Abstract
Robust and inert, spherical carriers are a prerequisite for the manufacture of multi-particulate dosage forms.
In this study, spheres composed of microcrystalline cellulose (VIVAPUR MCC SPHERES) were compared with sugar spheres.
The spheres were evaluated in terms of their mechanical robustness and ease of drug-layering and coating, as well as the finished product's gastro- resistance and dissolution behavior. VIVAPUR MCC SPHERES exhibited an overall superior performance compared to equally sized sugar spheres.
Introduction
Many active ingredients must be administered in a gastro-resistant form in order to protect the stomach against irritating properties of the active ingredient, or -vice versa to protect the active ingredient against the acidic conditions in the stomach.
Gastro-resistance can easily be achieved using coating materials which are insoluble in the acidic cfondition of the stomach and soluble in the closer-to-neutral pH of the intestines.
As opposed to conventionally coated tablets, multi-particulate systems contain the active ingredient in a subdivided form. Each of the individual units carries its own functional coating and acts as an independent modified release system.
Although multi-particulate systems are technically more demanding than monolithic tablets, there are some substantial advantages, which explain the wide acceptance of multi-particulate systems in the health science industry. Diving the total API dose into individually coated subunits reduces the risk of immediate and uncontrolled release oft he API in the case of a single coating defect. Multi-particulate systems, therefore, improve the safety of dosage forms.
Robust and inert, spherical carriers are a prerequisite for the manufacture of multi-particulate dosage forms.
In this study, spheres composed of microcrystalline cellulose (VIVAPUR MCC SPHERES) were compared with sugar spheres.
The spheres were evaluated in terms of their mechanical robustness and ease of drug-layering and coating, as well as the finished product's gastro- resistance and dissolution behavior. VIVAPUR MCC SPHERES exhibited an overall superior performance compared to equally sized sugar spheres.
Introduction
Many active ingredients must be administered in a gastro-resistant form in order to protect the stomach against irritating properties of the active ingredient, or -vice versa to protect the active ingredient against the acidic conditions in the stomach.
Gastro-resistance can easily be achieved using coating materials which are insoluble in the acidic cfondition of the stomach and soluble in the closer-to-neutral pH of the intestines.
As opposed to conventionally coated tablets, multi-particulate systems contain the active ingredient in a subdivided form. Each of the individual units carries its own functional coating and acts as an independent modified release system.
Although multi-particulate systems are technically more demanding than monolithic tablets, there are some substantial advantages, which explain the wide acceptance of multi-particulate systems in the health science industry. Diving the total API dose into individually coated subunits reduces the risk of immediate and uncontrolled release oft he API in the case of a single coating defect. Multi-particulate systems, therefore, improve the safety of dosage forms.