Preformulation introduction and organoleptic properties.pptx

..Preformulation introduction and organoleptic properties.pptx..

1. Preformulation studies PRESENTED TO PRESENTED BY DR.SHAILESH.T SHREYA UG DEPARTMENT OF PHARMACEUTICS M PHARM 1 ST YEAR JSS COLLEGE OF PHARMACY –MYSURU QUALITY ASSURANCE

2. 1.Introduction 2.Defination 3.Objective and concepts of preformulation 4.Preformulation parameters 5.Benefits 5.Organoleptic properties 6.References C ontents

3. Prior to the development of any dosage form , it is essential that the physical chemical and fundamental properties of the drug molecule must be investigated. Preformulation is the first step in the rational development of a drug substance. It’s a branch of pharmaceutical sciences that utilizes biopharmaceutical principles to find the pharmaceutical properties of the drug molecule . Introduction

4. Investigation of physciochemical properties of a new drug compond that could affect drug performance and development of an efficious dosage form . It is the phase of reasearch and development characterized physical and chemical properties of a drug molecule in order to develop safe effective and stable dosage form. Definition

5. The preformulation investigations confirm that there are no significant barriers to the compound’s development as a marketed drug. To establish the necessary physicochemical parameters of a new drug substance To establish compatibility of drug with excipients The formulation scientist uses these informations to develop dosage forms Objectives and concepts of preformulation

6. Bulk characteristic Organoleptic properties Particle size & surface area Crystallinity & polymorphism Solubility Analysis Aqueous solobility Dissolution Stability analysis Solid state and solution state stability Oxidation Hydrolysis Photolysis polymerization Physial characteristic Chemical characteristic Preformulation parameters

7. Gives direction for development of formulation in choice of dosage form , excipents , compostion , physical compatibility Helps in adjustment of pharmacokinetic biopharmaceutical properties Support for process development of drug substance Support for development of PAT(Process Analytical Technology) Benefits

8. Color Odour Taste Off -white Pungent Acidic Cream - Yellow Sulfurous Bitter Shiny Fruity Sweet Tan Aromatic Tasteless Odourless Bland Intense Organoleptic properties are the aspects that can be experienced through one’s senses like taste, smell, sight, touch. The color , odour and taste of the new drug must be recorded using descriptive terminology. Organoleptic properties

9. color is generally a function of drug’s inherent chemical structure relating to a certain level of unsaturation. Color intensity relates to extend of conjugated unsaturation as well as the presence of chromophores . The substance may exhibit an inherent odor characteristic of major functional group present. Taste is considered as unpalatable , consideration is given to the use of a less soluble chemical form of the drug Both of these can be suppressed by using appropriate flavours and excipients. Color Odour &Taste Organoleptic properties

10. Leon Lachman , Lieberman H A and Joseph L K: The Theory and Practice of Industrial Pharmacy. Varghese publishing house, Bombay. Vilegave , K., Vidyasagar , G. and Chandankar , P., 2013. Preformulation studies of pharmaceutical new drug molecule and products: An Overview.  The American Journal of Pharmacy . Verma , G. and Mishra, M.K., 2016. Pharmaceutical preformulation studies in formulation and development of new dosage form: A review.  Int. J. Pharma Res. Rev ,  5 (10). Jain NK and Sharma SN: A Text book of professional pharmacy . Brahmankar DM and Jaiswal SB: Absorption of drugs in:. Biopharmaceutics and Pharmacokinetics A treatise. References

11. Thank you