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Small Molecules

Solutions Small Molecules

Classical drug development employs working with small, chemically manufactured active substances, which served as the bedrock for medical research and therapeutics. These intracellular targeting substances are small molecules with a molecular weight of less than 900 Daltons (Da). Such substances are usually organic compounds with well-defined structures but with low drug specificity. They aid in regulating biological processes mainly through metabolic degradation. Some examples of these include 2-Aminooxyacetic acid (AOA or AOAA), a derivative of hydroxylamine, and acetylsalicylic acid commonly known as aspirin.

Due to their size, composition, pharmacokinetics, pharmacodynamics and suitability for certain drug forms over others, these small therapeutic molecules confer certain advantages over large ones or biologics. Some of these advantages include:

  • Increase in patient accessibility and compliance, since small molecules are majorly orally administered;
  • Broader spectrum of activity in comparison to biologics that are highly selective for their target molecule; and,
  • Easier synthesis as they involve less complex processes, thus, less rigorous manufacturing activities.

Compliance to international and state regulations is required to ensure that these products (drugs, medical devices, food, and blood components) are safe, pure, and effective once they are released to the market.

Current Good Manufacturing Practice (cGMP) is a regulation that is enforced by the Food and Drug Administration (FDA). This formal system of controls, when adequately put into practice, helps in preventing instances of contamination, mix-ups, deviations, failures, and errors, and ensures that drug products meet their quality standards.

Esco Pharma with its wide range of innovative and turnkey solutions, backed with its four (4) core technologies, enables various industries such as pharmaceuticals, nutraceuticals, and cosmeceuticals to comply with the internationally accredited GMP, as well as, industrial, environmental, and health and safety standards.


References:

  1. International Society for Pharmaceutical Engineering. (n.d.). What is GMP. Retrieved from: https://ispe.org/initiatives/regulatory-resources/gmp/what-is-gmp
  2. Nwibo, D., Levi, C., & Nwibo, M. (2015). Small Molecule Drugs; Down but Not Out: A Future for Medical Research and Therapeutics. IOSR Journal of Dental and Medical Sciences, 7(1), 70-77. Retrieved from: https://pdfs.semanticscholar.org/ae71/5df59f5d328d49640b0ad41375d09e102022.pdf
  3. U.S. Food and Drug Administration. (2018). Facts About the Current Good Manufacturing Practices (CGMPs). Retrieved from: https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps#:~:text=CGMPs%20provide%20for%20systems%20that,medications%20adequately%20control%20manufacturing%20operations.

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