SIGNIFICANCE OF PREFORMULATION STUDIES IN DESIGNING, FABRICATING FOR PHARMACEUTICAL DOSAGE FORMS
Journal Title: Journal of Biomedical and Pharmaceutical Research - Year 2015, Vol 4, Issue 6
Abstract
Prior to development of any formulations the physiochemical properties of drug should be known to the developer. Preformulation studies have a significant part to play in anticipating formulation problems and identifying logical path in liquid, semisolid and solid dosage form technology. The need for adequate drug solubility cannot be over emphasized. Stability studies in solution will indicate the feasibility of parental or other liquid dosage form and can identify methods of stabilization. In parallel solid-state stability by DSC, TLC and HPLC in the presence of tablet and capsule excipient will indicate the most acceptable vehicles for solid dosage form. Prior to the development of pharmaceutical dosage forms, it is essential that be valid fundamental physical and chemical properties of the drug molecule and other divided properties of the drug powder are determined. Preformulation is to make available and realize information regarding:1) the degradation process 2) any adverse conditions relevant to the drug 3) bioavailability 4) pharmacokinetics and formulation of similar compounds 6) toxicity. Preformulation influences a) selection of the drug candidate itself b) selection of formulation components c) API and drug product manufacturing processes d) determination of the most appropriate container closure system e) development of analytical methods f) assignment of API retest periods g) the synthetic route of API h) toxicological strategy i) to establish its compatibility with common excipients by observing caking, liquefaction, colour change, odour formation. It also gives directions for the development of formulation in choice of drug form, excipients, composition, physical structure, helps in adjustment of pharmacokinetics and bio pharmaceutical properties. In this review article we basically consider the various parameters should be keep in mind before to the fabrication of any formulations.
Authors and Affiliations
Amita Tilak*| Department of pharmacy G.S.V.M.Medical College Kanpur, Ranjana Sharma| Department of pharmacy G.S.V.M.Medical College Kanpur, Sudhir Singh Gangwar| Department of pharmacy G.S.V.M.Medical College Kanpur, Minakshi Verma| Department of pharmacy G.S.V.M.Medical College Kanpur, Ashish Kumar Gupta| Department of pharmacy V.B.S.Purvanchal University Jaunpur
Keywords
Related Articles
- EP ID EP3657
- DOI -
- Views 441
- Downloads 20
PREPARATION AND EVALUATION OF IMIQUIMOD LOADED SOLID LIPID NANOPARTICLES BASED TOPICAL GEL FORMULATION: PART-I
Solid lipid nanoparticles are at the forefront of the rapidly developing field of nanotechnology with several potential applications in drug delivery, clinical medicine and research as well as in other varied sciences....
Impact of Calcium-Vitamin D Supplements on the Dissolution Pattern of Ranitidine Hydrochloride Tablets: An in vitro Dissolution Study using UV Spectroscopy
The objective of this study was to evaluate the impact of Calcium-Vitamin D supplement formulations on the dissolution pattern of different Ranitidine Hydrochloride tablet formulations. This was an in-vitro dissolution s...
AN EMPIRICAL STUDY ON THE PREVALENCE OF CHILDREN WITH DISABILITY IN MANGALORE
Children with disability are an important social concern in the community. This study aims to report the different types of disability among school going children in Mangalore. Data were collected from the Inclusive Edu...
An Approach Based on Advantages over Conventional System
The convenience of administration and improved patient compliance are important in the design of oral drug delivery system which remains the preferred route of drug delivery inspite of various disadvantages. Oral deliver...
Pharmacognostical, Phytochemical, Pharmacological and Toxicological Review on Trichosanthesanguina Linn
Traditional medicine is widely spread globally and it is the almost exclusive source of primary health care for 80% of the world’s population. Herbal medicines are regarded by the public and some health care providers to...