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Related Concept Videos

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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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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Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

414
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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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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An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules
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The differences between the branded and generic medicines using solid dosage forms: In-vitro dissolution testing.

Mubarak Nasser Al Ameri1, Nanda Nayuni2, K G Anil Kumar3

  • 1William Harvey Research Institute, Barts and The London, School of Medicine and Dentistry, Queen Mary University of London EC1M 6BQ, UK ; UAE General Hospital, Abu Dhabi, United Arab Emirates.

Results in Pharma Sciences
|March 11, 2015
PubMed
Summary
This summary is machine-generated.

Dissolution testing revealed significant differences in how some generic medicines dissolve compared to their brand-name counterparts. These variations in drug dissolution rates raise questions about the interchangeability of generic drugs.

Keywords:
AbsorptionDifferences between the branded and generic medicinesDissolution methodsIVIVCIn-vitro dissolution

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Product Quality Assessment

Background:

  • Dissolution testing measures the rate at which a substance dissolves, crucial for predicting in vivo bioavailability and ensuring bioequivalence.
  • Standardized dissolution conditions (liquid/solid interface, solvent, temperature) are essential for reliable drug product assessment.

Purpose of the Study:

  • To compare the dissolution behavior of innovator (reference) solid dosage forms with their generic counterparts.
  • To identify potential differences in drug release profiles between branded and generic medications.

Main Methods:

  • 37 medicines (13 branded, 24 generic) were tested in quadruplicate using a Pharma Test dissolution tester.
  • Testing followed British Pharmacopeia, European Pharmacopeia, and US Pharmacopeia standards.
  • Dissolution rates were quantified using ultra-violet spectrophotometry.

Main Results:

  • While most medicines met pharmacopoeial specifications (85% dissolution in 60 min), significant dissolution rate differences were observed for some generics.
  • Examples include slower dissolution (omeprazole), incomplete dissolution (nifedipine), and faster dissolution (meloxicam) compared to branded products.
  • Some generics failed to meet EMA/FDA guidelines, with diclofenac sodium 50 mg being an example of a product not achieving 85% dissolution in 60 min.

Conclusions:

  • Most tested medicines adhered to pharmacopoeial limits, but notable variations in generic drug dissolution were identified.
  • These dissolution differences challenge the assumed interchangeability between branded drugs and their generic alternatives, as well as among different generic products.
  • Further investigation into drug dissolution profiles is warranted to ensure therapeutic equivalence and patient safety.