Some content of this application is unavailable at the moment.
If this situation persist, please contact us atFeedback&Contact
1. (WO1997017947) DIRECTLY COMPRESSIBLE HIGH LOAD ACETAMINOPHEN FORMULATIONS
Latest bibliographic data on file with the International Bureau

Pub. No.: WO/1997/017947 International Application No.: PCT/US1996/018903
Publication Date: 22.05.1997 International Filing Date: 12.11.1996
IPC:
A61K 9/20 (2006.01) ,A61K 31/167 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
20
Pills, lozenges or tablets
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
16
Amides, e.g. hydroxamic acids
165
having aromatic rings, e.g. colchicine, atenolol, progabide
167
having the nitrogen atom of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
Applicants:
EDWARD MENDELL CO., INC. [US/US]; 2981 Route 22 Patterson, NY 12563, US
Inventors:
HUNTER, Edward, A.; US
SHERWOOD, Bob, E.; US
ZELEZNLK, Joseph, A.; US
Agent:
RASKIN, Martin, G. ; Steinberg, Raskin & Davidson, P.C. 1140 Avenue of the Americas New York, NY 10036, US
Priority Data:
08/558,33515.11.1995US
Title (EN) DIRECTLY COMPRESSIBLE HIGH LOAD ACETAMINOPHEN FORMULATIONS
(FR) FORMULATIONS D'ACETAMINOPHENE A CHARGE ELEVEE DIRECTEMENT COMPRESSIBLES
Abstract:
(EN) Direct compressed solid pharmaceutical dosage forms containing: a) from about 40 to about 95 % by weight acetaminophen; b) from about 1 to about 60 % by weight of a direct compression vehicle comprising microcrystalline cellulose; and c) from about 0.01 to about 4.0 % by weight of a pharmaceutically-acceptable lubricant are disclosed. The acetaminophen and direct compression vehicle are combined under high shear conditions which are sufficient to transform acetaminophen and direct compression vehicle into a homogenous granulate without degradation. In preferred aspects of the invention, the lubricant is also combined with the acetaminophen and direct compression vehicle under high shear conditions. Methods of preparing the directly compressed solid pharmaceutical dosage forms and methods of treatment with the dosage forms are also disclosed. The methods are particularly well suited for preparing directly compressed dosage forms containing high load (i.e., up to 80 % or greater) amounts of acetaminophen based on the weight of the total tablet.
(FR) L'invention concerne des formes galéniques pharmaceutiques solides directement comprimées contenant: a) d'environ 40 à environ 95 % en poids d'acétaminophène; b) d'environ 1 à environ 60 % en poids d'un véhicule de compression directe comprenant de la cellulose microcristalline; et c) d'environ 0,01 à environ 4,0 % en poids d'un lubrifiant pharmaceutiquement acceptable. L'acétaminophène et le véhicule de compression directe sont combinés dans des conditions de cisaillement élevé qui sont suffisantes pour transformer l'acétaminophène et le véhicule de compression directe en un granulat homogène sans altération. Dans des aspects préférés de l'invention, le lubrifiant est également combiné avec l'acétaminophène et le véhicule de compression directe dans des conditions de cisaillement élevé. L'invention concerne également des procédés de préparation de ces formes galéniques pharmaceutiques solides directement comprimées et des méthodes de traitement avec ces formes galéniques. Les procédés conviennent particulièrement bien pour préparer des formes galéniques directement comprimées contenant des quantités à charge élevée (c'est-à-dire, atteignant 80 % ou davantage) d'acétaminophène sur la base du poids du comprimé entier.
Designated States: AL, AM, AT, AU, AZ, BB, BG, BR, BY, CA, CH, CN, CZ, DE, DK, EE, ES, FI, GB, GE, HU, IS, JP, KE, KG, KP, KR, KZ, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, TJ, TM, TR, TT, UA, UG, UZ, VN
African Regional Intellectual Property Organization (ARIPO) (KE, LS, MW, SD, SZ, UG)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (AT, BE, CH, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)
Also published as:
NO19973123MXPA/a/1997/005281EP0805675JPH10506412 CN1168094CA2208322
EA199700110KR1002363260000*AU1997011239