Bupropion hydrochloride is a water-soluble, crystalline solid, which is highly hygroscopic and susceptible to decomposition. From the above tabular data, it is clearly evident that there is no significant difference between dissolution profile of coated tablets of the invention Ex. Preferably, the lubricant is present in an amount of from 0.
Further methods involve the use of large particle size bupropion particles and exclusion of wet granulation techniques during manufacturing. The energy of activation for decomposition in aqueous solution pH Method of stabilizing bupropion hydrochloride tablets WO A2.
Mannitol serves dual purposes, firstly as weight-adjusting agents and secondly as a channel-forming agent in the tablet core. Bupropion described in US Patent Nos. In the disclosed methods and formulations, tablets are formed that combine bupropion hydrochloride, binders, fillers, glidants and lubricants and processing under low shear conditions that result in hard, chip-resistant tablets that exhibit improved cohesiveness and are easily and reproducibly formed without adhering to the compression punches.
It is found according to the present invention that if the said critical particle size of bupropion is used, it is not necessary to add acid stabilizer to stabilize the sustained release pharmaceutical composition.
The compactor can have rollers and powder transport screws of different designs. In accordance with yet another aspect of the present invention, there is provided a stable sustained release pharmaceutical composition of bupropion hydrochloride for oral administration wherein the composition is manufactured in the controlled processing conditions.
The film coating does not substantially affect the release rate of the bupropion hydrochloride from the composition, since the coating is instant dissolving type, which rapidly dissolves in the stomach. Examples of suitable lubricants include, for example, magnesium stearate, calcium stearate, stearic acid, glyceryl behenate, and polyethylene glycol, or any combination thereof and the like.
A2 Designated state s: Summary of the Invention. D finally, packing final product in specialized packs.
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. According to the invention, the film coating acts as a moisture barrier. Suitable weight adjusting agents include, for example, dicalcium phosphate dihydrate, calcium sulfate, lactose, cellulose, kaolin, mannitol, sodium chloride, dry starch, hydrolyzed starches, microcrystalline cellulose, powdered sugar, hydrogenated oils or any combination thereof and the like.
Pharmacokinetic parameters for both reference and test formulation have been shown in table:.
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The following examples are provided to enable one of ordinary skill in the art to prepare dosage forms of the invention and should not be construed as limiting the scope of the invention.
The tablets of the present invention comprising small particle size bupropion hydrochloride, have unexpected enhanced stability compared to the prior art bupropion hydrochloride tablets. For example, the method is simple and produces tablets having good stability during storage and desired sustained release characteristics. The present invention relates to a stable bupropion hydrochloride tablet and a method of stabilizing bupropion hydrochloride tablets, which also serves as an improved tabletting process for the preparation of sustained release bupropion hydrochloride tablets.
Binder can be added to the formulation in different ways: Requiring a process to use excipients of a specific particle size and density range, however, adds to costs and makes the process less robust. The present invention provides such compositions, and offers efficient and cost effective methods of preparation.