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Hindi Pharmaceutical scale up for solid dosage forms
Shashank Tiwari and S P Mahapatra
National Institute of Pharmaceutical Education and Research, India
: J Pharm Drug Deliv Res
Abstract
Nowadays, natural products based analogues are valuable and shows potent pharmacological activity but does not give expected drug delivery. The objective of this abstract is to perform some of the important pre-formulation and formulation studies of New Chemical Entities (NCEs) to achieve the routes of enhancement. Prior to this, any screened NCEs will take part in clinical trial. It is mandatory to pass from physiochemical characterization and in-vivo / in-vitro stability profile of NCEs further to enter into drug delivery phase during intense preclinical studies. These are basic evaluation for physiochemical characterization such as aqueous stability, biorelevant media/solvent/pH solubility, degradation profile, partition coefficient, ionization constant, LogP/D, pKa, solid state characterization, polymorphism, thermal transformation, drug-excipient compatibility studies. In the next stage, development of analytical / bioanalytical methods, selection of compatible internal reference standard with NCEs at similar wavelength, formulation of dose for animal studies, bioavailability / toxicity/ metabolic studies and also comparison with authentic in-silico softwares are carried out which give some clues to get promising NCEs which may improve drug delivery approaches. It will help to provide regulatory relief and implementation in the drug delivery development and improve public safety standards.
Biography
