Characterization of Pure Drug and Drug-Excipient Compatibility Studies of Tadalafil

Shahul Hameed K.M*, Arun Kumar M and Dhanapal C.K
Department Pharmacy, Annamalai University, Annamalai Nagar-608002, Tamilnadu, India

ABSTRACT
Studies of drug-excipient compatibility represent an important phase in the preformulation stage of the development of all dosage forms. Thus any material used in the pharmaceutical drug product will be required to be manufactured under appropriate Good Manufacturing Practices (GMP) and supplied under Good Distribution Practices (GDP). The exact definition of GMP or GDP will depend on the material in question (e.g. Excipient, active pharmaceutical ingredient, packaging etc). The potential physical and chemical interactions between drugs and excipients can affect the chemical, physical, therapeutical properties and stability of the dosage form. Appearance of single DSC endothermic peak and in the FT-IR results, changes observed in the vibrational frequencies associated with amide, acid and chloride groups of the reactants prove to be effective diagnostic features to confirm the formation of molecular complexes. Different Thermal and Non-thermal method of analysis is also discussed. Once the type of interaction is determined we can take further steps to improve the stability of drug and dosage form. Drug excipient interaction studies carried out which shows there was no chemical interaction between the drug and the polymers.
Keywords: Excipient, Active Pharmaceutical Ingredient, Excipients, GMP, FT-IR