JP3877232B2 - Caplet with gelatin cover and manufacturing method thereof - Google Patents

Description

[0001]
The present invention relates to drugs and processes for providing such drugs with gelatin coverage.
[0002]
Although drug delivery systems may be performed in the most diverse shapes and forms, the most common being compressed tabs LESSON bets coated in this, a caplet and filled gelatin capsules. Using gelatin capsules to wrap drugs has been a popular method for drug administration. This is because many patients prefer to encapsulate capsules and caplets rather than tablets.
[0003]
The caplet is a solid oval tablet that has been very popular as a means of drug delivery, but has not yet gained the same level of consumer acceptance as gelatin capsules once did. In order to solve this problem, the pharmaceutical industry has sought to combine the popularity of capsule-type consumers with caplets.
[0004]
Several proposals have been made and suggest that caplets are formed and subsequently coated to simulate capsule-like drugs. One such proposal is represented by US Pat. Nos. 5.089.270 and 5.22137.78 assigned to the current assignment. Other proposals are represented by US Patents 4.820.524, 4.928.840 and 5.146.730. Both of these proposals individually cover the first end of the caplet with half of the hard shell capsule, shrink the half of the capsule over the caplet and the other end of each caplet to the second. Cover with half of the hard shell capsule, shrink half of the capsule over the caplet, and form a caplet covered with gelatin without touching the half of the first shrink-wrapped capsule It is not intended to produce a capsule-like drug.
[0005]
The present invention comprises a solid core, such as caplets and thus, giving the drug a new imitation capsules covered by two halves of a hard shell gelatin capsule of the two shrink wrap. The solid core individually shrink wraps half of the first hard shell gelatin capsule over the first end of the core, and then half of the second hard shell gelatin capsule of the second core. Covered with half of a hard shell gelatin capsule by individually shrink wrapping over the edges. Half of the two shrink wrap capsules preferably border but do not overlap at about the midpoint of the longitudinal axis of the drug. If there is a gap between the two shrink-wrapped capsule halves, a caplet covered with a standard gelatin band is covered by lateral banding. In one embodiment, half of the two shrink-wrapped hard shell gelatin capsules can be of different colors to form a simulated two-color capsule.
[0006]
The basic components of current drugs are, for example, R.D., Troy, Michigan. P. Contains half of the first and second hard shell gelatin capsules as marketed by Sierra. This half diameter and length is chosen so that they do not slip together and the caliber drug caplet can fit into the half of the capsule. Half of the hard gelatin capsules can be any size from 4 to 000, and preferably half of the capsules containing differently colored gelatins make it easier to simulate the drug of the capsule.
[0007]
Pharmaceutical caplets are currently marketed, such as aspirin, acetaminophen (analgesic antipyretic), ibuprofen (anti-inflammatory). Or any of a number of prescription-based medications. Other known agents such as antihistamines and decongestants can also be included.
[0008]
The present invention provides a simulated gelatin capsule drug 10. As shown in FIGS. 1 and 2, drug 10 includes a caplet-shaped core 12 covered with a set of hard shell gelatin capsule halves 14 and 16. The capsule halves 14 and 16 have a combined length that is less than or equal to the length of the core 12. That is, when the capsule halves 14 and 16 are slid over the core 12, their ends are adjacent but not overlapping. The overlapping edges are also prevented from the capsule halves 14 and 16 having the same diameter. In the preferred embodiment, hard shell capsule halves 14 and 16, each having the same length, are placed on the core 12. In this embodiment, the annular ends of the capsule halves 14 and 16 are adjacent to each other at about the midpoint 11 of the longitudinal axis of the core 12.
[0009]
FIG. 3 is a schematic diagram showing a manufacturing sequence for manufacturing a caplet covered with a hard shell gelatin capsule of the shrink wrap of the present invention. With respect to the figure number, in the manufacturing process, the first end 13 of the core 12 is inserted into a holder (not shown) (block 30), leaving the second end 15 of the core 12 exposed. A small amount of liquid gelatin 19 is placed over the exposed second end 15 of the core 12 as shown in block 32. The half of the hard shell gelatin capsule 16 is then placed on the second end 15 of the core 12 and contacts a small amount of gelatin 19 (block 34) so that the shell remains in place on the core 12. Form a first half shell and core combination.
