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Fragmenting Bulk Hydrogels and Processing into Granular Hydrogels for Biomedical Applications

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A new methodology for high drug loading wet granulation formulation development.

Lixia Cai¹, Leon Farber, Dina Zhang

¹Pharmaceutical Sciences and Clinical Supply, MRL, Merck Sharp & Dohme, Inc., 770 Somneytown Pike, West Point, PA 19486, USA. lixia_cai@merck.com

International Journal of Pharmaceutics

|October 13, 2012

Summary

A new method efficiently develops high drug load (>85%) wet granulation formulations. This approach minimizes excipient use, ensuring satisfactory product attributes for diverse active pharmaceutical ingredients (APIs).

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Area of Science:

Pharmaceutical Sciences
Formulation Development
Process Engineering

Background:

Developing high drug load formulations (>85%) presents significant challenges in pharmaceutical manufacturing.
Traditional methods often require extensive excipient use, increasing complexity and cost.
Optimizing granulation processes for diverse active pharmaceutical ingredients (APIs) is crucial for efficient drug delivery.

Purpose of the Study:

To introduce and validate a novel methodology for the efficient and rapid development of high drug load (>85%) high shear wet granulation formulations.
To investigate the correlations between API properties, binder types, granulation fluid levels, and resulting product attributes.
To demonstrate the applicability of the methodology across different APIs with varying physicochemical properties.

Main Methods:

A systematic study correlating API properties (particle size, wettability, solubility) with granulation outcomes.
Utilized three model APIs: simvastatin, etoricoxib, and metformin hydrochloride.
Characterized granules for size distribution, strength, flowability, dissolution, and compactibility; tablets were compressed and evaluated; one formulation underwent in vivo pharmacokinetic (PK) study.

Main Results:

The proposed methodology successfully developed high drug load formulations with satisfactory attributes for all three model compounds.
Established key correlations between formulation components, process parameters, and critical quality attributes.
Demonstrated that excipients are only added when necessary, streamlining the formulation process.

Conclusions:

The developed methodology enables efficient and rapid creation of high drug load wet granulation formulations.
The approach is versatile and applicable to APIs with diverse physicochemical characteristics.
This strategy offers significant benefits in terms of process efficiency and formulation optimization.