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WO2006046114A2 - Formes posologiques osmotiques a taux croissant de liberation du medicament, et leurs procedes de preparation - Google Patents

Formes posologiques osmotiques a taux croissant de liberation du medicament, et leurs procedes de preparation Download PDF

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Publication number
WO2006046114A2
WO2006046114A2 PCT/IB2005/003183 IB2005003183W WO2006046114A2 WO 2006046114 A2 WO2006046114 A2 WO 2006046114A2 IB 2005003183 W IB2005003183 W IB 2005003183W WO 2006046114 A2 WO2006046114 A2 WO 2006046114A2
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WO
WIPO (PCT)
Prior art keywords
drug
dosage form
cellulose acetate
osmotic dosage
layer
Prior art date
Application number
PCT/IB2005/003183
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English (en)
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WO2006046114A3 (fr
Inventor
Rajan Kumar Verma
Narayanan Badri Viswanathan
Rajeev Singh Raghuvanshi
Ashok Rampal
Original Assignee
Ranbaxy Laboratories Limited
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Publication date
Application filed by Ranbaxy Laboratories Limited filed Critical Ranbaxy Laboratories Limited
Publication of WO2006046114A2 publication Critical patent/WO2006046114A2/fr
Publication of WO2006046114A3 publication Critical patent/WO2006046114A3/fr

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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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Definitions

  • the technical field of the present invention relates to osmotic dosage forms that provide drug release at an ascending release rate, and processes for preparation thereof.
  • Osmotic drug delivery systems show better in vitro-in vivo correlation as their performance of osmotic drug delivery systems is reported to be independent of pH and contents of the gastrointestinal tract. Moreover, they are subject to various mechanical stresses encountered within the gut. Hence, properly designed osmotic systems may prove to be of paramount importance.
  • Osmotic dosage forms introduced by F. Theewas in J. Pharm. ScL, Vol. 64, 12,
  • the coated tablet includes a homogenous core tablet of drug coated with a semi-permeable wall/layer and an aperture created through the wall for the release of the contents from the core.
  • Theewas's osmotic dosage forms have been improved by replacing the homogenous core with a multicompartment core comprising a separate drug layer and push layer, commonly known as "push-pull" osmotic systems.
  • U.S. Patent No. 4,111,202 assigned to Alza Corp. describes the fabrication of a "push-pull" (double compartment core) osmotic system wherein the core of the OROS ® system is replaced by a pull compartment containing a sparingly soluble drug composition and a push compartment containing water soluble osmotically active agents.
  • the two compartments are separated by means of an elastic diaphragm.
  • the osmotic pressure that builds up in the push compartment causes an increase in its volume. This increase in volume expands the elastic diaphragm, which thereby forces the drug out of the pull compartment through an aperture.
  • PCT application WO 9806380 discloses "push-pull" osmotic dosage forms providing ascending drug release rates comprising a trilayer core composition; consisting of a first drug layer, a second drug layer, and a push layer.
  • U.S. Patent Application No. 20010012847 discloses "push-pull" osmotic dosage forms providing ascending drug release rates.
  • the dosage forms include one or more drug layer and a push layer wherein the different layers are compressed together to provide a longitudinally compressed tablet core having a "capsule - shaped" configuration with a different layer at each narrow end.
  • Such a compressed tablet core has the different layers compressed together along the longitudinal, width axis rather than the thickness axis.
  • Such an unconventional core configuration ensures that, as the push layer expands longitudinally within the compartment formed by the semipermeable membrane, the surface area of the push layer in contact with the semipermeable membrane is increased more than when other configurations are used.
  • an osmotic dosage form configured to dispense a drug at an ascending release rate.
  • the dosage form consists of a core, a semipermeable membrane, and at least one passageway.
  • the core has a longitudinal width dimension and a thickness dimension and includes a drug layer and a push layer. The drug layer and the push layer are joined along the thickness dimension.
  • the semipermeable membrane surrounds the core. The at least one passageway is in the semipermeable membrane.
  • Embodiments of the dosage form may include one or more of the following features.
