and films for carbinoxamine maleate
  • Formulation and evaluation of frusemide semi solid matrix capsules by liquid filling technology
  • Formulation and Evaluation of Glipizide microemulsion.
  • Formulation and evaluation of implantable drug delivery system for temozolamide
  • Formulation and evaluation of ornidazole topical emulgels
  • Formulation and Evaluation pantoprazole sodium enteric coated tablets using different super disintegrants.
  • Screening, optimization and characterization of polymers for orally dissolving films.

 

PHARMACEUTICS Project Topics: B.Pharmacy

 

Formulation, Evaluation And Validation Of Orally Disintegrating Rizatriptan Benzoate Tablet.

Sustained Release Effervescent Floating Bilayer Tablets A Review Of Novel Approach.

Nanocapsules: Nano Novel Drug Delivery System.

Formulation And Evaluation Of Atomoxetine Hydrochloride Sustained Release Tablets.

Nano-Particles Containing Anticancer Drug.

Solubility Enhancement Of Poorly Water Soluble Drug By Spherical Crystallization Technique.

In-Vitro Antiproliferative Activity Of M. Azedarach.

Impact And Management Tool For Identification And Reduction Of Human Errors In Pharmaceuticals Industry.

Solid Dispersion- A Review.

Validation-In Pharmaceutical Industry : Cleaning Validation – A Brief.

A Review On Gastro-Intestinal Drug Esomeprazole.

Effect Of Ascorbic Acid On Dissolution Stability Of Rifampicin In Market Fixed Dose Combination Products For Tuberculosis.

Prepration And Evaluation Of Nano-Emulsion Formulation By Using Spontaneous Emulsification.

Preparation Method, Properties And Crosslinking Of Hydrogel: A Review.

Formulation Development And In Vitro Evaluation Of Mouth Dissolving Tablets Of Pioglitazone Hydrochloride.

Formulation And Evaluation Of Orodispersible Tablets To Enhance Dissolution Rate Of Lamotrigine By Using Solid Dispersion Technique.

Formulation And Evaluation Of Metformin Hydrochloride Buccal Patch

 

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