This invention relates to chewable capsules having improved acceptability for the consumer.
Soft gelatin capsules are a well established means for providing a variety of liquid products such as drugs or dietary supplements in a relatively digestible form.
EP 0211079 discloses a partitioned soft capsule in which a rapidly soluble film is used to form both parts of a capsule. The capsule is able to deliver two separate liquid compositions which are contained within separate but adjacent reservoirs in the capsule to the mouth. The capsules of this patent suffer the disadvantage that they are not easy to grip between the teeth when chewing and are thus prone to xe2x80x9cpopping outxe2x80x9d from between the teeth as the patient bites the capsule. In addition, it is necessary to form the capsule from at least three separately fed sheets of material thereby increasing the complexity of manufacture and hence the cost per capsule.
When chewable capsules are chewed or bitten (rather than swallowed), they release their contents into the mouth. This may be particularly advantageous when the capsule contents have a topical effect in the mouth or throat or when the liquid fill provides a soothing or coating effect. Delivering liquids by this means is particularly useful when bulk doses of liquid medicaments are not convenient (e.g. because of frequent or irregular dosing patterns or when measuring doses accurately is not convenient).
Chewable capsules may also be particularly advantageous when the patient is unable or unwilling to swallow solid dosage forms (e.g. tablets or hard capsules) e.g. because of age, throat pain/constriction etc.
The full commercial development of such chewable dosage forms has however been hindered by two particular drawbacks.
Firstly, for capsules above a volume of approximately 0.5 ml, when the capsule is bitten the resulting burst of contents is aesthetically unpleasant, indeed it has been likened to xe2x80x9cbiting an eyeballxe2x80x9d. To overcome this drawback it has been suggested that the fill volume of the capsules should be reduced, but this is not always practical. To reduce the fill volume whilst delivering the same drug dosage the fill must be more concentrated, which in most cases means more viscous. Increasing viscosity leads to difficulty in filling the capsules accurately (as the fill must be pumped through narrow dosing tubes) and consequent unacceptable dose variations. Also small capsules are difficult to locate between the teeth and are therefore difficult to break open.
A second disadvantage of conventional chewable capsules is that many active materials or excipients are incompatible with each other when combined in a liquid fill. This incompatibility may be due to reactions between two or more components of the liquid fill, leading to e.g. degradation of one or more of the active materials, or the release of gases which cause the capsules to burst. This means that for many combinations of active, materials and or excipients it is necessary to provide two or more different capsules each time a dose is taken; increasing the risk of confusion of the patient and poor compliance with the correct dosing schedule.
There is thus a need for a chewable capsule which is capable of delivering one or more liquid compositions to the mouth without the unpleasant sensation of the contents spurting out that occurs when a conventional capsule is bitten. It is also desirable for the chewable capsule to be suitable for delivering two or more incompatible liquid formulations to the patient via a single oral dosage form. Ideally, the chewable capsules should have a simple construction and be inexpensive to manufacture. The present invention aims to provide a chewable capsule satisfying the above aims and having a mouth feel which is acceptable to the patient.
According to the present invention there is provided a chewable oral unit dosage for releasing liquid in the mouth, comprising a soft ingestible substrate which includes a plurality of spatially-separated reservoirs, wherein each reservoir is adapted to retain liquid fills, preferably discrete liquid fills, and wherein the release of the liquid fills from the reservoirs occurs in a controlled manner when he unit dosage is chewed.
Preferably the oral unit dosage is a capsule, more preferably a gelatin capsule.
USPTO Backgrounds
USPTO Backgrounds