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Enteric spherules diastase in enzyme preparations.
1Pharmaceutics Laboratory, Department of Pharmaceutical Sciences, Sagar, India.
Journal of Microencapsulation
|October 1, 1991
Summary
New enteric diastase spherules were developed for improved digestive enzyme delivery. Eudragit RS-100 based formulations demonstrated enhanced stability and controlled release, showing significant therapeutic potential.
Area of Science:
- Pharmaceutical Sciences
- Biochemistry
Background:
- Digestive enzyme therapy requires stable formulations with controlled release.
- Enteric delivery systems are crucial for protecting enzymes from gastric degradation.
Purpose of the Study:
- To develop and characterize enteric diastase spherules using cellulose acetate phthalate and Eudragit RS-100.
- To investigate factors influencing spherule properties and diastatic activity.
- To evaluate the stability and efficacy of the prepared spherules.
Main Methods:
- Emulsion solvent removal method for spherule preparation.
- Systematic study of pH, temperature, and surfactant concentration effects.
- In vitro and in situ testing for stability and diastatic activity in various buffer systems and presence of pepsin.
Main Results:
- Eudragit RS-100 based spherules were spherical, uniform, and exhibited good diastatic activity.
- Slow and controlled release of diastase was observed from Eudragit RS-100 systems.
- Eudragit RS-100 provided superior stabilization compared to cellulose acetate phthalate.
- Spherules maintained 99% potency in in vitro and in situ tests.
Conclusions:
- Enteric, pH-sensitive diastase-releasing systems show significant promise for therapeutic applications.
- Eudragit RS-100 is a suitable material for developing stable and effective enteric diastase delivery systems.
- Controlled release of digestive enzymes can be achieved through advanced formulation strategies.