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Related Concept Videos

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

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

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

Bioavailability Enhancement: Drug Stability Enhancement and GI Retention

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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...
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Site-Targeted Drug Delivery Systems: Polymeric Carriers01:24

Site-Targeted Drug Delivery Systems: Polymeric Carriers

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Polymeric carriers enhance targeted drug delivery by increasing efficacy while minimizing off-target effects. These carriers comprise a biodegradable polymeric backbone integrated with functional elements that enable targeting, improve physicochemical properties, and regulate drug release.Targeting MechanismsThe targeting ability of polymeric carriers is mediated by a homing device, which is a molecular recognition component designed to selectively bind to specific tissues or cells. Monoclonal...
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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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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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Bioavailability Enhancement: Drug Solubility Enhancement01:16

Bioavailability Enhancement: Drug Solubility Enhancement

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Bioavailability is a critical factor in determining a drug's effectiveness. It refers to the proportion of a drug that enters the circulation when introduced into the body and is, as a result, able to have an active effect. Enhancing bioavailability is essential for drugs with poor solubility, as it can significantly impact their therapeutic efficacy. Various methods are employed to increase the solubility of drugs, thereby enhancing their bioavailability.Micronization and nanonization are...
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Related Experiment Video

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Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles
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Solid state drug-polymer miscibility studies using the model drug ABT-102.

Rajan Jog1, Rajeev Gokhale2, Diane J Burgess1

  • 1Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, United States.

International Journal of Pharmaceutics
|June 7, 2016
PubMed
Summary

This study investigated amorphous solid dispersions stability, finding Soluplus superior to PVP and HPMC. Spray drying yielded the most miscible amorphous solid dispersions with negative free energy of mixing.

Keywords:
Amorphous solid dispersionInteractionMiscibilitySolid-stateSpray dryingThermodynamics

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Area of Science:

  • Materials Science
  • Pharmaceutical Technology
  • Physical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) face storage stability challenges due to their inherent nature, high drug loads, and excipient interactions.
  • Understanding drug-polymer miscibility is crucial for developing stable ASDs.
  • Hygroscopic excipients can induce plasticization effects, further compromising stability.

Purpose of the Study:

  • To investigate drug-polymer miscibility for enhancing ASD stability.
  • To evaluate the impact of different polymers, ratios, and preparation methods on ASD characteristics.
  • To identify optimal stabilizers for amorphous solid dispersions.

Main Methods:

  • Solid-state miscibility study using Differential Scanning Calorimetry (DSC), Fourier-Transform Infrared Spectroscopy (FTIR), and Powder X-ray Diffraction (PXRD).
  • Preparation of amorphous solid dispersions via serial dilution, solvent evaporation, and spray drying.
  • Calculation of interaction parameters and free energy of mixing using melting point depression.

Main Results:

  • Spray drying proved most effective for generating amorphous solid dispersions with significant miscibility.
  • Soluplus demonstrated superior stabilization compared to PVP and HPMC, attributed to strong hydrogen bonding.
  • Negative free energy of mixing was observed in spray-dried dispersions, indicating enhanced drug-polymer miscibility.

Conclusions:

  • Soluplus is a highly effective stabilizer for amorphous solid dispersions, promoting strong drug-polymer miscibility.
  • Spray drying is the preferred method for producing stable and miscible amorphous solid dispersions.
  • Understanding drug-polymer interactions is key to overcoming stability issues in amorphous formulations.