Chemical properties of preformulation studies
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1. PREFORMULATION presented by SUNILBOREDDY 1
2. contents 1.Concept of preformulation 2.Steps in preformulation process 3.Physicochemical properties 4.Solubility 5.pKa determinations 6.Partition coefficient 7.pH- solubility profile 8.Prodrug approach 9.Polymorphism 10.Conclusion references 2
3. THE CONCEPT OF PREFORMULATION:- Almost all drugs are marketed as tablets, capsules or both. Prior to the development of these major dosage forms, it is essential that certain fundamental, physical and chemical properties of the drug molecule and other properties of the drug powder are determined. This information decides many of the subsequent events and approaches in formulation development. This first learning phase is known as preformulation Definition:- It can be defined as an investigation of physical and chemical properties of a drug substance - alone and or when combined with excipients. The overall objective of preformulation testing is to generate information useful to the formulator in developing stable and safe dosage forms with good bioavailability. 3
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