Email this article NOVEL TECHNOLOGY USED IN THE PREFORMULATION STUDY: A REVIEW
Abstract
Preformulation is a study which deals which provides the framework for drug’s combination with pharmaceutical ingredients in the fabrication of dosage form. Preformulation study is to develop the elegant dosage form by the establishing kinetic rate profile, compatibility with the other ingredients, establish physicochemical parameter and polymorphism of the new drug. Among these properties the preformulation also provide the information regarding degradation process, adverse condition relevant to the drug, bioavailability, pharmacokinetics, toxicity, drug stability, partition coefficient, dissolution rate, and polymorphic forms. Preformulation studies strengthen the scientific foundation of the guidance, provide regulatory relief and conserve resources in the drug development and evaluation process, improve public safety standards, enhance product quality, facilitate the implementation of new technologies. According to ICH, all technical requirements for the application of drug approval were homonized in CTD format which are scientifically more elaborate by USFDA in QoS-QbR format. QbR is based on the principle of Quality by Design (QbD) which increased efficiently in the FDA review process.
References
Vilegave kailsah, Vidyasagar Gali, “Preformulation Studies of Pharmaceutical New Drug Molecule and Products; An Overview” .2013; 1(3): 2321-3647.
Lachman Leon, Lieberman Herbert A. and Kanig Joseph L. “The Theory and Pharmaceutical of Industrial Pharmacy”. Varghese publishing house, third edition, 171-196.
Gopinath R., Naidu R.A.S., “Pharmaceutical Reformulation Studies-Current Review” International Journal of Pharmaceutical and Biological Archives, 2011; 2(5):1391-1400.
Sahitya G., Krishna moorthy B., Muthukumaran M., “Importance of Preformulation Studies in Designing Formulations for Sustained Release Dosage Form”, ISSN-975-766X.
Ajay, Bemis, G.W. and Murcko, M.A. “Designing libraries with CNS activity”. J Med. Chem., 1999; 42: 4942–51.
Tushar Lathiya, Akhilesh D., Prabhakara.P, J.V. Kamath “Preformulation Studies of Controlled/Sustained Release Formulation: An Overview”. ISRJP, 2012; 3(5): ISSN 2230-8407.
J. Walter, Jr Weber, Chin Yu-Ping, “Determination of Partition Coefficient And Aqueous Solubility by Reverse Phase Chromatography-1”, WAT Res., 1986; 20(11): 1422-1442.
Qin-Wei Tong, “Pharmaceutical Preformulation:Integrated Drug Product Development Process”. University of Utah. July 2006.
Keseru, G.M., Molnar, L. And Greiner, I. “A Neural Network Based Virtual High Throughput Screening Test for the Prediction of CNS Activity”. Comb. Chem. High Throughput Screen, 2000; 3: 535–40.
Gibson Mark, “Pharmaceutical Guide from Candidate Drug Selection To Commercial Dosage Form”, 21-88.
Pathare Beebe, Tambe Vrushali, Patel Vandana, “A Review on Various Analytical Methods Used In Determination of Dissociation Constant”, International Journal of Pharmacy and Pharmaceutical Science, 2014; 6(8): ISSN-0975-1491.
Nicklaus, M.C., Milne, G.W. and Zaharevitz, D., “Chem-X and Cambridge:Comparison of Computer Generated Chemical Structures With X-Ray Crystallographic Data”. J Chem. Inf. Compute. Sci., 1993; 33: 639–46.
Marjamaki Marko, Keskinen Jorma, “Technologies for Measuring Paticulates”, 248-256.
Carr, R.L. “evaluating flow properties of solid” Chem.Eng., 1965; 72: 163-168
Sadowski, J. And Kubinyi, H. “A Scoring Scheme for Discriminating Between Drugs and Nondrugs”. J Med. Chem., 1998; 41: 3325–3329.
Mitchell, T. 2006. Personal communication: Cambridge, UK.
