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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: 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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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 Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

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In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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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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Drug Product Performance: In Vitro–In Vivo Correlation01:20

Drug Product Performance: In Vitro–In Vivo Correlation

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In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while...
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In Vitro-In Silico Tools for Streamlined Development of Acalabrutinib Amorphous Solid Dispersion Tablets.

Deanna M Mudie1, Aaron M Stewart1, Jesus A Rosales1

  • 1Global Research & Development, Lonza, Bend, OR 97703, USA.

Pharmaceutics
|August 28, 2021
PubMed
Summary
This summary is machine-generated.

Developing amorphous solid dispersions (ASDs) for poorly soluble drugs like acalabrutinib can be streamlined. This study used in vitro and in silico methods to efficiently create high-performing ASD tablets, reducing development time and cost.

Keywords:
GastroPlusabsorption modelingacalabrutinibacid reducing agentamorphous solid dispersionbioavailability enhancementin silico predictionkinase inhibitorproton pump inhibitorspray drying

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Formulation Development

Background:

  • Amorphous solid dispersions (ASDs) enhance oral bioavailability for poorly water-soluble drugs.
  • Developing robust ASDs is often complex, time-consuming, and expensive.
  • Acalabrutinib exhibits a pH-dependent solubility, posing formulation challenges.

Purpose of the Study:

  • To describe a streamlined in vitro and in silico approach for developing acalabrutinib ASD tablets.
  • To overcome the pH effect observed with commercially available acalabrutinib formulations.
  • To reduce the time and cost associated with ASD drug product development.

Main Methods:

  • Screening of hydroxypropyl methylcellulose acetate succinate (HPMCAS) polymer grades (H and M) for drug supersaturation sustainment.
  • Gastric to intestinal transfer dissolution tests at elevated gastric pH to assess in vitro performance.
  • In silico simulations using a bottom-up approach to predict in vivo study outcomes.

Main Results:

  • HPMCAS-H and -M grades demonstrated prolonged acalabrutinib supersaturation.
  • HPMCAS-H grade ASD tablets exhibited the highest in vitro area under the curve (AUC) at elevated gastric pH.
  • In silico models accurately predicted in vivo study results (average fold error of AUC₀-inf < 2).

Conclusions:

  • A streamlined approach combining drug, polymer, and physiological understanding with in vitro/in silico tools can efficiently develop ASDs.
  • This method successfully mitigated the pH effect for acalabrutinib without reformulation.
  • The integrated approach shows potential for accelerating ASD development, reducing costs and timelines.