Enrobed tablet

Details Enrobed tablet Enrobed tablet

1995-02-21

2002-11-19

Le, H. Thi (Department: 1773)

Stock material or miscellaneous articles

Coated or structually defined flake, particle, cell, strand,...

Particulate matter

C424S451000, C424S456000, C424S463000, C424S478000, C424S490000, C424S492000, C424S501000, C428S403000, C428S407000

Reexamination Certificate

active

06482516

ABSTRACT:

FIELD OF THE INVENTION
This invention pertains to film-enrobed unitary-core products such as medicine tablets, to films and film compositions for making such products, and to methods and equipment for manufacturing such products. More specifically, within a presently preferred area of that field, the invention pertains to medicines and the like comprising cores of one-piece tablet nature in various geometrical forms which are enrobed in preferably digestible or erodable films applied to the cores separately from formation of the cores; the invention also pertains to gelatin-based and other films for enrobing such cores, to methods for enrobing such cores with such films, and to equipment for performing such methods to produce such products.
BACKGROUND OF THE INVENTION
The pharmaceutical, vitamin and related industries have long used various ways to present their products to users in swallowable oral dosage forms, other than purely as liquids, so that persons using such products can use them conveniently and comfortably. Broadly, orally used non-liquid medicines and the like are provided in two general forms. One form is a tablet in which the dosage unit is a solid, hard swallowable shape comprised of the desired active ingredients compressed and formed with suitable binders into an integral article. Tablets, in their broadest sense, are available in many shapes and sizes. The other common solid dosage is a capsule in which the active ingredients occur in a flowable state (powder, liquid, paste or the like) and are encased in a digestible shell of a suitable shape and form which is swallowable. Variations exist within and between these two general forms. Thus, it is known to coat, as by dipping or spraying, tablet-type dosage units with gelatin or other materials to make them more palatable, easier to swallow, less prone to powder or to flake when handled in bottles, colored for eye appeal or identifiability, and longer lasting before active ingredients degrade, among other reasons. Capsule forms of such products occur as soft gelatin capsules, which commonly are of spherical or oblate spherical shape, and as hard gelatin capsules which commonly are of elongated round-ended cylindrical form and which are made in two pieces for assembly, with or without sealing, around the flowable fill material containing the desired active ingredients.
The portion of U.S. Pat. No. 4,820,524 entitled “Back-ground of the Invention” (which portion is incorporated herein by reference) presents a comprehensive and good review of hard gelatin encapsulated medicines and the like, and of certain forms of solid medicaments having spray-applied or dip-applied gelatin coatings. That review is presented as an introduction to the invention of that patent which is a caplet (a tablet shaped to resemble a hard gelatin capsule) dipped first at one end and then at its other end in liquid gelatin to form, upon drying of the gelatin, a gelatin coating fully enclosing the preformed, base solid caplet. The text of that review notes that, because of the problem of tampering which had been experienced with hard gelatin capsule products, many manufacturers of such products withdrew them from the market in favor of other forms of active-ingredient presentment, notably caplets. The withdrawal of hard gelatin encapsulated products from the market left those manufacturers with idle machines for making hard gelatin capsules, a situation which U.S. Pat. No. 4,820,524 addressed by its descriptions of how such machinery could be modified to produce an at least twice-dipped, gelatin-coated caplet form of medicine. The resulting final product can be colored uniformly, or it can be colored differently at its opposite ends by differently tinting the gelatin baths into which each of the opposite ends of the caplet preform is dipped at least once. A number of advantages of such products over hollow hard gelatin capsules and over pan-coated tablets are noted in U.S. Pat. No. 4,820,524 at column 11, lines 19 et seq.
In its detailed description, namely, at column 10, lines 47 et seq., U.S. Pat. No. 4,820,524 notes that the dipping of preformed caplets into wet gelatin baths can have disadvantageous effects, and that precoating of the caplet with a sealant, such as a moisture barrier, can be useful.
While the procedures described in U.S. Pat. No. 4,820,524 for producing at least twice-dipped, gelatin-coated caplets are relatively simple, the machinery required for high-volume implementation of those procedures is quite complex, extensive and expensive. Also, those procedures and that machinery are not well suited for handling solid medicament preforms in shapes other than caplet shape.
In the context of soft gelatin capsules and the procedures and equipment for their manufacture, there have occurred descriptions of ways to produce approximations of gelatin coated tablets. The usual soft encapsulated gelatin product is one in which a flowable fill material (powder, paste or liquid) containing the desired active ingredient is pumped under pressure into place where two films of soft elastic gelatin are brought together between rotating or reciprocating dies with which the films are in contact. The dies have cavities formed in their surfaces. The pumping of fill material between the plastic gelatin films is carefully timed in synchronism with die movement so that a metered amount of fill is discharged between the films to cause the films to bulge into adjacent opposed die cavities. The films come together around a controlled amount of fill as the dies continue to move and the films are then sealed together by applying pressure and/or heat at the dies which then coact to cut the films at the seal. The then fully-enclosed-by-gelatin fill dosage quantity separates from the films as a discrete article. That article may then be washed to remove film lubricants (such as mineral oil) and then dried to provide the finished product which is suitably packaged for sale.
U.S. Pat. No. 2,663,128 (1953), U.S. Pat. No. 2,697,317 (1954), and U.S. Pat. No. 2,775,080 (1956), all issued to F. E. Stirin and A. S. Taylor as assignors to American Cyanamid Company, describe complex procedures and equipment in which a suitable active ingredient powder is formed into a soft pellet. The pellet is transferred by a vacuum holding mechanism into registry with and dispensed into a cup-like depression formed by vacuum in a plastic gelatin film. The cup-like depression can also contain a liquid. Thereafter, the film which defines the loaded depression is moved into contact with a second gelatin film which is sealed across the depression. The loaded and sealed depression is cut from the adhered pair of films, and the product then self-adjusts its shape to a desired tablet, sphere, or capsule-like shape, after which it is processed similarly to a conventional soft encapsulated gelatin capsule.
More recently (
Packaging Technology,
March/April 1987, Vol 17, No. 2, pp. 4, 7 and 16), equipment and methods for encasing a pair of half-dose softly-compacted tablet-like preforms between converging soft elastic gelatin films have been described. So far as is known, such equipment was not successfully built and operated.
These earlier descriptions of adaptations of soft elastic gelatin encapsulated tablet-like products in the Stirin et al patents and the
Packaging Technology
article teach that the tablet is formed as a soft preform and that such formation occurs in the same machinery which encloses the preform between two soft gelatin films. Such teaching is inconsistent with the actual development and present state of the industry which produces soft elastic gelatin capsules. That industry is based upon substantial investments of capital, time and human experience and is comprised of firms which are essentially packagers of products of others. Those firms either receive the flowable active-ingredient fill materials produced by others such as pharmaceutical manufacturers or vitamin compounders, or they formulate the fill material under the control of and in compliance with the

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