Paul Kippax Dr, “Measuring Particle Size Using Modern Laser Diffraction Techniques”, Chem-Europe.Com,UK, WR14 1*2
Tushar Lathiya, Akhilesh D., prabhakara P., J.V Kamath, “Preformulation Studies of Controlled/Sustained Release Formulations: An Overview”, IRJP, 2012; 3(5).
Weissing volkmar, pettinger K Tacy, and Murdock Nicole, “Nanopharmaceuticals Products On The Market”. Internation Journal of Nanomedicine.
Savjani Ketan T., Gajjar Anuradha K., Savjani Jigana K., “Drug Solubility: Importance And Enhancement Technique”, ISRN Pharm., 2012; 195727.
Gibson Mark, “Pharmaceutical Preformulation and Formulation,” second edition, 188-246.
Gupta M, Patel G, Nimesh S, Madhulika K. “Enhancement of Dissolution Rate of Ibuprofen By Preparing Solid Dispersion Using Different Methods”. Int J Pharm and Pharm Sci, 2011; 3(3): 204-06
Rutkowska Ewelina, Pajak Karolina & Jozwiak “Kryzsztof. Lipophilicity- Methods of Determination and Its Role In Medical Chemistry”. Aata Polniae Pharmaceutical Drug Research, 2013; 70(1): 3-18.
SourceURL:http://chemwiki.ucdavis.edu/Physical_Chemistry/Acids_and_Bases/Solubilty/Common_Ion_Effect
Patel, Niraja, "Development and Characterization of Ternary Solid Dispersion Granules of Poorly Water Soluble Drugs: Diflunisal And Mefenamic Acid". Thesis and Dissertations. (2011) Paper 672
Manallack David T, “The Pka Determination of Drug Discovery, Perspective Medicinal Chemistry”. 2007; 1 : 25-38.
Bulk Density and Tapped density of powders, document QAS/11. 450 March 2012.
Babic Sandra, Horvath J.M Alka, Pavlovic Mtavdzic Dragana, Macan-Kastelan Marija, “Determination of Pka Values of Active Pharmaceutical Ingredients, Trends In Analytical Chemistry”. 2007; 26(11).
Sahid Mahanand Naji, Darwis Yusrida, Khiong Peh Kok, “Aerodynamic Characterization of Marketed Inhaler Dosage Forms: High Performance Liquid Chromatography Assay Method for the Determination Buclesonide”. 2010; 4(12): 878-884.
Reijega jetse, Hoof van Arno, Loon van Antonie, Teunissen Bram, “Development of Methods of Determination of Pka Values, Analytical Chemistry Insights”. 2013; 8: 53-71.
Lumay G., Baschini F., Traina K., Bontempi S., Remy J.C., “Powder Technology”, Measuring the flowing properties of powders and grains”. 2012; 224: 19-27.
Partition and Distribution coefficients, RSC Advancing the chemical science, Reckitt Benckiser.
Pratap Surya Singh, Vivek Kushwah, Rathore Puneet, Jain Pritam, Jaiswal Satish. “Determination of Partition Coefficient of Salicylic Acid between N-Octanol and Distilled Water”. 3 (2): 2145-2150.
Chawla Garima, Gupta Piyush, Thilagavathi R., “Characterization of Solid-State Forms Of Celecoxib”. European Journal of Pharmaceutical Sciences, 2003; 20: 305-317.
Fairhurst David, Weiner Bruce, “A Guide To Determination of Particle Size- Making An Effective And Reliable Measurement: Brookhaven Instruments”. A Nova Instrument Company.
Patel Niraja, ‘Development and Characterization of Ternary Solid Dispersion Granules of Poorly Water Soluble Drugs: Diflunisal and Mefenamic Acid”. 2011; Thesis and dis.
Bajaj Sanjay, Sakhuja Neha, “Stability testing of pharmaceutical products”. Journal of Applied Pharmaceutical Science, 2012; 02(03): 129-138.
