Chewable soft capsule

Details Chewable soft capsule Chewable soft capsule

1999-03-05

2001-07-10

Page, Thurman K. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Capsules

C424S451000, C424S455000

Reexamination Certificate

active

06258380

ABSTRACT:

BACKGROUND OF THE INVENTION
(1) Field of the Invention
The present invention relates generally to soft gelatin capsules and to a process for their preparation, and in particular to soft gelatin capsules having a chewable consistency.
(2) Description of the Prior Art
Soft gelatin capsules are comprised of a gelatin sheath encapsulating a fill of a medicament, vitamin, or other material to be consumed by the user. The one-piece gelatin sheath or shell includes a plasticizer, normally glycerin or sorbitol, to control the softness and flexibility of the sheath. The sheath also includes water, and optionally, other additives, such as flavorants. The fill is normally comprised of a carrier in which the active material is dissolved or suspended.
Chewable soft gelatin capsules, or chewable softgels, are designed so that the user chews upon the capsule to release the fill into the mouth instead of swallowing the capsule with the fill still encapsulated within the sheath. Chewable capsules are particularly suitable for administering analgesics, vitamins, minerals and cold remedies. After the fill has been released, the user chews the fractured sheath until it is partially or completely dispersed. In an alternative embodiment described in U.S. Pat. No. 4,428,927, a chewing gum base material is incorporated into the sheath and the sheath is not made for swallowing.
Therefore, acceptable sheath formulations must not only have sufficient integrity to encapsulate the fill without leakage prior to consumption, they must also be readily soluble or dispersible when chewed. In addition, the formulations must not be of a sticky or tacky nature during processing, interfering with the conversion of the gelatin mass into sheaths in conventional encapsulation equipment.
While an effective delivery system, the acceptance of chewable softgels has been limited by the mouth-feel or texture of the sheath, which is commonly perceived to be leathery or rubbery, and the difficulty in consuming the fractured sheaths after the fill has been released. The use of chewable softgels could be significantly expanded if this problem could be overcome.
SUMMARY OF THE INVENTION
The present invention is directed to chewable soft gelatin capsules, or chewable softgels comprised of a chewable gelatin sheath encapsulating a liquid fill. The sheath composition is specifically characterized by flexibility and a non-sticky consistency so that it can be formed into capsules using conventional encapsulation machinery, and the integrity to enclose a fill for an extended period of time, e.g., up to about two years, without dissolution or leakage, while still being readily soluble upon consumption.
Most conventional softgel capsules are produced by a rotary die process in which a molten mass of a gelatin sheath formulation is fed from a reservoir onto drums to form two spaced sheets or ribbons of gelatin in a semi-molten state. These ribbons are fed around rollers and brought together at a convergent angle into the nip of a pair of roller dies that include opposed die cavities. A liquid or paste medicament or other material to be encapsulated is fed into the wedge-shaped joiner of the ribbons.
The gelatin ribbons are continuously conveyed between the dies, with portions of the medicament being trapped between the sheets inside the die cavities. The sheets are then pressed together, and severed around each die so that opposed edges of the sheets flow together to form a continuous gelatin sheath around the entrapped medicament. The part of the gelatin sheet that is severed from the segments forming the capsules is then collected for recycling. The very soft capsules are then dried to increase the integrity of the sheath, and packaged for later distribution and consumption.
Manufacture of uniform soft gelatin capsules by this or similar processes requires a sheath material that has good “machineability,” i.e., it is of critical importance that the sheath material be of a non-tacky or non-sticky nature, so that the sheath material can be brought into contact with the rollers without sticking. At the same time, the sheath composition must not degrade or dissolve during storage prior to consumption, allowing the fill material to leak from the capsule.
The properties of the sheath material is determined in significant part by the cohesive strength of the constituent gelatin, expressed as “bloom.” Conventional soft gelatin capsules normally have a bloom in the range of from about 150 to about 275. This bloom value is determined by measuring the weight in grams required to move a plunger 0.5 inch in diameter, 4 mm into a 6.67% gelatin gel that has been held for 17 hours at 10° C.
Chewable softgel capsule sheaths are designed to at least partially disperse or dissolve in the user's mouth within a brief period of time after the fill contents have been released, e.g., within about 60 seconds, so that it can be swallowed. Therefore, in addition to the above properties, the sheath of these products must also be soluble after the fill contents are released. The sheath should also have a good “mouth feel.” As used herein, “mouth feel” describes chewability. Chewing the sheath should be a pleasant, or at least not an unpleasant sensation that results in a swallowable composition.
Surprisingly, it has been found that a chewable softgel sheath having all of these desired characteristics can be produced from a specific mixture of defined gelatins in combination with defined percentages of a plasticizer and preferably a moisture retaining agent. This combination of ingredients, to be described herein in detail, has been found to produce capsule sheaths that have the necessary low stickiness for machineability, and sufficient integrity for stable fill encapsulation, while having a desirable mouth-feel and solubility.
More specifically, the present capsule sheaths are formed of a mixture of a first gelatin having a bloom substantially lower than the bloom of gelatins conventionally used to form capsule sheaths, in combination with a minor percentage of a second gelatin having a bloom within the range of conventional sheath-forming gelatin blooms. The first gelatin has insufficient integrity for use alone in sheath formation.
Plasticizers are essential in sheath formulations in order to impart the necessary softness and flexibility to the sheath material, so it can be formed into capsules. The presence of a significant percentage of plasticizer, however, may result in a sheath that is difficult to process because the sheath will stick to the rollers during machining, as described herein above. Also, the plasticizers tend to dry out the sheath over any extended shelf-life of the finished product capsule, resulting in a capsule with a “leathery” mouth feel.
In accordance with an additional embodiment of the present invention, the tackiness or stickiness of the sheath can be maintained at a desired machinable level, even in the presence of high percentages of plasticizers, by adding a small percentage of a moisture retention agent, as hereafter defined, to the sheath composition. The moisture retention agent also maintains the desired mouth feel over an extended shelf-life.
While the function of the moisture retention agent is not entirely clear, it appears that the additive disrupts the gelatin structure to reduce the gelatin strength and immobilizes or retains water.
More specifically, the present sheath composition is comprised of a first gelatin, hereinafter referred to as “low bloom” gelatin, having a bloom of up to about 100, and preferably from about 80 to about 100. The low bloom gelatin is combined with a second gelatin, hereinafter referred to as “medium bloom” gelatin, having a bloom in the range of from about 150 to about 275, and preferably from about 150 to about 175. The first and second gelatins preferably are present in a ratio of from about 1:1 to about 10:1, and even more preferably a ratio of from about 3:1 to about 5:1. Type A or B gelatins or a mixture thereof, may be used for the first and/or the second gelatin. Limed bone, acid

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