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WO2005102290A1 - Compositions pharmaceutiques formees d'un biguanide et d'une sulfonyluree - Google Patents

Compositions pharmaceutiques formees d'un biguanide et d'une sulfonyluree Download PDF

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Publication number
WO2005102290A1
WO2005102290A1 PCT/IB2005/001081 IB2005001081W WO2005102290A1 WO 2005102290 A1 WO2005102290 A1 WO 2005102290A1 IB 2005001081 W IB2005001081 W IB 2005001081W WO 2005102290 A1 WO2005102290 A1 WO 2005102290A1
Authority
WO
WIPO (PCT)
Prior art keywords
dosage form
metformin
release
core
glimepiride
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2005/001081
Other languages
English (en)
Inventor
Amit Kumar Kesarwani
Manish Chawla
Rajeev Singh Raghuvanshi
Ashok Rampal
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ranbaxy Laboratories Ltd
Original Assignee
Ranbaxy Laboratories Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ranbaxy Laboratories Ltd filed Critical Ranbaxy Laboratories Ltd
Publication of WO2005102290A1 publication Critical patent/WO2005102290A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Definitions

  • the present invention relates to an oral solid dosage form that includes a combination of a biguanide and a sulfonylurea, wherein the dosage form provides an extended-release phase of the biguanide and an immediate-release coating containing the sulfonylurea. Also provided is a process for the preparation of the oral solid dosage form and method of its use.
  • Diabetes mellitus of type II is a progressive metabolic disorder with diverse pathologic manifestations and is often associated with lipid metabolism and glycometabolic disorders.
  • the long-term effects of diabetes result from its vascular complications: the micro vascular complications of retinopathy, neuropathy and nephropathy and the macrovascular complications of cardiovascular, cerebrovascular and peripheral vascular diseases.
  • vascular complications the micro vascular complications of retinopathy, neuropathy and nephropathy and the macrovascular complications of cardiovascular, cerebrovascular and peripheral vascular diseases.
  • diet regulation and exercise are the preliminary course of treatment for type II diabetes; however, these are generally followed by the administration of oral hypoglycemic agents.
  • the current drugs used for managing type II diabetes and its precursor syndromes, such as insulin resistance include biguanides and sulfonylureas, among others. Biguanides, which include metformin, phenformin and buformin, help control the blood glucose level by decreasing hepatic glucose production and reducing the intestinal absorption of glucose.
  • Sulfonylureas which include glipizide, glimepiride, glyburide, glibonuride, glisoxepide, gliclazide acetohexamide, chlorpropamide, tolazamide, and tolbutamide, among others, help in controlling or managing NIDDM by stimulating the release of insulin from the pancreas.
  • Biguanides and sulfonylureas are individually commercially available in the form of tablets as either oral immediate-release (IR) formulations or controlled-release (CR.) formulations. These are typically administered orally to patients in need thereof, in protocols calling for the single administration of the individual ingredient.
  • Biguanides particularly metformin, improve glucose tolerance but do not stimulate insulin secretion.
  • Sulfonylureas lower blood glucose levels acutely by stimulating the release of insulin from the pancreas, an effect that is dependent upon properly functioning beta cells in the pancreatic islets.
  • a combination therapy of a biguanide and sulfonylurea has a synergistic effect on glucose control, since both agents act by different, but complementary, mechanisms. This combination therapy plays an important therapeutic role, since it allows an effective metabolic control in NIDDM patients in whom the therapy with only sulfonylureas or only biguanides has become ineffective.
  • the biguanide which has a shorter half-life, needs to be administered in a controlled or extended-release form; whereas the sulfonylurea, particularly glimepiride, which has a longer half-life, needs to be administered in immediate-release form.
  • a large disparity between the doses of the two agents and differences in their solubility and permeability profiles pose difficulties in their formulation into a single dosage form.
  • WO 04/ 45622 discloses a dosage form which includes one layer or a core from which one high-dose, water-soluble active is released on a prolonged basis and a coating or layer from which low-dose, water-insoluble active is released on an immediate-release basis can be prepared in a manner that provides a high degree of uniformity.
  • FDC fixed dose combination
  • an oral solid dosage form which includes an extended-release core comprising a biguanide and an immediate-release coating comprising a sulfonylurea over the core.
  • the biguanide may be metformin, phenformin or buformin.
  • the sulfonylurea may include glipizide, glimepiride, glibonuride, glyburide, gliclazide, acetohexamide, chlorpropamide, tolazamide or tolbutamide.
