Study on formulation and preparation technology of the composite cellulose-based enteric capsule shells

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Green Chemistry

Background:

• Traditional enteric capsule shells often involve organic solvents and complex multi-step processes.
• There is a growing demand for environmentally friendly and cost-effective pharmaceutical excipients.

Purpose of the Study:

• To develop a new formulation and technology for composite cellulose-based enteric capsule shells.
• To achieve capsule shell formation using a single-time dipping molding process without organic solvents.

Main Methods:

• Utilized Hydroxypropyl methylcellulose phthalate-55S (Hp55S) as the primary film-forming agent.
• Incorporated agar as a gelling agent and Hydroxypropyl methylcellulose (HPMC) as a disintegrating regulator.
• Developed a one-time dipping molding process involving dissolution, dispersion, mixing, and drying steps at controlled temperatures.

Main Results:

• The developed composite cellulose-based enteric capsule shells met the quality standards for 'enterosoluble vacant capsules' as per the Chinese Pharmacopeia.
• The formulation and process successfully eliminated the need for organic solvents.

Conclusions:

• The new plant-based enteric capsule shell offers an environmentally friendly alternative to traditional formulations.
• The simplified single-dip molding process reduces production steps, leading to lower manufacturing costs.
• This technology presents a sustainable and economically viable approach for producing enteric capsule shells.