  • the drug may be one or more of central nervous system stimulants, opioids, antidiabetics, antineoplastic agents, antihypertensives, hypnotics, barbiturates, psychostimulants, cannabinoids, catecholamines, cardiovascular agents, platelet aggregation inhibitors, analgesics, antimicrobials, diuretics, and spasmolytics.
  • the drug may be one or more of methylphenidate, amphetamines, glipizide, doxazosin, isradipine, nifedipine, nisoldipine, bendroflumethazide, chlorpropamide, hydrocortisone, ibuprofen, diclofenac, and oxycodone.
  • the drug may be dispensed at an ascending release rate for at least 4 hours.
  • the drug layer may further include polyethylene oxide having a molecular weight greater than 200,000.
  • the molecular weight may be, for example, between 300,000 and 600,000.
  • the push layer may include one or more of water swellable polymers, alginic acid and its derivatives or salts, water insoluble, water swellable copolymers produced by forming a dispersion of a finely divided copolymer of maleic anhydride with styrene, ethylene, propylene, butylene or isobutylene cross-linked with a saturated cross-linking agent of saturated cross-linking agent per mole of maleic anhydride in the copolymer, acidic carboxy polymers, polyacrylamides, cross-linked water swellable indenemaleic anhydride polymers, and polyacrylic acid.
  • water swellable polymers alginic acid and its derivatives or salts
  • water insoluble, water swellable copolymers produced by forming a dispersion of a finely divided copolymer of maleic anhydride with styrene, ethylene, propylene, butylene or isobutylene cross-linked with
  • the water swellable polymers may be one or more of polyethylene oxide, hydroxypropyl methylcellulose, and poly(hydroxy alkyl methacrylate).
  • the drug layer and/ or the push layer may be one or more of osmotic agents comprising magnesium chloride or magnesium sulfate, lithium chloride, sodium chloride, potassium chloride, lithium hydrogen phosphate, sodium hydrogen phosphate, potassium hydrogen phosphate, lithium dihydrogen phosphate, sodium dihydrogen phosphate, potassium dihydrogen phosphate, water soluble salts of organic acids, non ionic organic compounds with high water solubility, water-soluble amino acids, and urea and urea derivatives.
  • the water soluble salts of organic acids may be one or more of sodium acetate, potassium acetate, magnesium succinate, sodium benzoate, sodium citrate, and sodium ascorbate.
  • the non ionic organic compounds with high water solubility may be one or more carbohydrates.
  • the water-soluble amino acids may be one or more of glycine, leucine, alanine, and methionine.
  • the osmotic dosage form may further include one or more pharmaceutically acceptable inert excipients comprising osmotic agents, binders, diluents, surfactants, pH modifiers, lubricants/glidants, stabilizers, plasticizers, and coloring agents.
  • the semipermeable membrane may include one or more membrane forming polymers, including cellulose derivatives, polymeric epoxides, copolymers of alkylene oxides and alkyl glycidyl ethers, polyglycols or polylactic acid derivatives, and copolymers of acrylic acid ethyl ester or methacrylic acid methyl ester.
  • membrane forming polymers including cellulose derivatives, polymeric epoxides, copolymers of alkylene oxides and alkyl glycidyl ethers, polyglycols or polylactic acid derivatives, and copolymers of acrylic acid ethyl ester or methacrylic acid methyl ester.
  • the cellulose derivatives may be one or more of cellulose acetate, ethyl cellulose, cellulose triacetate, agar acetate, amylose acetate, cellulose acetate ethyl carbamate, cellulose acetate phthalate, cellulose acetate methyl carbamate, cellulose acetate succinate, cellulose acetate dimethylaminoacetate, cellulose acetate ethyl carbonate, cellulose acetate chloroacetate, cellulose acetate ethyl oxalate, cellulose acetate methyl sulphonate, cellulose acetate butyl sulphonate, cellulose acetate propionate, cellulose acetate diethylamino-acetate, cellulose acetate octate, cellulose acetate laurate, cellulose acetate p-toluenesulphonate, and cellulose acetate butyrate.
  • a process for the preparation of an osmotic dosage form configured to dispense a drug at an ascending release rate.