Leo Albert, Hansch Corwin and Elkine David, “Partition coefficient and their uses”. 1971; 71.
Larsson Jesper, “Methods For Measurement Of Solubility And Dissolution Rate Of Sparingly Soluble Drugs”. 2010.
Horiba scientific, “A Guidebook to Particle Size Analysis
Estime Nicolas, Teychene Sebastein, Autret Jean-Marie, “Influence of pH, Temperature and Impurities on the Solubility of an Active Pharmaceutical Ingredient”. API, DOI: 1542-6580.2099.
Tagalpallewar V.R, Ughade M.A., Indurwade Dr. N.H., “Enhancement Of Solubility Of Poorly Water Solunle Drug By Solid Dispersion Technique”. 2015; 6(2).
Gruner Klaus-Dieter, “Principle of Non-Contact Temperature Measurement”.
Takacs Krisztina, “Solubility-Ph Profile Dugs. Experience and Surprise in Logs Measurement”.
Nagendra kumar Dr. D., Keshavshetti G Ganesh, Ambarish Shardor, Kulkarni Pooja, “Enhancing Dissolution Rate of Naproxen Using Modern Technique”. 4(5): 929-939.
Gopinath R., Naidu R.A.S., ‘Pharmaceutical Preformulation Studies-Current Review”. 2001; 2(5): 1391-1400.
Niazi Sarfaraz K., “Handbook of Preformulation: Chemical, Biological, and Botanical Drugs RS”. 2006; 199. F67N53.
Vyas J, Patel J, Jain D. “Preparation and Characterization of Solid Dispersion of Modafinil for Improvement of Dissolution Profile”. Int J Pharm and Pharmaceutical Sci, 2012; 14(5): 348-352.
Natarajan R, Komala G, Ramcy TR, Swathi P, Mohan S. “Dissolution Enhancement Of Aceclofenacsolid Dispersion Prepared With Hydrophilic Carriers By Solvent Evaporation Methods”. IJRPC, 2014; 4(1): 83-89.
Bromberg L. “Cross Linked Polyethylene Glycol Networks as Reservoirs For Protein Delivery”. J Apply Poly Sci , 1996; 59: 459-466.
Verma PRP, Iyer SS. “Transdermal Delivery of Propranolol Using Mixedgrades of Eudragit: Design And In Vitro And In Vivo Evaluation”. Drug Dev. Ind Pharm, 2000; 26: 471-476.
Martin, A., Swarbrick.J, and Cammarata, “A.Physical Pharmacy: Phisical Chemical Principles In The Pharmaceutical Sciences”.3rd ed. Lea and Febiger, Philadelphia, 1983.
Bemis, G.W. and Murcko, M.A. “Properties of known drugs. 2. Side chains”. J Med. Chem., 1999; 42: 5095–5099.
Ajay, A., Walters, W.P. and Murcko, M.A. “Can We Learn To Distinguish Between “Drug-Like” And “Nondrug-Like” Molecules” J Med. Chem., 1999; 41: 3314–3324.
Comer, J. and Tam, K. “Lipophilicity Profile Les. Pharmacokinetic Optimization in Drug Research: Biological, Physicochemical and Computational Strategies”. Wiley: Zurich. 2001; 275–304.
Clark, D.E. and Pickett, S.D. “Computational Methods for the Prediction of ‘Drug-Likeness”. Drug Discov. Today, 2000; 5: 49–58.
Clark, D.E. “Computational Prediction Of Blood-Brain Barrier Permeation. Annual Reports In Medicinal Chemistry”. Elsevier San Diego, 2005; 403–15.
Wells, J.I “Pharmaceutical Preformulation”. Ells Hoowood Ltd. London, 1998; 25.
WDI the World Drug Index is available from Derwent Informatin, London, U.K. www.derwent.com.
Full Text: PDF
Refbacks
- There are currently no refbacks.