[0010]
The first combination is immersed in a warm water (90-95 ° C.) tank (not shown) for about 4 seconds to the annular end of the capsule half 16 (block 36) to hydrate the hard gelatin shell. And plasticize. A small amount of gelatin 19 is chosen to have a melting point greater than the temperature of the water so that the capsule half 16 can remain in place on the second end 15 of the core 12. After removal from the tank, the hard shell gelatin capsule half 16 is dried (block 38) and the hard shell gelatin capsule half 16 is shrunk to conform to the shape of the second end 15 of the core 12. A hard shell cover / core combination of shrink-wrapped gelatin can be formed, and is preferably formed. The first end 13 of the core 12 is then removed from the holder (block 40).
[0011]
The now covered second end of the first cover / core combination is then inserted into the holder (block 12) and a small amount of liquid gelatin 18 is placed over the exposed first end 13 of the core 12. Placed in. The hard shell gelatin capsule half 14 is then placed over the first end 13 of the core 12 (block 46) to contact a small amount 18 of gelatin, and the shell is held in place on the core 12 in the second position. Half of the shell / core combination. The second combination can be immersed in a hot water bath (block 48) and hydrated and plasticized. Like the small amount of gelatin 19, the small amount of gelatin 18 has a melting point higher than the temperature of water. The plasticized hard shell capsule half 14 dries (block 50) and shrinks to conform to the shape of the first end 13 of the core 12 to provide a second shrink wrap gelatin hard shell cover / core combination. Form. The cover / core combination is then removed from the holder (block 52).
[0012]
Examination of the drug after completion of the shrink wrapping process reveals that the two hard shell gelatin capsule halves 14 and 16 are substantially in intimate contact with the core 12. That is, it can be seen that the capsule halves 14 and 16 are shrink wrapped on the core 12. The capsule halves 14 and 16 as shown in FIG. 2 may sometimes not be adjacent near the midpoint of the longitudinal axis of the core. This is because when processing is complete, the capsule halves 14 and 16 contract and are pulled back several thousandths of each other in the middle of the core 12. If this happens, a standard barrel band 17 can be added to the core 12 to cover the gap between the capsule halves 14 and 16 and facilitate drug simulation of the gelatin capsule. .
[0013]
The length of time that the gelatin hard shell halves 14 and 16 are placed in the hot water tank to plasticize depends on the pigments in the capsule. For example, red pigment is the softest formulation and requires the shortest soaking time. Half of the white capsules, on the other hand, are hard formulations and require a relatively long soaking time. Half of the yellow and clear capsules require a soaking time between the soaking times required for the red and white capsules.
[0014]
The appropriate level of hydration required to plasticize a particular gelatin hard shell capsule can be determined by routine experimentation. To minimize processing difficulties, however, it is expected that the level of hydration should be as low as possible while leaving the capsule's ability to shrink when dried.
[0015]
Those skilled in the art of the present invention will appreciate that the foregoing description of the presently preferred embodiments of the various aspects of the invention is primarily exemplary and is not exhaustive of the manner in which the invention is embodied. Various amendments can be made to the above products, formulations, procedures and apparatus without departing from the scope of the invention as defined by the claims.
[Brief description of the drawings]
FIG. 1 is an exploded view of a dosage form covered by a hard shell gelatin capsule of shrink wrap of the present invention.
FIG. 2 is a cross-sectional view along the longitudinal axis of an alternative embodiment in the form of a dosage covered with a shrink-wrapped hard shell gelatin capsule of the present invention.
FIG. 3 is a schematic diagram of a sequence for producing a caplet covered with a shrink-wrapped hard shell gelatin capsule of the present invention.
[Explanation of symbols]
10 Drug 11 Intermediate point 12 Core 13 First end 14 Half of capsule 15 Second end 16 Half of rapcel 18 Small amount of gelatin 19 Small amount of gelatin

