MANAGING EXCIPIENTS AND ACTIVE PHARMACEUTICAL INGREDIENTS IN THE PROCESS FORMULATION: AN EXPLORATARY STUDY
Author(s):
Durgesh Mani, Dr.Satendra Kumar, Shashank tiwari, Dr. Shashank Tiwari
Keywords:
Food products, population, co-processed excipients, randomized clinical trial.pharmaceutical ingredients
Abstract
Pharmaceutical excipients are chemicals that are included in a pharmaceutical dosage form for reasons other than direct therapeutic action, such as to facilitate the manufacturing process, to preserve, maintain, or increase stability, or to improve bioavailability or patient acceptability. APIs and inactive molecules are known as excipients are both classified as pharmaceutical raw materials. Pharmaceutical active ingredients (APIs) are the active elements of medication that allow it to have the desired pharmacological effect, whereas excipients are inert chemicals used to transport the API. Because of safety concerns, regulatory agencies throughout the world have devoted special attention to the excipients, food components, and active pharmaceutical ingredients (APIs) used in paediatric formulations in recent years. Surprisingly few excipients have undergone a randomised controlled study in a juvenile subpopulation, despite the Federal Food, Drug, and Cosmetic Act of 1938 requiring such testing before incorporation into formulations. Present research work aims at analyzing excipients and active pharmaceutical ingredients and their incorporation into the formulation. Based on an evaluation of previous studies undertaken by research, some of the conclusions and recommendations are presented inthisstudy.
Article Details
Unique Paper ID: 157262

Publication Volume & Issue: Volume 9, Issue 6

Page(s): 426 - 432
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