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Related Concept Videos

Drug Product Stability01:16

Drug Product Stability

331
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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Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry

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Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

734
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...
734
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

820
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).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
820
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

397
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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The Role of Solid State Characterization in Predicting Stability of Solid Dosage Forms.

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Drug product stability ensures quality attributes remain within limits throughout its shelf-life. Physical instability in amorphous polymers can alter drug release and mechanical properties over time.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Drug product stability is critical for maintaining quality attributes and shelf-life.
  • Excipients, particularly amorphous polymers, are susceptible to physical instability and degradation.
  • Packaging material significantly impacts drug product protection and stability.

Purpose of the Study:

  • To provide an overview of physical changes affecting solid dosage form stability.
  • To discuss methods for monitoring these physical changes.
  • To illustrate how environmental factors influence solid dosage form quality over time.

Main Methods:

  • Literature review on physical instability in solid dosage forms.
  • Discussion of analytical techniques for monitoring physical changes.
  • Exploration of environmental factors impacting stability.

Main Results:

  • Physical ageing of amorphous polymers can lead to significant changes in solid dosage form properties.
  • Instability manifests as altered mechanical properties, homogeneity, drug release, and discoloration.
  • Environmental factors accelerate degradation pathways, affecting product quality.

Conclusions:

  • Understanding and monitoring physical instability is crucial for formulation development.
  • Amorphous polymer physical instability poses a significant challenge to solid dosage form quality.
  • Comprehensive stability assessment is essential for regulatory compliance and patient safety.