Claims (12)

In the simulated capsule drug,
(A) and a first end and a second end, and solid caplet having a substantially cylindrical shape,
( B ) half of a first hard shell gelatin capsule shrink-wrapped over the second end of the caplet;
It is shrink-wrapped onto the first end of (c) the caplet was simulated and is adjacent to the half of the gelatin capsule of the shrink-wrapped first rigid shell but not overlapping double Half of a second hard shell gelatin capsule forming a capsule-like drug;
(D) a medicament comprising a pharmaceutically acceptable adhesive between the end of the respective caplet and the adjacent inner surface of the first and second capsule halves .   2. A medicament according to claim 1, wherein half of the first and second shrink wrap capsules are adjacent at approximately the midpoint of the longitudinal axis of the medicament. The agent of claim 1, wherein the pharmaceutically acceptable adhesive is a small amount of gelatin. In the simulated capsule drug,
(A) and a first and second end, the solid caplet having a substantially cylindrical shape,
( B ) one half of a first hard shell gelatin capsule of a first color shrink-wrapped over the second end of the caplet;
(C) the different colors of the first color, is shrink wrapped over the said first end of said caplet, a half and the agent of the gelatin capsules of the first rigid shell which is the shrink wrapped Half of a second hard shell gelatin capsule forming a simulated capsule-like drug adjacent but non-overlapping at about the midpoint of the longitudinal axis;
(D) a medicament comprising a pharmaceutically acceptable adhesive between the end of the respective caplet and the adjacent inner surface of the first and second capsule halves .   5. A drug according to claim 4, wherein half of the first gelatin capsule is red.   5. The drug according to claim 4, wherein half of the second gelatin capsule is white.   5. The medicament of claim 4, wherein the caplet has a width and a length, and the length is at least 2.5 times the width. 5. The agent of claim 4, wherein the pharmaceutically acceptable adhesive is a small amount of gelatin. In a method for producing a simulated capsule drug by covering a caplet with half of a hard shell gelatin capsule,
(A) providing the caplet with first holding means and second holding means;
(B) inserting the first end of the caplet into the first caplet holding means while the second end of the caplet remains exposed;
(C) placing half of the hard shell gelatin capsule on the second exposed end of the caplet;
(D) immersing a second exposed end of the caplet covered with the hard shell capsule in a hot water bath to plasticize half of the hard shell capsule;
(E) drying half of the plasticized hard shell capsule to form a second end covered with the hard shell of the shrink wrap;
(F) removing the caplet from the first holding means;
(G) Inserting the second end of the caplet covered by the hard shell capsule into the second caplet holding means, leaving the first end of the caplet exposed. When,
(H) placing one half of the hard shell gelatin capsule on the end of the first exposed caplet;
(I) immersing the first exposed end of the caplet covered with the hard shell capsule in a hot water bath to plasticize half of the hard shell capsule;
(J) drying one half of the plasticized hard shell capsule to form a first end covered with the hard shell of the shrink wrap; the shrinking over the first and second ends; The half cover of the hard shelled shell gelatin capsule covers the caplet;
(K) removing the caplet from the second holding means. 10. The method of claim 9, wherein steps ( c ) and ( i ) cover the first and second ends of the caplet with half of a different color hard shell gelatin capsule. . 10. The method of claim 9, wherein the first holding means is selected to include holding means for keeping the caplet in the correct position during at least step ( c ). 9. The method of claim 9, wherein the first and second of the caplet are placed before the half of the hard shell gelatin capsule is placed on the first and second exposed ends of the caplet. Applying the pharmaceutically acceptable adhesive to the exposed edges further .

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