The present invention relates to a press-fit fast release caplet having gelatin covered ends leaving an uncovered center band.
Gelatin covered caplets have become a popular dosage form for medicaments and provide tamper-resistant safety as well as easy swallowability. Several methods have evolved for the gelatin covering of caplets, including the dip-coating of caplets with a gelatin solution, the encapsulating of gelatin capsules utilizing an encapsulation machine and process as disclosed in U.S. Pat. No. 6,209,296 and in copending U.S. patent application Ser. No. 10/899,924, filed on Jul. 27, 2004, entitled TABLET ENCAPSULATING MACHINE. Also, caplets have been employed in which gelatin shells are hydrated and subsequently shrink-fitted onto a caplet to provide a caplet core which is fully enclosed by gelatin capsule shells. U.S. Pat. Nos. 5,415,868 and 5,824,338 are examples of such dosage forms.
In order for a medicament to enter the bloodstream of a patient, it is necessary for the gelatin covering of gelatin covered medicaments to dissolve, typically in the stomach, which takes a certain period of time before the medicament can effectively be assimilated by the person's body. Although uncoated medicaments are faster acting, they tend to be less easily swallowed than medicaments having a gelatin covering.
It would be desirable, therefore, to provide a medicament which has the ease of swallowability of a gelatin-covered caplet and yet the relatively rapid release of medicament as in uncoated caplets.
The medicament of the present invention and its method of manufacture solves this need by providing a medicament core which contains a super disintegrant or an effervescent couple including a foaming agent and a pharmaceutically acceptable acid activator, which core is partially covered by a gelatin covering such that at least a part of the core is exposed for activation upon exposure to bodily fluids.
In the preferred embodiment of the invention, the medicament core is a caplet shaped core with gelatin capsule shells press-fit from opposite ends thereof, leaving a gap exposing the core between the facing ends of the gelatin capsule shells. Also in the preferred embodiment of the invention, the gelatin capsule shells are press-fit onto opposite ends of the caplet core, leaving a gap of from about 3 to about 4 mm between the facing ends of the gelatin capsule shells. The medicament, therefore, provides a gelatin covering for at least part of the medicament and an exposed core which causes the caplet to split and rapidly dissolve to release its active ingredients before the gelatin dissolves, resulting in a quick accessibility of the medicament to the patient.
These and other features, objects and advantages of the present invention will become apparent upon reading the following description thereof together with reference to the accompanying drawings.
Referring initially to
In one embodiment of the invention, the core 12 had an overall length of about 0.85 inches, with each capsule shell 14 and 16 having a length indicated by dimensions A and B in
The core, as shown in
The thickness of the capsule shells 14 and 16 is conventional. Shells 14 and 16 are subsequently press-fit onto the core 12 as illustrated by step 26 in
The exact dimensions of the caplet and gelatin capsule shells can be varied as long as they interfit with one another to press-fit or otherwise attach the capsule shell halves to the core in such a manner as the core includes an exposed area. Further, the medicament can be manufactured with an elongated capsule shell which leaves one end of the medicament exposed as opposed to a center band, although the center band is preferred. Further, other shapes of tablet cores may be employed with a suitable gelatin covering which exposes a sufficient surface area of the medicament such that the super disintegrant or effervescent couple will effectively release the active ingredients into the body more quickly than an entirely gelatin covered medicament. Also, capsule shell halves 14 and 16 can be made of materials other than gelatin. Such materials include inter alia polyvinyl alcohol, starches, alginates, acrylates, polyvinyl pyrrolidone, cellulose derivates, and polysiloxanes.
Referring now to
It will become apparent to those skilled in the art that various modifications to the preferred embodiments of the invention as described herein can be made without departing from the spirit or scope of the invention as defined by the appended claims.
This application claims priority under 35 U.S.C. § 119(e) on U.S. Provisional Application No. 60/609,313 entitled QUICK DISSOLVE CAPSULE AND METHOD OF MANUFACTURING, filed on Sep. 13, 2004, by Ronald L. Perry et al., the entire disclosure of which is incorporated herein by reference.
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/US05/31962 | 9/8/2005 | WO | 00 | 3/12/2007 |
Number | Date | Country | |
---|---|---|---|
60609313 | Sep 2004 | US |