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(2) Patent Application Publication (10) Pub. No.: US 2006/0024365A1 Vaya Et Al

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(2) Patent Application Publication (10) Pub. No.: US 2006/0024365A1 Vaya Et Al US 20060024.365A1 (19) United States (2) Patent Application Publication (10) Pub. No.: US 2006/0024365A1 Vaya et al. (43) Pub. Date: Feb. 2, 2006 (54) NOVEL DOSAGE FORM (30) Foreign Application Priority Data (76) Inventors: Navin Vaya, Gujarat (IN), Rajesh Aug. 5, 2002 (IN)................................. 699/MUM/2002 Singh Karan, Gujarat (IN); Sunil Aug. 5, 2002 (IN)...... ... 697/MUM/2002 Sadanand, Gujarat (IN); Vinod Kumar Jan. 22, 2003 (IN)................................... 80/MUM/2003 Gupta, Gujarat (IN) Jan. 22, 2003 (IN)................................... 82/MUM/2003 Correspondence Address: Publication Classification HEDMAN & COSTIGAN P.C. (51) Int. Cl. 1185 AVENUE OF THE AMERICAS A6LK 9/22 (2006.01) NEW YORK, NY 10036 (US) (52) U.S. Cl. … 424/468 (22) Filed: May 19, 2005 A dosage form comprising of a high dose, high solubility active ingredient as modified release and a low dose active ingredient as immediate release where the weight ratio of Related U.S. Application Data immediate release active ingredient and modified release active ingredient is from 1:10 to 1:15000 and the weight of (63) Continuation-in-part of application No. 10/630,446, modified release active ingredient per unit is from 500 mg to filed on Jul. 29, 2003. 1500 mg; a process for preparing the dosage form. Patent Application Publication Feb. 2, 2006 Sheet 1 of 10 US 2006/0024365 A1 FIGURE 1 FIGURE 2 FIGURE 3. Patent Application Publication Feb. 2, 2006 Sheet 2 of 10 US 2006/0024365 A1 FIGURE 4 (a) 7 FIGURE 4 (b) Patent Application Publication Feb. 2, 2006 Sheet 3 of 10 US 2006/0024365 A1 FIGURE 5 120 1 00 - 80 • 60 40 20 C 2 4 6. 8 10 12 1 4 1 6 18 20 22 24 26 Time (hour . - Patent Application Publication Feb. 2, 2006 Sheet 4 of 10 US 2006/0024365 A1 FIGURE 6 120 + : 100 0 2 4 6. 8 1 O 12 14 16 18 20 22 24 26 Time (hour) Patent Application Publication Feb. 2, 2006 Sheet 5 of 10 US 2006/0024.365 A1 FIGURE 7 60 40 O 2 4 6 8 10 12 1 4 16. 1 & 20 22 24 26 Time (hour) Patent Application Publication Feb. 2, 2006 Sheet 6 of 10 US 2006/0024365 A1 FIGURE 8 :; 12. Time [ Hours ) Patent Application Publication Feb. 2, 2006 Sheet 7 of 10 US 2006/0024.365 A1 FIGURE 9 12 Time [ Hours ) Patent Application Publication Feb. 2, 2006 Sheet 8 of 10 US 2006/0024365 A1 FIGURE 10 O 2 4 6 8 10 12 14 16 18 2C 22 24 Time [Hours] Patent Application Publication Feb. 2, 2006 Sheet 9 of 10 US 2006/0024365 A1 FIGURE I J ; 2 4 O O O 2 4 6 8 I O 12 14 T 6 18 20 22 2 Time [ Hours ) - Patent Application Publication Feb. 2, 2006 Sheet 10 of 10 US 2006/0024365 A1 FIGURE 12 200 180 160 ; 140 120 . 100 - 8 O O 4 8 12 16 20 24 Time Hours] US 2006/0024.365 A1 Feb. 2, 2006 NOVEL DOSAGE FORM [0010] Block Jurgen et. al. describes in PCT application No. WO 01/72286 A1 a formulation of vitamin composition [0001] This application is a continuation-in-part of Ser. whereas a beadlet comprises a slow release core coated by No. 10/630,446, filed Jul. 29, 2003. a controlled release coating. The sustained release core is FIELD OF INVENTION coated with an immediate release layer. [0002] This invention relates to a dosage form comprising [0011] Richard Ting and Charles Hscao describes in U.S. of a high dose, high solubility active ingredient as modified Pat. No. 6,372,254 B1 a press coated, pulsatile active release and a low dose active ingredient as immediate ingredient delivery system which comprises a core of imme release where the weight ratio of immediate release active diate release, enveloped by an extended release compart ingredient and modified release active ingredient is from 1:1 ment. to 1:15000 and the weight of modified release high dose high solubility active ingredient per unit is from 500 mg to 1500 [0012] The need to use active ingredients with different mg and the weight of immediate release active ingredient is and complementary mechanisms of action frequently arises up to 500 mg; a process for preparing the formulation. Low in treatment of diabetes. There are several reasons to do this, dose active ingredient in present invention can optionally be namely, the disease itself is progressive, with deterioration also in a form of modified release. of glycemic control over time; mono-therapeutic attempts to achieve and maintain glycemic control often fail in the long BACKGROUND OF THE INVENTION run; multiple defects in the disease and consequently pri [0003] Combining two active ingredients in one pharma mary drug failures (1,2,3). ceutical unit to improve patient compliance is known in [0013] Current guidelines for combination therapy advise literature. It can be either in the form of two or more active