  • an oral solid dosage form which includes an extended-release core comprising metformin and an immediate-release sulfonylurea containing coating applied to the core comprising glimepiride, one or more film-forming polymer (s), one or more solubilizers and one or more plasticizers; wherein the immediate- release coating is applied to the core using a non-aqueous solvent.
  • Embodiments of the pharmaceutical compositions may include one or more of the following features.
  • the metformin may be present at a concentration of from about 20 % to about 80% by weight of the dosage form and the glimepiride may be present at a concentration from about 0.05 % to about 10 % by weight of the dosage form.
  • the extended-release core may be prepared by dispersing metformin with one or more rate-controlling polymer to form a matrix or by layering onto pharmaceutically acceptable inert cores in an admixture with one or more rate-controlling polymers.
  • the one or more rate controlling polymers may include hydrophilic polymers, hydrophobic polymers, random- blcok copolymers, mixtures and blends thereof.
  • the extended-release core further may include one or more pharmaceutically acceptable excipients.
  • the one or more pharmaceutically acceptable excipients may include one or more of diluents, binders, lubricants, glidants, colorants and flavoring agents.
  • the extended-release core may be formulated as particles, pellets, beads, granules or tablets.
  • the core may be surrounded by a seal-coat.
  • the seal-coat may include one or more film-forming polymers.
  • the one or more film-forming polymers may be one or more of hydroxypropyl methylcellulose, ethyl cellulose, cellulose acetate, poly vinyl alcohol- maleic anhydride copolymers, acrylic polymers and copolymers and mixtures thereof.
  • the one or more film-forming polymers may also be one or more of polyvinyl pyrrolidone, vinyl acetate and N-vinylpyrrolidone copolymer, hydroxyl alkyl celluloses, methylcellulose, polyvinyl alcohol and mixtures thereof.
  • the one or more solubilizers may be one or more of polyethylene glycols, polyethoxylated fatty acids, medium chain glycerides, polyglycolyzed glycerides, diethylene glycol mono ethyl ether, cyclodextrin, polyoxyethylene, sorbitan fatty acid esters, sodium lauryl sulphate and mixtures thereof.
  • the one or more plasticizers may be one or more of citric acid alkyl esters, glycerol esters, sucrose esters, sorbitan esters, polyethylene glycols and mixtures thereof.
  • the non-aqueous solvents may be one or more of alcohols, ketones, chlorinated hydrocarbons and mixtures thereof.
  • the alcohols may be one or both of ethyl alcohol and isopropyl alcohol.
  • the ketones may be one or both of acetone and ethyl methyl ketone.
  • the chlorinated hydrocarbons may be dichloroethane, dichloromethane, trichloroethane and mixtures thereof.
  • an oral solid dosage form which includes a combination of metformin and glimepiride.
  • the dosage form when administered once daily under fed conditions, exhibits an area under the plasma concentration-time curve for metformin and glimepiride comparable to that exhibited by separate simultaneously administered, commercially available, extended-release tablet of metformin (GLUCOPHAGE XRTM) and an immediate-release tablet of glimepiride (AMARYLTM).
  • GLUCOPHAGE XRTM extended-release tablet of metformin
  • AMDTM immediate-release tablet of glimepiride
  • an oral solid dosage form which includes a combination of metformin and glimepiride.
  • an oral solid dosage form which includes an extended-release core comprising metformin and an immediate-release sulfonylurea coating comprising one or more film-forming polymer(s), one or more solubilizers and one or more plasticizers.
  • the immediate-release coating is applied to the core using a non-aqueous solvent.
  • the dosage form exhibits a T max of metformin which occurs at a time about 2.5 hours to about 12 hours administration to a human patient and exhibits a T max of glimepiride which occurs at a time about 1 hour to about 6 hours after administration to a human patient.
  • the pharmaceutical composition may include one or more of the following features.
  • the core may be surrounded by a seal-core.
  • Embodiments of the method may include one or more of the following features.
  • the dosage form may further include one or more of glitazones, insulin, alpha- glucosidase inhibitors, meglitinides, fibrates, statins, squalene synthesis inhibitors and angiotensin-converting enzyme inhibitors.
  • the method may further include concurrently or sequentially administering one or more of glitazones, insulin, alpha-glucosidase inhibitors, meglitinides, fibrates, statins, squalene synthesis inhibitors and angiotensin-converting enzyme inhibitors.
  • the inventors have developed an oral solid dosage form which includes a combination of biguanide and sulfonylurea.
  • the dosage form provides an extended-release core which includes a biguanide and an immediate-release coating which includes a sulfonylurea over the core.
  • suitable biguanides include one or more of metformin, phenformin, buformin and other pharmaceutically acceptable forms of the biguanide class.
  • metformin may be used.
