Overview of drug formulation
Pharmaceutical products are formulated products with specific dosage forms for efficient delivery and product stability. Formulation development serves the purpose to determine the optimal dosage form, composition and manufacturing route for pharmaceutical products.
There are different kinds of pharmaceutical dosage forms such as:
• Oral tablets
• Topical ointments
• Injections for intravenous (IV), intramuscular (IM), or subcutaneous (SC) administration.
They require different production technologies and at the same time present different challenges for the study. DOE (design of experiments) is used as a routine for formulation development, and it evaluates all potential factors simultaneously, systematically, and quickly.
Steps of formulation development
A formulation contains the active pharmaceutical ingredient (API) and other inactive excipients.
• Firstly, excipient compatibility studies. Aiming to select viable excipients that are chemically and physically compatible with the API(s). The excipients selected during the excipient compatibility study are incorporated into the process feasibility study using DOE.
• Next, selecting the final excipients and define the optimal levels for all excipients in the formulation.
• Finally, designing and conduct a formulation optimization study to optimize the excipient levels in the final formulation system.
Creative Peptides offers design and optimization of formulations from early pre-clinical stage to Phase I and Phase II clinical trials and commercial manufacturing. We are dedicated to help you achieve the optimal formulation for your APIs.
1. Chaurasia, G. (2016). A review on pharmaceutical preformulation studies in formulation and development of new drug molecules. International Journal of Pharmaceutical Sciences and Research, 7(6), 2313.
2. Honmane, S. M. (2017). General Considerations of Design and Development of Dosage Forms: Pre-formulation Review. Asian Journal of Pharmaceutics (AJP): Free full text articles from Asian J Pharm, 11(03).