Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Patent
1997-01-15
1998-04-21
Schofer, Joseph L.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
424440, 424441, 424465, 424487, 424489, A61K 4700, A61K 968
Patent
active
057415072
DESCRIPTION:
BRIEF SUMMARY
The present invention deals with a ranitidine tablet containing at least 30% ranitidine hydrochloride and having a hydroxypropylmethylcellulose containing coating as well as a method for producing the desired coating when manufacturing such ranitidine tablets.
It is conventional to provide a coating on pharmaceutical tablets for oral administration, either by dragging or by means of a film-coating technique, i.e. a process similar to a spray-painting.
The present invention is related to the use of this last mentioned technique on tablets containing ranitidine hydrochloride.
Usually coating of tablets for oral administration is performed for various purposes. Among such purposes are: improvement of the visual appearance of the tablets, that means colour, lustre etc., avoidance of unpleasant odour and taste by encapsulating active components having such unpleasant properties, reduction of friction to mucusae in throat and pharynx to make the tablets easier to swallow. Coating is also made with a purpose of protecting the active components of the tablets against moisture and light, thereby increasing the shelf-life of the tablets by delaying a decrease of activity and possibly discolouration caused by moisture and light.
However, it is important that the shielding of the tablets against the surroundings performed by the tablet coating is not so efficient that the bioavailability of the administered drugs be decreased to any substantial extent due to prevention or delaying of the disintegration of the tablet in the intestine or due to prevention of delaying of dissolution of the active substance from the tablet out into the digesting liquids.
Ranitidine, having the IUPAC-name nitro-1,1-ethendiamine, is a H.sub.2 -receptorantagonist which is extensively used for treating gastric ulcer. It is used as the hydrochloride salt and is mainly administered as tablets for oral use.
The activity of ranitidine is at such a level that ranitidine tablets are suitably marketed having a contents of ranitidine hydrochloride from approximately 100 mg to a few hundred mgs. This means that it is desired that the amount of excipients and adjuvants in the tablets is kept relatively low to avoid that the tablets become too large and thereby unpleasant to swallow. For this reason it is preferred that the ranitidine hydrochloride constitutes at least 30% of the tablet.
Since ranitidine hydrochloride is hygroscopic and is degraded by moisture and light whereby a decrease in activity and especially a discolouration takes place, there is a special need for an effective coating of ranitidine hydrochloride tablets.
However, ranitidine hydrochloride has properties rendering it difficult to provide the tablets with a coating which is effectively protecting, but which does not decrease the bioavailability.
This is probably due to the fact that ranitidine hydrochloride due to the very high solubility thereof in water and in many organic liquids penetrates up through the applied coating during the drying thereof and also subsequently under the influence of humidity in the air. The amount of ranitidine hydrochloride, which penetrates through the coating or just migrates up into the coating, will be subjected to a rapid discolouration under influence of light and moisture.
An obvious possibility for reducing said problems connected to coating of ranitidine hydrochloride tablets would be to reduce the unfortunate action of the ranitidine hydrochloride by applying a larger amount of inert excipients in the tablet composition. However, due to the above mentioned desire of keeping the amount of ranitidine hydrochloride at at least 30%, this possibility is not commercially acceptable.
Thus, coating of ranitidine tablets involves special problems. It has been suggested (cf. published Danish patent application No. 2337/89) to solve some of the problems related to coating of ranitidine hydrochloride tablets by using a coating of hydroxypolymethylcellulose containing as plastifier triacetine. Triacetine is a plastifier which previously had found general a
REFERENCES:
patent: 4880636 (1989-11-01), Franz
patent: 5084278 (1992-01-01), Mehta
patent: 5635200 (1997-06-01), Douglas et al.
Gebhard-Hansen Knud Erik
Kann Helle
Pedersen S.o slashed.ren Bols
A/S Gea Farmaceutisk Fabrik
Schofer Joseph L.
Shelborne Kathryne E.
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