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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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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 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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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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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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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).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
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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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Formation of Dispersible Taohong Siwu Tablets
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Dissolution Study on Grape Polyphenol Hard Gelatin Capsule Dietary Supplements.

Weiting Lyu1,2, Thamer Omar3, Harna Patel1

  • 1New Use Agriculture and Natural Plant Products Program, Department of Plant Biology and Center for Agriculture and Food Ecosystems, Institute of Food, Nutrition & Health, Rutgers University, New Brunswick, NJ, United States.

Frontiers in Nutrition
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PubMed
Summary

Dissolution studies show grape seed extract (GSE) and resveratrol (RSV) capsules meet USP standards in simulated stomach conditions. However, GSE dissolution is inadequate in simulated intestinal conditions, indicating a need for formulation improvements.

Keywords:
UHPLC-QQQ/MSbioavailabilitygrape seed extractpolyphenolresveratrol

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Area of Science:

  • Pharmacology
  • Analytical Chemistry
  • Nutraceutical Science

Background:

  • Grape polyphenols, including grape seed extract (GSE) and resveratrol (RSV), are popular dietary supplements with potential health benefits.
  • Assessing the dissolution profiles of these supplements is crucial for ensuring their bioavailability and efficacy.
  • United States Pharmacopeia (USP) guidelines provide a framework for conducting dissolution studies.

Purpose of the Study:

  • To develop and validate methods for the dissolution testing of GSE and RSV dietary supplements using UHPLC-QqQ/MS.
  • To evaluate the dissolution performance of GSE and RSV capsules in two different pH environments simulating physiological conditions.
  • To determine the adequacy of general USP dissolution protocols for these supplements.

Main Methods:

  • Developed dissolution study methods following USP <2040> guidance for GSE and RSV capsules.
  • Utilized ultra-high performance liquid chromatography/triple quadrupole mass spectrometry (UHPLC-QqQ/MS) for quantifying key compounds.
  • Tested dissolution in 0.1 N HCl (pH 1.2) and 0.05 M acetate buffer (pH 4.6) using USP Apparatus 1 at 100 rpm with 900 ml medium volume over 120 minutes.

Main Results:

  • Resveratrol (trans-RSV) release from RSV capsules met USP standards in both dissolution media (pH 1.2 and 4.6).
  • GSE capsules showed adequate dissolution of four marker compounds (gallic acid, catechin, epicatechin, procyanidin B2) in HCl (pH 1.2).
  • GSE capsules failed to achieve 75% release of marker compounds within 60 minutes in acetate buffer (pH 4.6).

Conclusions:

  • Standard USP dissolution protocols are suitable for RSV capsules in both tested pH conditions and for GSE capsules in acidic (pH 1.2) conditions.
  • The dissolution of GSE capsules in a neutral to slightly acidic buffer (pH 4.6) is insufficient, suggesting potential bioavailability issues.
  • Further formulation optimization is needed to enhance GSE dissolution across a wider pH range, potentially improving its in vivo efficacy.