Excipients

About Excipients

ExcipientsExcipients, in addition to the main drug in the drug preparation of additional substances, can also be called excipients. The general requirements for excipients are stable nature, no contraindications with the main drug, no side effects, does not affect the efficacy, at room temperature is not easy to deformation, dry crack, mold, insects, harmless to humans, no physiological effects, no chemical or physical effects with the main drug, does not affect the determination of the content of the main drug. A medicinal mixture (e.g. syrup, lard or liquid petroleum jelly) that does not react chemically, to which a drug with therapeutic effect is added or by which other components are glued together. An inactive substance (such as gum arabic, molasses, lanolin or starch) that constitutes an excipient of a drug or antigen; in particular, a substance added to a drug mixture to give the mixture a viscosity for the preparation of pills or tablets when there is a sufficient amount of liquid in the mixture.

Selecting the Right Excipients

Selecting one or more excipients for a drug formulation is an important step in drug development. Carefully selected excipients can reduce production costs through versatility or enhance the patient experience by providing taste-masking properties. Excipients must best fit the intended dosage form of the drug, exhibit good organoleptic properties, comply with pharmacopeial regulations, be easy to procure and work effectively. The right excipient will have the ideal pharmacokinetic profile for your intended drug application. It will also work well with your existing equipment or fit into your manufacturing program.

Determinants

Deciding factors may include the intended use of the compound, the amount of compound required (grams to tons), or environmental conditions that may affect the excipient. Other considerations include potential toxicity, chemical source, and other special factors. For example, a plant-based excipient may be chosen over one of animal origin (gelatin).

CD Formulation is a leading manufacturer of excipients, serving the pharmaceutical industry to help it improve the performance of its products. We can provide pre-formulation, formulation, analysis and customized pharmaceutical excipients services to meet customer needs and formulation challenges. If you have any requirements for excipients, please contact us by phone or email, and our colleagues will reply to you within 2-4 working days.

References

  1. Metry, M., and J. E. Polli. Evaluation of Excipient Risk in BCS Class I and III Biowaivers. The AAPS Journal, 2022, 24(1).
  2. Sill, K. N. , and B. T. Sullivan. POLYMER EXCIPIENTS FOR DRUG DELIVERY APPLICATIONS:, US20210214496A1[P]. 2021.

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