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Related Concept Videos

In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

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...
In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

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, maintaining...
In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

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...
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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...
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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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Correction: Gottschalk et al. Predicting Throughput and Melt Temperature in Pharmaceutical Hot Melt Extrusion. <i>Pharmaceutics</i> 2022, <i>14</i>, 1757.

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A Freeze-Thawing Method to Prepare Chitosan-Poly(vinyl alcohol) Hydrogels Without Crosslinking Agents and Diflunisal Release Studies
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Solid crystal suspensions containing griseofulvin--preparation and bioavailability testing.

Elena Reitz1, Chris Vervaet2, Reinhard H H Neubert3

  • 1Institute of Pharmaceutics and Biopharmaceutics, Heinriche-Heine-University, Duesseldorf, Germany.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|October 31, 2012
PubMed
Summary
This summary is machine-generated.

Solid Crystal Suspension (SCS) technology successfully scaled up for poorly soluble drugs. Hot melt extrusion improved drug bioavailability 3.5-fold compared to physical mixtures, confirming SCS efficacy.

Keywords:
CrystallizationDispersionExtrusionGranulationSuspension

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Synthesis and Assay of Vibrio Quorum Sensing Inhibitors
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Synthesis and Assay of Vibrio Quorum Sensing Inhibitors

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Materials Science

Background:

  • Improving bioavailability of poorly soluble drugs is crucial in pharmaceutical research.
  • Drug particle size reduction remains a key strategy for enhancing drug bioavailability.
  • Solid Crystal Suspension (SCS) technology disperses drug particles in a soluble carrier via hot melt extrusion.

Purpose of the Study:

  • To demonstrate the scale-up of SCS technology using standard lab-scale extrusion equipment.
  • To identify critical process parameters for successful SCS formulation via hot melt extrusion.
  • To confirm the enhanced bioavailability of SCS formulations through in vivo studies.

Main Methods:

  • Scale-up of SCS technology to lab-scale twin-screw extrusion equipment.
  • Systematic variation of screw speed and barrel temperature as critical process parameters.
  • Extrusion, milling to granules, tableting, and subsequent bioavailability testing in beagle dogs.

Main Results:

  • Identified process parameters that yield extrudates with rapid dissolution rates.
  • Achieved a 3.5-fold increase in drug bioavailability compared to physical mixtures.
  • SCS formulation demonstrated slightly higher bioavailability than the marketed product.

Conclusions:

  • Successfully scaled up SCS technology to lab-scale extrusion equipment.
  • Confirmed the concept of SCS technology for enhancing drug bioavailability.
  • SCS technology offers a viable approach for improving the delivery of poorly soluble drugs.