After about 30 seconds crystallization commenced, and the mixture was stirred for a further 30 minutes at ambient temperature to permit complete crystallization. Polysorbate was added to this solution.
The oral pharmaceutical dosage forms of the present invention are prepared by wet granulating paroxetine hydrochloride in the presence of a binder grade of a binder selected from the group consisting of povidone and copovidone, and a filler that is HCl free or non-hygroscopic, to obtain an intra-granular portion of a granulate, preparing a final blend from the granulate and converting the final blend to an oral pharmaceutical dosage form.
Form III paroxetine hydrochloride anhydrous having a bulk density exceeding about 0. The pure paroxetine free base thus obtained can then be used for the preparation of crystalline paroxetine hydrochloride hemihydrate as set out above. Methanol 15 ml was added to the solution and the mixture was refluxed for a further 2 hours.
Physics and chemistrh of the organic solid state Inter. Excipients that may function as glidants include for example colloidal silicon dixoide, magnesium trisilicate, powdered cellulose, starch, talc and tribasic calcium phosphate.
Summary for Tradename: PAXIL
Crystallization was not induced, but after stirring for 40 minutes at room temperature the contents of the flask suddenly set to a thick paste. Povidone Grade K 29—32 is a universal binder. The toluene solvate gave a distinctive IR spectrum, showing a characteristic band at cm Expired Patents for Tradename: The hot solution was treated with charcoal 2 g and alumina 1.
It should be appreciated that the pyridine solvate is believed to be more soluble in water than for example the propanol solvate. The mixture was allowed to stand overnight, then filtered. Paroxetine hydrochloride tablets are particularly susceptible to becoming soft during storage, especially under accelerated aging conditions.
Subsequent repetition of this process has resulted in a propanol solvate of paroxetine hydrochloride. The clear pale yellow solution was seeded with paroxetine hydrochloride anhydrate Form A, ultrasonicated and stirred at room temperature for several hours. The warm solution was seeded with paroxetine hydrochloride anhydrate Form B and ultrasonicated, whereupon the pale red solution rapidly crystallized. Stable pharmaceutical formulation of paroxetine hydrochloride anhydrous and a process for preparation thereof.
Active agent delivery sytems and methods for protecting and administering active agents.
Thus the use of the common ion effect when using diluted hydrochloric acid may help prevent dissolution of the solvate and subsequent conversion to the hydrochloride hemi-hydrate. A pharmaceutical composition according to claim 2wherein granules in the region of the center of the active core are surrounded with and contacted by the moisture barrier coating.
A pharmaceutical preparation as claimed in claim 9wherein dibasic calcium phosphate or microcrystalline cellulose is used as a diluent. The flask was sealed and allowed to cool, whereupon the pale red solution spontaneously crystallized. Patent Expiration Apotex Technologies. IMS after adding aqueous hydrochloric acid to a solution of the free base or by crystallising or recrystallising paroxetine hydrochloride from a solvent system containing water e.
More specifically, the invention relates to a novel process of preparing a stabilized oral dosage form of an active pharmaceutical ingredient API such as paroxetine hydrochloride and a novel process for improving the stability of the said active pharmaceutical ingredient API prior to incorporating into an oral delivery system.
The solvent-wet cake was dried in high vacuum over phosphorus pentoxide.