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Related Concept Videos

Drug Product Stability01:16

Drug Product Stability

303
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...
303
Bioavailability Enhancement: Drug Stability Enhancement and GI Retention01:05

Bioavailability Enhancement: Drug Stability Enhancement and GI Retention

238
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...
238
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

198
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,...
198
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

222
Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
222
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

659
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...
659
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry

609
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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Photostability Issues in Pharmaceutical Dosage Forms and Photostabilization.

Karthik Yadav Janga1, Tamara King1, Nan Ji1

  • 1Department of Pharmaceutics and Drug Delivery, The University of Mississippi, University, MS, 38677, USA.

AAPS Pharmscitech
|September 15, 2017
PubMed
Summary

Photodegradation significantly impacts drug quality and stability. Understanding photodegradation mechanisms and kinetics is crucial for developing stable pharmaceutical products and enhancing photostability.

Keywords:
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Area of Science:

  • Pharmaceutical Science
  • Drug Degradation Studies
  • Photochemistry

Background:

  • Photodegradation is a primary cause of drug degradation, affecting therapeutic agent and excipient stability.
  • Light sensitivity poses challenges to pharmaceutical product quality and shelf-life.
  • Regulatory bodies like the International Conference on Harmonization (ICH) mandate photodegradation assessments.

Purpose of the Study:

  • To review photodegradation mechanisms and kinetics of photosensitive pharmaceutical components.
  • To explore factors influencing photodegradation rates.
  • To discuss strategies for enhancing photostability in pharmaceutical formulations.

Main Methods:

  • Literature review of photodegradation mechanisms.
  • Analysis of factors affecting photodegradation kinetics.
  • Examination of light-induced degradation in lipids and polymers.
  • Overview of formulation and manufacturing strategies for photostability.

Main Results:

  • Photodegradation pathways and kinetics vary significantly based on drug structure and environmental factors.
  • Light exposure can lead to substantial degradation of sensitive drugs and excipients.
  • Various factors influence the rate of photodegradation, including light intensity and wavelength.
  • Photosensitive lipids and polymers are also susceptible to light-induced degradation.

Conclusions:

  • Knowledge of photodegradation is essential for pharmaceutical product development and regulatory compliance.
  • Formulation and manufacturing strategies can mitigate photodegradation.
  • Improving photostability is key to ensuring drug efficacy and safety over time.