  • the metformin include free base or a pharmaceutically acceptable salt thereof.
  • Suitable pharmaceutically acceptable salts of metformin include hydrochloride, fumarate, hydrobromide, succinate and embonate.
  • the daily effective dose of metformin may range from about 500 mg to about 2550 mg; particularly, the dose is a single dose of 250 mg to about 1000 mg.
  • the metformin in the present dosage form may be present at a concentration of about 20% to about 80% by weight of the dosage form.
  • Suitable sulfonylureas may include one or more of glipizide, glimepiride, glibonuride, glyburide, gliclazide, acetohexamide, chlorpropamide, tolazamide, and tolbutamide.
  • pharmaceutically acceptable forms of sulfonylureas including their salts, solvates, hydrates, polymorphs, complexes and other such products.
  • glimepiride may be used.
  • the daily effective dose of glimepiride may range from about 1 mg to about 8 mg once a day.
  • the glimepiride may be present from about 0.05% to about 10% by weight of the dosage form.
  • the area under the plasma concentration-time curve (AUC) for the test is said to be comparable to that of the reference when the test/reference (T/R) ratio of the geometric means based on log transformed data fall within 70% to about 143%) for area under the plasma concentration time curve.
  • the maximum plasma concentration (C ma ⁇ ) for the test is said to be comparable to that of the reference when the test/reference (T/R) ratio of the geometric means based on log- transformed data fall within 70 to about 143% for C max .
  • the biguanide may be incorporated into an extended-release core by dispersing in a rate-controlling polymer matrix, as described in WO 03/028704 and WO 03/039527.
  • the biguanide may be layered onto pharmaceutically acceptable inert cores or seeds in admixture with, or surrounded by, one or more rate-controlling polymers.
  • the matrix may be a uniform mixture of a biguanide, one or more rate-controlling polymers and one or more pharmaceutically acceptable excipient.
  • Suitable rate-controlling polymers may be hydrophilic, hydrophobic or mixtures thereof. These rate-controlling polymers may be present at a concentration of from about 5% to about 75% by weight of the dosage form.
  • Suitable hydrophilic rate-controlling polymers may include one or more of cellulose derivatives, such as hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose hydroxymethyl cellulose, carboxy methyl cellulose, methyl cellulose, sodium carboxymethyl cellulose and mixtures thereof; polyvinyl pyrrolidone, microcrystalline cellulose, polysaccharides, polyalkylene glycols, starch and starch derivatives; and mixtures thereof.
  • cellulose derivatives such as hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose hydroxymethyl cellulose, carboxy methyl cellulose, methyl cellulose, sodium carboxymethyl cellulose and mixtures thereof
  • polyvinyl pyrrolidone microcrystalline cellulose, polysaccharides, polyalkylene glycols, starch and starch derivatives; and mixtures thereof.
  • Suitable hydrophobic polymers may be include one or more of ethyl cellulose, cellulose acetate, cellulose acetate butyrate, hydroxypropyl methylcellulose phthalate, copolymers of acrylic or methacrylic acid esters, waxes, shellac, hydrogenated vegetable oil and mixtures thereof.
  • Suitable pharmaceutically acceptable excipients include one or more of diluents, binders, lubricants, glidants, colorants and flavoring agents.
  • Suitable diluents may include one or more of microcrystalline cellulose, lactose, dibasic calcium phosphate, mannitol, starch, sorbitol, sucrose, dextrose, maltodextrin and mixtures thereof.
  • Suitable binders may include one or more of polyvinyl pyrrolidone, hydroxyl propylcellulose, hydroxyl ethyl cellulose, hydroxyl propyl methylcellulose, gums, waxes, polyvinylalcohol and mixtures thereof.
  • Suitable lubricants may include one or more of silicon dioxide, colloidal silicon dioxide, talc, stearic acid, magnesium stearate, magnesium trisilicate, sodium benzoate, polyethylene glycol, sodium lauryl sulphate, fumaric acid, zinc stearate, paraffin, glyceryl behenate and mixtures thereof.
  • Suitable glidants may include one or more of talc, silicon dioxide, colloidal silicon dioxide, tribasic calcium phosphate, powdered cellulose and magnesium trisilicate.
  • the core may be formulated by any pharmaceutically acceptable technique including dry granulation, wet granulation, compaction, fluidized bed granulation and extrusion- spheronization.
  • the core may be compressed to form tablets or alternatively, formulated as plurality of discrete or aggregated particles, pellets, beads or granules. These pellets, beads, particles or granules may be filled into capsules.
  • the extended-release core may be coated to seal the core.
  • the coating layer may include any conventional coating formulation and may include one or more of film-forming polymers or binders.
  • Suitable film-forming polymers and binders include one or more of hydroxypropyl methylcellulose, ethyl cellulose, cellulose acetate, polyvinyl alcohol-maleic anhydride copolymers, acrylic polymers and copolymers; or mixtures thereof. These polymers may be applied using solvents including one or more of purified water organic solvents or mixture thereof, hi addition, the coating formulation may also include plasticizers.
