摘要:
The present document discloses compositions and procedures for applying pharmaceutical tablet coatings, recognized as film coatings wherein it is possible to obtain a final product coated with brightness superior to that achievable with typical compositions. The main difference in the composition is in the inclusion of the product derived from isomaltulose, which is a mixture of 6-O-α-D-glucopyranosyl-D-mannitol dihydrate with 6-O-α-D-glucopyranosyl-D- sorbitol, known as Isomalt, combined with a variety of film-forming polymers such as ethylene glycol and polyvinyl alcohol copolymer, copovidone, polyvinyl alcohol, and cellulosic derivatives, wherein the process conditions are advantageous as it is possible to handle high concentrations of solids in their preparation and wider applying temperature ranges than normally recommended for film coatings.
摘要:
The present invention provides a pharmaceutical composition, presented as a solid unit dosage form adapted for oral administration of sodium oxybate. The preferred unit dosage form is a tablet comprising a relatively high weight-percentage of sodium oxybate, in combination with a relatively small weight-percentage of total excipients. This permits the tablets to contain/deliver a pharmaceutically effective amount, e.g., about 0.5-1.5 g of sodium oxybate in each tablet with a delivery profile similar to that of the liquid form. The tablets are bioequivalent to the liquid form.
摘要:
Provided is an amorphous solid dispersion including a taxane or a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable polymer, and a pharmaceutically acceptable surfactant, which has enhanced solubility. Also provided is a method for preparing the solid dispersion. The present subject matter also provides a tablet having good solubility, bioavailability and stability, which comprises the amorphous solid dispersion, an intragranular excipient, and an extragranular excipient.
摘要:
A pharmaceutical composition containing, as the active ingredient, 4-{[(1R,2s,3S,5s,7s)-5-hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide, of which the solubility in an acidic pH region is different from that in a neutral pH region, with rapid disintegration property and rapid drug dissolution property as well as the expectation of a good drug dosing compliance, is provided. The pharmaceutical composition for oral administration of the present invention contains 4-{[(1R,2s,3S,5s,7s)-5-hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide or a pharmaceutically acceptable salt thereof, and a hydrophilic lubricant, and is useful as a pharmaceutical composition for oral administration with rapid disintegration property and rapid drug dissolution property as well as the expectation of a good drug dosing compliance.
摘要:
It is an object to provide a coating composition, which is used for an orally-administered preparation, the administering property of which has been improved, and/or an easily administrable preparation that does not affect dissolution property. The aforementioned object can be achieved using a coating composition comprising a first thickener selected from the group consisting of a carboxyvinyl polymer and sodium alginate, a polyvalent metal compound, and at least one type of a second thickener selected from the group consisting of xanthan gum, guar gum and sodium alginate, with the proviso that when the first thickener is sodium alginate the second thickener is not sodium alginate, or using a coating composition comprising, as thickeners, hydroxypropylmethylcellulose and sugar or sugar alcohol having a solubility at 20°C of 30 or more.