Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
2000-08-21
2002-08-06
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S452000, C424S458000, C424S464000, C424S489000
Reexamination Certificate
active
06428808
ABSTRACT:
This invention relates to flavouring systems, particularly for flavouring orally administered pharmaceutical formulations.
Pharmaceutical formulations for oral administration are often provided in a made up liquid form ready for dispensing by a chemist or pharmacist and consumption by the patient without dilution. Alternatively such formulations are provided in a concentrated liquid form for reconstitution with a convenient volume of water or other palatable aqueous medium just prior to ingestion. Further alternative formulations may be in the form of a dry powder or granules suitable for reconstitution. Many examples of such formulations are known in the art. The active constituents of such formulations and/or the excipients sometimes have an unpleasant taste, and therefore a flavouring material is usually included in such formulations. This is particularly the case with paediatric formulations.
A problem arises in that preferences for the taste of such flavourings often varies between patients or groups of patients, such as patients of different nationalities with local taste preferences. For example a flavour which may be acceptable or preferred in one country may be less acceptable in another country, or one flavour may be unacceptable to individual paediatric patients whilst a different flavour may be preferred. Also the problem of “flavour fatigue” may be experienced, in that a patient may become tired of repeated doses of the same, albeit pleasant, flavoured medicament Normally pharmaceutical formulations are made up as a bulk including the flavouring material. Consequently any need to prepare alternative flavoured formulations requires preparation of separate bulk quantities of flavoured formulation, and the possibility of suiting differing individual preferences for flavours is limited. In addition, flavours are normally provided in the form of intensely flavoured materials which cannot be conveniently handled by individual patients in the small quantities in which they are present in an individual supply or dose.
It is therefore desirable to provide a method by means of which unit or individual dosages or other small quantities of oral formulations can be easily and individually flavoured. In particular in the case of paediatric formulations it is also desirable to provide any flavouring system in an attractive and appealing form.
In a first aspect the present invention provides a method for preparing a flavoured liquid medicament which comprises addition of a flavouring vehicle to a medicament.
By the term “flavouring vehicle” is meant any suitable flavouring means capable of releasing flavouring into a liquid medicament, including dosage means such a tablet or a capsule containing an aliquot of powder or liquid containing a pharmaceutically acceptable flavouring substance. Alternatively, the flavouring vehicle can be a flavouring substance per se, either in neat form, or preferably in the presence of a pharmaceutically acceptable carrier or excipient. Preferably the flavouring vehicle is an aliquot of powder or liquid containing a pharmaceutically acceptable flavouring substance which is added to the unflavoured medicament, said flavouring being initially contained in a capsule or sachet.
Other flavouring vehicles within the scope of the invention include a flavour impregnated package, for example a bottle having a lid impregnated with flavouring. The bottle is of a suitable size for a course of treatment and the patient can select from lids having alternative impregnated flavours. Further alternatives are oral syringes or dosing cups impregnated with flavouring.
A further flavouring vehicle within the scope of the invention comprises an edible solid substrate in the form of a wafer or thin sheet of a water-dispersible or water-soluble non-toxic material which dissolves and/or disperses in an aqueous media. The wafer has a sufficient quantity of an edible flavouring substance impregnated in or deposited on its surface, such that the flavouring substance passes into the aqueous medium on dissolution or dispersion of the substrate therein and imparts a palatable flavour to the liquid material.
Preferably the flavouring vehicle is a capsule or sachet each of which contains an aliquot of liquid or powdered flavouring. Other preferred flavouring vehicles are tablets or flavoured wafers. More preferably the flavouring vehicle is a sachet or a capsule. Most preferably the flavouring vehicle is a sachet or a capsule containing a liquid flavouring formulation which is the added to the liquid medicament, i.e. the contents of the capsule or sachet are added.
By the term “capsule” is meant any receptacle capable of containing a flavouring. The flavouring within the capsule can be an aliquot of liquid or powder, preferably the capsule will contain the flavouring in liquid form. Such capsules can be manufactured from any suitable synthetic or natural material, for example polyethylene or gelatin. In the case of capsules which are to be added to the medicament, the capsule shell is preferably made of a substance which is readily soluble in water or aqueous media, for example starch. Alternative capsules, which are preferred, are those which can contain an aliquot of powder or liquid and can be opened by the patient or pharmacist and the contents then added to the formulation. Such capsules include those having a frangible portion, for example ampoules and the like. The advantage of this type of capsule is that there is no time delay while the capsule shell dissolves.
By the term “sachet” is meant any packet capable of containing a flavouring. The sachet can be made of any suitable material including paper, plastic or foil so that it can be opened by the patient or pharmacist and the contents then added to the formulation.
By the term “liquid medicament” is meant a formulation comprising a drug substance in liquid form, for example a solution, suspension, emulsion or syrup. The liquid medicament can be any pharmaceutical formulation which is in solution, suspension, emulsion or syrup form, including formulations which have been made up as described above by reconstitution of a concentrate. The flavouring substance dissolves or disperses in the formulation to impart it's flavour thereto. In a further aspect of the invention the dosage means can be added to a dry or liquid form of medicament prior to reconstitution or dilution.
Preferably the tablet, powder or liquid flavouring material will be of a type which dissolves or disperses rapidly in contact with the liquid medicament, typically within a few seconds, or at most a few minutes, so that the flavour passes rapidly into the liquid material.
The quantity of flavouring substance may be such that when the flavouring substance passes into the pharmaceutical formulation which includes an active ingredient and/or excipients which have a strong, unpleasant or otherwise unacceptable taste, the taste is masked to such an extent that the taste of the liquid material becomes palatable. Preferably the quantity of flavouring substance should be sufficient such that addition of one or more of the dosage means imparts an acceptable flavour to a volume of made up liquid which is normally dispensed by the pharmacist sufficient for a course of treatment of a patient, for example ca 50-600 ml, or consumed as a unit dose by the patient. The quantity of flavouring substance may need to be increased, and/or more of the substrates used if the system is intended for use with a formulation in which the active constituents and/or excipients therein have a particularly strong taste.
The flavouring substance may be any edible flavouring substance which is acceptable and approved for use with foods and/or pharmaceutical formulations. Very many such substances are known. The flavouring substance may for example be a natural or artificial flavouring, such as of a fruit, vegetable or confectionery taste. If desired more than one flavouring can be used in a single dosage means. Additionally or alternatively the flavouring substance may comprise a sweeten
Buxton Philip Christopher
Duncan Janice
Johnson Wendy
Tovey Geoffrey David
Kanagy James M.
Kinzig Charles M.
Page Thurman K.
SmithKline Beecham p.l.c.
Tran S.
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