Process for manufacturing bite-dispersion tablets
AssigneeSmithKline Beecham Corporation
InventorsGopadi M. Venkatesh, Nageswara R. Palepu
Life of this patent
Estimating the term…
Abstract
This invention relates to a method for the manufacture of Bite-dispersion tablets which disperse easily and quickly in the oral cavity, after a gentle bite, without the aid of water, and if necessary includes masking the bitter taste of medicaments. The process comprises preparing a dry granulation of one or more of medicaments blended with suitable excipients, flavors and a combination of a waxy material and phospholipid (BMI-60) or an intense sweetener derived from fruit flavonoids (Neohesperidine) for taste-masking and compressing into tablets which can be packaged in bottles or blisters using conventional equipment.
Claims101
A process for the preparation of a fast dispersing tablet for oral administration, which process comprises:
- (i) admixing together intragranular components which are at least one pharmaceutically active ingredient, one or more pharmaceutically acceptable excipients which are xylitol, directly compressible mannitol, maltodextrin and sorbital, or a combination thereof;
- a waxy material which is a synthetic or natural wax, a mono-, di- or tri-(C10-30) aliphatic esters of glycerol, a (C10-30) straight chain aliphatic alcohol, a (C10-30) aliphatic acid, and a (C10-30) aliphatic ester, or combinations thereof;
- an intense sweetener or taste-masking agent;
- and optionally a disintegrant;
- and
- (ii) preparing the admixture of step (i) for compression by dry granulation, slugging, roller compacting, milling or sieving, or combinations thereof;
- and
- (iii) blending the product of step (ii) with an extragranular component which comprises a pharmaceutically acceptable excipient of xylitol, directly compressible mannitol, maltodextrin or sorbitol, or a combination thereof;
- and optionally a sweetener or taste-masking agent;
- (iv) compressing into tablets.
A process for the preparation of fast dispersing tablets for oral administration, which process comprises:
- (i) admixing together intragranular components include at least one microencapsulated pharmaceutically active ingredient, one or more pharmaceutically acceptable excipients, a waxy material which is a synthetic or naturally occurring wax, a mono-, di- or tri-(C10-30) aliphatic ester of glycerol, a (C10-30) straight chain aliphatic alcohol, a (C10-30) aliphatic acid, or a (C10-30) aliphatic ester, or combinations thereof;
- and optionally an intense sweetener or taste-masking agent;
- and a disintegrant;
- (ii) preparing the admixture of step (i) for compression by dry granulation, slugging, roller compacting, milling or sieving, or combinations thereof;
- and
- (iii) blending the product of step (ii) with an extragranular component comprising a pharmaceutically acceptable excipient selected from the group consisting of a xylitol, directly compressible mannitol, maltodextrin or sorbitol;
- and optionally a sweetener/taste-masking agent and a flavoring agent;
- and
- (iv) compressing into tablets.
A fast-dispersing pharmaceutical tablet formulation comprising compacted granulates;
- the intragranular granulates comprising a medicament together with a combination of a waxy material which is a synthetic or naturally occuring wax, a mono-, di- or tri-C10-30 aliphatic esters of glycerol, a (C10-30) straight chain aliphatic alcohol, a (C10-30) aliphatic acid, or a (C10-30) aliphatic ester, or combinations thereof and a taste-masking agent or an intense sweetner, optionally with a flavoring agent, and a pharmaceutically acceptable excipent selected from xylitol, mannitol, maltodextrin, or sorbitol, or a combination thereof, the granulates being compacted together into a tablet form together with extragranular components which are a disintegrant, a sweetner and/or taste-masking agent, and a pharmaceutically acceptable excipent selected from xylitol, mannitol, maltodextrin, or sorbitol, or a combination thereof.
A fast-dispersing pharmaceutically acceptable tablet for oral administration comprising:
- a) 1-60 parts of at least one medicament;
- and
- b) 10-90 parts of xylitol;
- and
- c) 0.5-20 parts of a waxy material, selected from glyceryl behenate or glycerol palmitostearate;
- and
- d) optionally, 0.5-7 parts of an intense sweetener and/or taste masking agent.
Dependencies are inferred from the claim text.