  • the seal-coat around the core may be present at a concentration of from about 1% to about 5% and particularly from about 1.5% to about 3% by weight of the dosage form.
  • the immediate-release coating comprising sulfonylurea is applied directly onto the core or over the seal-eoated core.
  • the immediate-release coating includes one or more film- forming polymer(s), one or more solubilizers, one or more plasticizers and one or more additional pharmaceutically acceptable excipients including fillers, antiadherents, opacifiers and colorants.
  • Suitable film-forming polymer(s) may include one or more of hydroxypropyl methylcellulose, polyvinyl pyrrolidone, vinyl acetate and N-vinylpyrrolidone copolymer, hydroxyalkyl celluloses, methylcelluloses, polyvinyl alcohol and mixtures thereof.
  • Suitable solubilizers may include one or more of polyethylene glycols, polyethoxylated fatty acids, medium chain glycerides, polyglycolyzed glycerides, diethylene glycol mono ethyl ether, cyclodextrin, polyoxyethylene, sorbitan fatty acid esters, sodium lauryl sulphate and mixtures thereof.
  • Suitable plasticizers may include one or more of citric acid alkyl esters, glycerol esters, sucrose esters, sorbitan esters, polyethylene glycols, and mixtures thereof.
  • the immediate-release coating of sulfonylurea may be applied as a solution of the sulfonylurea in non-aqueous solvent due to the poor solubility of the sulfonylurea in an aqueous medium.
  • Layering with a non-aqueous sulfonylurea-solution is preferred over aqueous or non- aqueous suspension since on drying the suspension may form irregular deposits from which the low dose active is released non-uniformly.
  • the suspension requires the presence of additional excipients, such as suspending agents that are not required with preparing a solution.
  • solutions are easier to handle as compared to suspensions and the particle size of the active before going into solution holds less relevance.
  • Suitable non-aqueous solvents include one or more of alcohols, such as ethyl alcohol or isopropyl alcohol; ketones, such as acetone or ethyl methyl ketone; chlorinated hydrocarbons, such as dichloroethane, dichloromethane or trichloroethane; and mixtures thereof.
  • the immediate-release coating may be applied by any conventional technique including pan coating, spray coating, centrifugal fluidized coating and fluidized bed coating. Alternatively, the immediate-release coating may be applied by press-coating, dry compression or deposition over the extended-release core or seal-coated extended-release core. An outer protective coating layer comprising conventional coating formulations may be applied additionally over the immediate-release coating.
  • the coated cores may be dried under conditions effective for drying, such as in an oven or by means of fluidized bed dryer.
  • a method of treating non-insulin dependent diabetes niellitus in a patient in need thereof includes administering an oral solid dosage form comprising: (a) an extended-release core comprising metformin and (b) an immediate-release coating comprising glimepiride over the core.
  • the dosage form may further include one or more of glitazones, insulin, alpha- glucosidase inhibitors, meglitinides, fibrates, statins, squalene synthesis inhibitors and angiotensin-converting enzyme inhibitors.
  • glitazones insulin, alpha-glucosidase inhibitors, meglitinides, fibrates, statins, squalene synthesis inhibitors and angiotensin-converting enzyme inhibitors may be concurrently or sequentially administered.
  • the following non-limiting examples illustrate the process for making the oral dosage form disclosed in various embodiments of the specification.
  • Metformin hydrochloride was mixed with microcrystalline cellulose and purified water was added to the blend. 2.
  • Sodium carboxymethyl cellulose, hydroxypropyl methylcellulose and a part of magnesium stearate were mixed with blend of step 1.
  • Granules were prepared by roller compaction of the blend of step 2.
  • a seal-coat solution was prepared by dissolving hydroxypropylmethyl cellulose and polyethylene glycol in water, which was subsequently used to coat the core tablets of Step-4.
  • glimepiride was dispersed in methylene chloride followed by the addition of isopropyl alcohol to obtain a clear solution.
  • caprylocaproyl monoglyceride polyethylene glycol, sodium lauryl sulphate hydroxypropyl methylcellulose and copovidone were added under constant stining till a clear solution was obtained.
  • Tables 1 and 2 provide the in-vitro release profiles of metformin and glimepiride respectively from the tablets prepared by the composition and process of Example 4 in phosphate buffers pH 6.8 and 7.8, respectively (900 mL), USP 2 at 75 rpm.
  • Table 1 Release profile of metformin from tablets prepared as per Example 4 in simulated intestinal fluid (Phosphate buffer pH 6.8), 900 mL, USP 2 at 75 rpm.
  • Table 2 Release profile of glimepiride from tablets prepared as per Example 4 in Phosphate buffer pH 7.8, 900 mL, USP 2 at 75 rpm.
  • Test T Metformin ER + Glimepiride IR tablets (Example 4).

