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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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Conventional oral drug products, termed immediate-release (IR) formulations, are engineered to promptly release their active pharmaceutical ingredient (API) upon ingestion, typically in tablets or capsules. This rapid release often results in swift drug absorption and consequent pharmacodynamic effects, although the timing and intensity can vary depending on the drug's properties. Prodrugs within these formulations require metabolic conversion to activate their pharmacodynamic effects,...
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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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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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Oral drug delivery is the most common route of administration due to its convenience, cost-effectiveness, and high patient compliance. It enables precise formulation to ensure proper drug dosage and bioavailability. The development of oral dosage forms considers drug properties such as solubility, stability, and absorption to optimize therapeutic efficacy.Tablets, capsules, liquids, and chewable formulations enhance drug stability, mask undesirable tastes, and improve patient experience.
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In Vitro Drug Dissolution: Compendial Testing Models I01:13

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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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Evaluation of disintegrants functionality for orodispersible mini tablets.

Ian Soulairol1,2, Mohammad Chaheen1,3, Nicolas Tarlier1

  • 1a UMR 5253, Equipe MACS, ICGM, University of Montpellier , Montpellier , France.

Drug Development and Industrial Pharmacy
|June 6, 2017
PubMed
Summary

Cross-linked poly (vinyl pyrrolidone) effectively reduced disintegration time in orodispersible mini tablets (ODMT). Current in vitro tests do not accurately predict in vivo performance for ODMT.

Keywords:
Orodispersible mini tabletdisintegration timemini tablet characterizationsuperdisintegrantstabletability

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Formulation Science

Background:

  • Orodispersible mini tablets (ODMT) offer advantages in drug administration.
  • Superdisintegrants (SD) are crucial for rapid tablet disintegration.
  • Optimizing SD selection is key for effective ODMT manufacturing via direct compression.

Purpose of the Study:

  • To evaluate the performance of various superdisintegrants (SD) in manufacturing orodispersible mini tablets (ODMT) using direct compression.
  • To assess the impact of SD type and concentration on ODMT properties and disintegration time (DT).

Main Methods:

  • Manufactured 23 ODMT formulations with varying SD types, concentrations, and lubricants.
  • Characterized ODMT for friability, porosity, tensile strength, and both in vivo and in vitro disintegration time (DT).

Main Results:

  • Superdisintegrant type and concentration did not affect tablet friability, porosity, or tensile strength.
  • Only cross-linked poly (vinyl pyrrolidone) consistently improved in vivo DT.
  • Microcrystalline cellulose (MCC) content above 20% increased DT; cross-linked carboxymethyl cellulose accelerated DT with <20% MCC.
  • In vitro DT was consistently shorter than in vivo DT, with no observed correlation.

Conclusions:

  • A need exists for improved in vitro disintegration tests that accurately simulate in vivo conditions for ODMT.
  • Standardization of test methods for ODMT requires a better understanding of superdisintegrant mechanisms.