A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/54 (2006.01) A61K 9/14 (2006.01)
Patent
CA 2718257
The present invention is directed to pharmaceutical compositions, and methods of making such compositions, wherein the compositions comprise a plurality of TPR and RR particles, wherein: the TPR particles each comprise a core coated with a TPR layer; the core comprises a weakly basic, poorly soluble drug and a pharmaceutically acceptable organic acid separated from each other by an SR layer; the RR particles each comprise the weakly basic, poorly soluble drug, and release at least about 80 wt.% of the weakly basic, poorly soluble drug in about 5 minutes when dissolution tested using United States Pharmacopoeia (USP) dissolution methodology (Apparatus 2 - paddles@ 50 RPM and a two-stage dissolution medium at 37°C (first 2 hours in 0.1N HCl followed by testing in a buffer at pH 6.8).
La présente invention concerne des compositions pharmaceutiques, et des procédés de fabrication de ces compositions. Les compositions comprennent une pluralité de particules TPR et RR. Les particules TPR comprennent chacune un noyau enrobé dune couche TPR. Le noyau comprend un médicament peu soluble et faiblement basique et un acide organique de qualité pharmaceutique séparés lun de lautre par une couche SR. Les particules RR comprennent chacune le médicament peu soluble et faiblement basique et libèrent au moins 80 % en poids environ du médicament peu soluble faiblement basique en 5 minutes environ selon le test de dissolution au moyen de la méthode de dissolution de la pharmacopée des Etats-Unis (USP) (Appareil 2 palette tournante à 50 rpm et milieu de dissolution à deux étapes à 37°C (2 premières heures dans du 0,1N HC1 suivies par un test dans un tampon à un pH de 6,8).
Lai Jin-Wang
Purohit Vivek
Venkatesh Gopi
Vyas Nehal H.
Aptalis Pharmatech Inc.
Deeth Williams Wall Llp
Eurand Inc
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