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Emergency Medicine (AREA)
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  • Hematology (AREA)
  • Obesity (AREA)
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  • General Chemical & Material Sciences (AREA)
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Abstract

La présente invention concerne une forme posologique solide orale qui comprend une combinaison d'un biguanide et d'une sulfonylurée, ladite forme posologique présentant une phase à libération prolongée du biguanide et un revêtement à libération immédiate contenant la sulfonylurée. Cette invention se rapporte également à un procédé de préparation de la forme posologique solide orale et à sa méthode d'utilisation.
PCT/IB2005/001081 2004-04-22 2005-04-21 Compositions pharmaceutiques formees d'un biguanide et d'une sulfonyluree Ceased WO2005102290A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN763/DEL/2004 2004-04-22
IN763DE2004 2004-04-22

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WO2005102290A1 true WO2005102290A1 (fr) 2005-11-03

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007072992A3 (fr) * 2005-12-22 2007-12-06 Takeda Pharmaceutical Preparation solide
US11672781B2 (en) 2018-05-07 2023-06-13 Prana Biosciences Inc Metaxalone formulations

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003026637A2 (fr) * 2001-09-28 2003-04-03 Sun Pharmaceutical Industries Limited Forme posologique pour traiter le diabete sucre
US20030147952A1 (en) * 2002-02-01 2003-08-07 Depomed, Inc. Manufacture of oral dosage forms delivering both immediate-release and sustained-release drugs
US20030187074A1 (en) * 2002-03-04 2003-10-02 Javed Hussain Oral compositions for treatment of diabetes
WO2004045622A1 (fr) * 2002-11-15 2004-06-03 Ranbaxy Laboratories Limited Formes galeniques pharmaceutiques de combinaisons de biguanide-sulfonyluree

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003026637A2 (fr) * 2001-09-28 2003-04-03 Sun Pharmaceutical Industries Limited Forme posologique pour traiter le diabete sucre
US20030147952A1 (en) * 2002-02-01 2003-08-07 Depomed, Inc. Manufacture of oral dosage forms delivering both immediate-release and sustained-release drugs
US20030187074A1 (en) * 2002-03-04 2003-10-02 Javed Hussain Oral compositions for treatment of diabetes
WO2004045622A1 (fr) * 2002-11-15 2004-06-03 Ranbaxy Laboratories Limited Formes galeniques pharmaceutiques de combinaisons de biguanide-sulfonyluree

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007072992A3 (fr) * 2005-12-22 2007-12-06 Takeda Pharmaceutical Preparation solide
US8071130B2 (en) 2005-12-22 2011-12-06 Takeda Pharmaceutical Company Limited Solid preparation
AU2006328328B2 (en) * 2005-12-22 2012-08-30 Takeda Pharmaceutical Company Limited Solid preparation containing an insulin sensitizer
CN101384251B (zh) * 2005-12-22 2014-09-03 武田药品工业株式会社 含胰岛素敏化剂的固体制剂
US11672781B2 (en) 2018-05-07 2023-06-13 Prana Biosciences Inc Metaxalone formulations

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