the use of agents with differing and complementary mecha ingredients in immediate release form or a combination of nisms of action in order to maximize therapeutic activity and immediate release and modified release form. There are reduce toxicity. Earlier introduction of combination therapy various techniques by which the combination of immediate is increasingly being recommended. The commonly com release and modified release is formulated in single dosage bined active ingredients include biguanides (metformin)+ form. sulphonylureas, biguanides#PPAR2 agonists(thiazolidinedi [0004] Several examples of formulations having combi ones), sulphonylureas--thiazolidinediones, non-sulfonylurea nation of immediate release active ingredient and modified secretagogues (repaglinide)+biguanides etc. Fixed dose release active ingredient are described below. combinations of many of the above mentioned co-administer active ingredients have also been approved by the FDA. [0005] Shoichi Higo and Kazuo Igusa describes in U.S. Most of these combinations are conventional formulations Pat. No. 5,985,843 various types of pharmaceutical formu combined together into a single tablet. However, because of lations, which consists of a delayed release of sucralfate and the disparity in the duration of action (half-life), these an immediate release fraction of another active ingredient. combinations are given twice or thrice a day. The pharmaceutical dosage forms are a tablet formulation containing immediate release and delayed release granules; [0014] To reduce this disparity in the duration of action, a a two or three layer tablet; a tablet with delayed release core novel strategy would be to combine a sustained release surrounded by immediate release shell; a delayed release formulation of one active ingredient (shorter duration of tablet/granule coated with a film of immediate release active action) with conventional formulation (long duration of ingredient. action) of another active ingredient. This would make it possible to give the active ingredients in same dosing [0006] Similarly Jurgen Zeidler et. al describes in U.S. frequency. Pat. No. 6,001,391 a process for producing solid combina tion tablets, which have at least two phases. The one of the [0015] This type of combination will give better compli two phases is processed by melt extrusion technique and ance and a relative freedom from mealtime drug adminis contains a water soluble or swellable binder. tration, thus, improving the quality of life. More importantly, because of prolonged duration of action, it shall produce a [0007] A compressed V-shaped center scored double layer stricter control of blood glucose and consequently less tablet is disclosed by George M. Krause et al in U.S. Pat. diabetic complications. No. 3,336,200, one layer of which contains immediate release Active Ingredient and the other layer contains sus [0016] The techniques described above do not work well tained release Active Ingredient. The tablet is divisible in when the difference in the dose of active ingredients are high two equal halves. for example where the weight ratio of active ingredients is from 1:1 to 1: 15000 and the dose of modified release active [0008] Similarly Jacob A. Glassman described in U.S. Pat. ingredient per unit is from 500 mg to 1500 mg. The No. 4,503,031 a super fast starting, slow release medicinal techniques described in the prior art do not give good results tablet, wherein the tablet is comprised of two layers of when the active ingredient is highly soluble. The weight of compressed matrix that are fused together by means of the dosage form becomes very high, or complicated process readily dissolvable adhesive substance. for manufacturing is required, or accurate dosing of low [0009] Allan A. Rubin describes in U.S. Pat. No. 6,238, dose active ingredient is difficult when the techniques 699 B1 a pharmaceutical dosage form of carbidopa and reported in the prior art are utilized to make formulation with levodopa where both the Active Ingredients are present as high dose, high solubility active ingredient in the form of immediate release and sustained release. The formulation is modified release and low dose active ingredient into imme in the form of inlay tablet or bilayered tablet or a capsule diate release or modified release form where the weight ratio containing pellets. of low dose active ingredient and high dose, high solubility US 2006/0024.365 A1 Feb. 2, 2006 active ingredient is from 1:1 to 1:15000 and the weight of weight of modified release active ingredient per unit is from modified release active ingredient per unit is from 500 mg to 500 mg to 1500 mg. Low dose active ingredient in present 1500 mg and also it is inconvenient to swallow due to large invention can optionally be also in a form of modified size.
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