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Gastroresistant capsular device prepared by injection molding.

Lucia Zema1, Giulia Loreti, Alice Melocchi

  • 1Dipartimento di Scienze Farmaceutiche, Università degli Studi di Milano, via G Colombo 71, 20133 Milano, Italy.

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Manufacturing gastro-resistant capsules using injection molding (IM) with hydroxypropyl methyl cellulose acetate succinate (HPMCAS) is feasible. Formulation optimization enhanced stability and dissolution, offering an alternative to coated dosage forms.

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science

Background:

  • Coated dosage forms are common, but alternatives are sought.
  • Hydroxypropyl methyl cellulose acetate succinate (HPMCAS) offers potential for gastro-resistant devices.

Purpose of the Study:

  • Investigate the injection molding (IM) of HPMCAS for gastro-resistant capsular devices.
  • Develop an alternative to traditional coated dosage forms.

Main Methods:

  • Evaluated HPMCAS processability with polyethylene glycol 1500 plasticizer.
  • Conducted formulation studies with release modifiers (Kollicoat® IR, Explotab® CLV).
  • Assessed physical/mechanical stability and dissolution profiles at different pH levels.

Main Results:

  • Successfully manufactured capsule prototypes (600 and 900 μm thickness) via IM.
  • Achieved gastric resistance in pH 1.2 and rapid break-up in pH 6.8 within 1 hour.
  • Identified formulation strategies to overcome initial shrinkage and warpage issues.

Conclusions:

  • Injection molding of HPMCAS is a viable method for producing gastro-resistant capsules.
  • Optimized formulations demonstrate promising performance for enteric delivery.
  • The developed process supports the design of scalable manufacturing for novel dosage forms.