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Related Concept Videos

In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

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

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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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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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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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In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

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Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

Factors Affecting Dissolution: Particle Size and Effective Surface Area

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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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Formation of Dispersible Taohong Siwu Tablets
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Challenges of Dissolution Methods Development for Soft Gelatin Capsules.

Festo Damian1, Mohammad Harati2, Jeff Schwartzenhauer3

  • 1School of Pharmacy, University of Waterloo, 200 University Ave W, Waterloo, ON N2L 3G1, Canada.

Pharmaceutics
|February 9, 2021
PubMed
Summary

Developing soft gelatin capsules (SGCs) is crucial for delivering poorly water-soluble drugs orally. This review explores challenges in creating effective dissolution testing methods for SGCs to ensure drug quality.

Keywords:
dissolution method developmentdrug stabilityenzymes in dissolutiongelatin cross-linkingpoorly soluble drugssoft gelatin capsulessolubilitysurfactantstwo-tier dissolution testing

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems

Background:

  • Soft gelatin capsules (SGCs) are increasingly used for oral delivery of poorly water-soluble drugs.
  • Challenges exist in developing stable and bioavailable formulations for these drugs.
  • SGCs offer a method to overcome formulation hurdles and improve drug delivery.

Purpose of the Study:

  • To review the challenges in developing in vitro dissolution test methods for SGCs.
  • To discuss factors affecting the dissolution properties of SGCs.
  • To examine the impact of gelatin cross-linking on SGC dissolution.

Main Methods:

  • Literature review focusing on SGC formulation and dissolution testing.
  • Analysis of physicochemical and formulation factors influencing SGC dissolution.
  • Discussion of gelatin cross-linking effects on dissolution.

Main Results:

  • Poorly water-soluble drugs present formulation challenges for oral delivery.
  • Effective in vitro dissolution testing is essential for SGC quality control.
  • Physicochemical properties, formulation components, and gelatin cross-linking significantly impact SGC dissolution.

Conclusions:

  • Dissolution test method development for SGCs requires careful consideration of multiple factors.
  • Understanding these factors is key to ensuring the quality and performance of SGC drug products.
  • Further research into optimizing dissolution methods for SGCs is warranted.