Flash-melt pharmaceutical oral dosage form, process for its preparation and process for producing granules suitable for its preparation

• Main Authors: KOTHARI SANJEEV H, DESAI DIVYAKANT
• Format: Patent
• Language: Czech; English
• Published: 30.04.2008
• Subjects: AGRICULTURE; ANIMAL HUSBANDRY; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES, AS HERBICIDES; FISHING; FORESTRY; HUMAN NECESSITIES; HUNTING; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTSTHEREOF; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS; TRAPPING

Rychle se rozpouštející farmaceutická dávková forma, která se rozpadá v ústech do 25 sekund, která zahrnuje lécivo a kombinaci excipientu, jež zahrnuje, vztaženo na celkovou hmotnost uvedené dávkové formy, od 4 do 8 % hmotn. superdezintegrantu; od 20 do 70 % hmotn. dispergacního cinidla, kterým je kremicitan vápenatý; od 1 do 10 % hmotn. distribucního cinidla vybraného ze souboru zahrnujícího amorfní oxid kremicitý, mikronizovaný oxid kremicitý,kremelinu, mastek, kaolin a trojkremicitan horecnatohlinitý; a od 10 do 50 % hmotn. pojiva. In the present invention, there is provided a flash-melt pharmaceutical dosage form disintegrating in a mouth within 25 seconds and comprising a medicament and a combination of excipients including, based on the total weight of the said dosage form, from about 4 to about 8 percent by weight of a superdisintegrant, from about 20 to about 70 percent by weight of a dispersing agent being represented by calcium silicate, from about 1 to about 10 percent by weight of a distributing agent being selected from the group consisting of amorphous silica, fumed silica, diatomaceous earth, talc, kaolin and magnesium aluminum trisilicate, and from about 10 to about 50 percent by weight of a binder.