Preformulation studies powerpoint presentation.asp


Preformulation characterization studies generally include accelerated stability (stress) studies, stability-indicating analytical method development, and other physiochemical characterizations designed to pinpoint potential product candidate stability problems and enable formulation optimization. It is used to study the influence on dissolution of particle size, surface area & mixing with excipients. STABILITY ANALYSIS Development of a drug substance into a suitable dosage form requires the Preformulation stability studies of drug under the following categories:- [1] Solid state stability. [2] Solution state stability. A 'read' is counted each time someone views a publication summary (such as the title, abstract, and list of authors), clicks on a figure, or views or downloads the full-text. Contact Info. ICH APPS PRIVATE LIMITED 2-22-311/171/C, ADDAGUTTA SOCIETY,H.M.T. COLONY,BALAJI NAGAR,KUKATPALLY, Hyderabad, Telangana, India,500072 3 1. INTRODUCTION Define: It is the study of the physical and chemical properties of the drug prior to compounding process. Preformulation commences when a newly synthesized drug shows sufficient ... Preformulation characterization studies generally include accelerated stability (stress) studies, stability-indicating analytical method development, and other physiochemical characterizations designed to pinpoint potential product candidate stability problems and enable formulation optimization. The last activity performed in pre-formulation studies is the compatibility studies, wherein the physical and chemical stability of the drug molecule is studied in presence of excipients. Obviously, the choice of excipients is dictated by the type of dosage form to be developed. Preformulation studies