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Related Concept Videos

Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

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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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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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In Vitro Drug Dissolution: Alternative Methods01:17

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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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Bioavailability Enhancement: Drug Solubility Enhancement01:16

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

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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).
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Body: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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Spray Encapsulation as a Formulation Strategy for Drug-Based Room Temperature Ionic Liquids: Exploiting Drug-Polymer

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Active pharmaceutical ingredient-based ionic liquids (API-ILs) offer enhanced solubility for poorly water-soluble drugs. Microencapsulating these API-ILs in polymers creates stable powders for oral solid dosage formulations.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Poorly water-soluble drugs present significant formulation challenges, limiting bioavailability and therapeutic efficacy.
  • Active pharmaceutical ingredient (API)-based ionic liquids (API-ILs) offer a novel approach to overcome solubility limitations.
  • Traditional amorphous solid dispersions (ASDs) can suffer from in vivo recrystallization, impacting drug stability and bioavailability.

Purpose of the Study:

  • To investigate the formulation of a model API-IL, 1-butyl-3-methyl imidazolium ibuprofenate, into a stable oral solid dosage form.
  • To explore the use of spray drying for creating high-loading API-IL/polymer microcapsules.
  • To elucidate the mechanism of high-loading formulation and its impact on physical properties and dissolution.

Main Methods:

  • Synthesis and characterization of 1-butyl-3-methyl imidazolium ibuprofenate.
  • Spray drying of API-IL/polymer mixtures at high loadings (up to 75% w/w).
  • Analysis using modulated differential scanning calorimetry (mDSC), hot-stage microscopy (HSM), powder X-ray diffraction (PXRD), and attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR).
  • Dissolution studies to evaluate drug release characteristics.

Main Results:

  • The model API-IL exhibited unlimited miscibility and solubility in water, unlike the parent ibuprofen API.
  • Stable API-IL/polymer microcapsules were successfully prepared via spray drying at high API-IL loadings.
  • The formulation mechanism involved polymer encapsulation of phase-separated API-IL due to polymer-API-IL immiscibility.
  • Spray drying did not negatively impact the dissolution characteristics of the API-IL.
  • Miscible API-IL/polymer systems at high loadings showed unfavorable physical properties, including melting point depression.

Conclusions:

  • Microencapsulated API-ILs in immiscible or low-miscibility polymers represent a promising platform for formulating poorly soluble compounds into oral solid dosage forms.
  • This approach enhances API-IL solubility while ensuring the formation of processable solid powders.
  • The strategy avoids the limitations of ASDs and offers thermodynamic stability upon release.