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Body:Improving a drug's stability in the gastrointestinal (GI) tract is paramount for enhancing its bioavailability and therapeutic effectiveness. Various strategies are employed to protect the drug from the harsh gastric milieu and to ensure its release and absorption at the desired site within the GI tract.Polymer coatings are one such method used to shield drugs from the stomach's acidic environment. By preventing premature drug release, these coatings improve the bioavailability of unstable...
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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...
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Excipient Stability in Oral Solid Dosage Forms: A Review.

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Excipient properties critically impact pharmaceutical formulation. This review details drug-excipient interactions and their effects on solid oral dosage forms during manufacturing.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Excipients are crucial components in pharmaceutical dosage forms, influencing critical parameters like disintegration, dissolution, and shelf life.
  • Understanding drug-excipient interactions is essential for successful formulation development and ensuring final product quality.

Purpose of the Study:

  • To review physical and chemical instabilities of excipients.
  • To analyze incompatibilities between active pharmaceutical ingredients (APIs) and excipients in solid oral dosage forms.
  • To discuss the impact of these interactions on drug manufacturing processes.

Main Methods:

  • Literature review of existing studies on drug-excipient interactions.
  • Analysis of physical and chemical properties of common excipients.
  • Case examples illustrating various drug-excipient incompatibilities.

Main Results:

  • Excipient properties significantly affect drug formulation and stability.
  • Drug-excipient incompatibilities can arise from physical, chemical, or mechanical interactions.
  • These interactions can compromise the integrity and performance of solid oral dosage forms.

Conclusions:

  • Careful selection and evaluation of excipients are vital for robust pharmaceutical formulations.
  • Addressing drug-excipient interactions proactively minimizes manufacturing challenges and ensures product efficacy.
  • Further research into novel excipients and interaction mitigation strategies is warranted.