Orally Disintegrating Tablets

Abstract

The present invention describes a directly compressible composite prepared by co-processing a water-soluble excipient and calcium silicate. The present invention further describes the incorporation of the co-processed composite into a tablet formulation. The orally disintegrating tablets are of optimal mechanical strength and disintegrate within 60 seconds in the oral cavity.

Description

FIELD OF INVENTION[0001]The present invention provides a tablet with optimal mechanical strength, which when placed in the oral cavity rapidly dissolves or disintegrates without water preferably within about 60 seconds.[0002]More particularly, the present invention relates to composites produced by co-processing of at least one water-soluble excipient and at least one water insoluble excipient such as calcium silicate and their use in orally disintegrating tablets.BACKGROUND AND PRIOR ART[0003]Design of an orally disintegrating tablet requires a significant amount of research work in order to develop a process that maintains enough porosity inside the compressed tablets for fast dissolving or fast melting while maintaining the mechanical strength of the tablet. Orally disintegrating dosage forms are known in the art and some of the most commonly used techniques are incorporated herein by reference. Current technologies involved in many patents as well as existing commercial fast-dis...

AI Technical Summary

Benefits of technology

[0022]According to another aspect of the invention is provided an orally disintegrating tablet formulation having optimal mechanical strength comprising

[0025]c. At least one other excipient.such that the tablet has optimal mechanical strength and a disintegration time of about 60 sec in the oral cavity.

Problems solved by technology

However, the freeze-drying process suffers from several disadvantages, primary among these is that solutions employed for freeze-drying are aqueous and, therefore, not suited for water sensitive medicaments.

It is also limited to low dose actives.

The process itself is typically laborious, costly and time-consuming.

Finally, the resultant dosage forms, in addition to being hygroscopic, tend to be very soft and, therefore, require special moisture- and impact-resistant packaging and require careful handling.

However, such tablets have a chalky or dry feel when placed in the mouth.

Exposure of such tablet to moisture results in contact and chemical reaction between the effervescent couple which leads to gas production and tablet disintegration.

However, tablets which include effervescent pairs are highly sensitive to moisture and require a specific, very costly plant including special handling equipment, controlled-humidity environments and special moisture resistant packaging and also such preparations have an unpleasant mouth feel.

To counter this, a large amount of dispersing and distributing agent is included in the formulation which increases the weight of the tablet and also the cost of the formulation may increase.

The reduction in disintegration time with calcium silicate is more pronounced with immediate release tablets as tablets prepared with calcium silicate has low porosity leading to increased disintegration time in oral cavity.

However use of calcium silicate with conventional equipments leads to discoloration of the final dosage form due to interaction of calcium silicate with some metals.

Calcium silicate due to its hydrophobic and static nature results in blends with very poor flow properties causing weight and content variation during compression into tablets.

Further, it also imparts a chalky taste to the dosage form.

Majority of these techniques possess one or more of the above enumerated disadvantages to some extent such as tedious and complex method of manufacturing, special packaging and storage requirements, high cost, limitation on drug load etc.