  • the process includes the steps of: (a) combining the components of a drug layer by blending of a drug with polyethylene oxide of molecular weight greater than 200,000, and at least one pharmaceutically acceptable inert excipient and optionally granulating the blend;
  • Step (c) combining the granules/ blends of Steps (a) and (b) and processing into a conventional bilayer core tablet, the core tablet have a longitudinal width dimension and a thickness dimension, the drug layer and the push layer being joined along the thickness dimension;
  • Embodiments of the process may include one or more of the following features or those described above.
  • either or both of the blends may be granulated using a wet granulation or dry granulation technique.
  • the drug layer further comprises polyethylene oxide having a molecular weight greater than 200,000.
  • a method of treating a condition in a mammal by administering to the mammal in need thereof an osmotic dosage form configured to dispense a drug at an ascending release rate.
  • the dosage form consists of a core, a semipermeable membrane, and at least one passageway.
  • the core has a longitudinal width dimension and a thickness dimension and includes a drug layer and a push layer.
  • the drug layer and the push layer are joined along the thickness dimension.
  • the semipermeable membrane surrounds the core.
  • the at least one passageway is in the semipermeable membrane.
  • Embodiments of the method may include one or more of the following features or those described above.
  • the drug may be one or more of central nervous system stimulants, opioids, antidiabetics, antineoplastic agents, antihypertensives, hypnotics, barbiturates, psychostimulants, cannabinoids, catecholamines, cardiovascular agents, platelet aggregation inhibitors, analgesics, antimicrobials, diuretics, and spasmolytics.
  • the drug layer may further include polyethylene oxide having a molecular weight greater than 200,000.
  • Figure 1 is a graphical representation of the cumulative in vitro release of the drug from the tablets of Examples 1 and 2.
  • Figure 2 is a graphical representation of the in vitro release rate of the drug from the tablet of Examples 1 and 2.
  • Figure 3 is a graphical representation of the cumulative in vitro release of the drug from the tablets of Examples 3 and 4.
  • Figure 4 is a graphical representation of the in vitro release rate of the drug from the tablet of Examples 3 and 4.
  • the core tablets may have a configuration of a conventional tablet, wherein the drug and push layers are placed along the thickness of the tablets.
  • a core tablet has a longitudinal, width axis or dimension and a thickness axis or dimension, the two layers are compressed together with a plane being formed along the thickness axis rather than, for example, the width or longitudinal axis.
  • osmotic dosage form has a drug layer and a push layer, wherein the drug layer includes of polyethylene oxide having high molecular weight, approximately greater than 200,000.
  • the in vitro release profile of the osmotic dosage forms thus developed has a gradually increasing release rate over time. This characteristic release rate is mainly attributed to the use of high molecular weight polyethylene oxide having a molecular weight hat is greater than approximately 200,000.
  • the present dosage forms can be prepared using simple conventional solid dosage form manufacturing techniques, avoiding the extra fabrication cost for the development of a core having more than two layers.
  • core covers any bilayer compact composition having at least one drug layer and push layer, with a defined shape such as tablet, mold, capsule and the like.
  • the drug layer may be made up of drug, polyethylene oxide of molecular weight greater than 200,000, and the push layer may be made up of one or more water swellable polymers, in addition to an osmotic agent in one or both of the layers.
  • drug as used herein includes any drug for which an ascending release rate is desired or is of some benefit.
  • the drug may be in the form of pharmaceutically acceptable salts, solvates, enantiomers, ester, and mixtures thereof.
  • Suitable examples include drugs belonging to the class of central nervous system stimulants, opioids, antidiabetics, antineoplastic agents, antihypertensives, hypnotics, barbiturates, psychostimulants, cannabinoids, catecholamines, cardiovascular agents, platelet aggregation inhibitors, analgesics, antimicrobials, diuretics, and spasmolytics although other classes may be used as desired.
  • the drug constitutes from about 1% to about 50% of the drug layer by weight. In particular, it may constitute from about 3% to about 25% of the drug layer by weight.
  • Polyethylene oxide used in the drug layer is marketed by Dow under the trade name POLYOXTM. It is available in various grades depending on its molecular weight, which may range from greater than 200,000. In particular, the molecular weight of polyethylene oxide may vary from about 200,000 to about 8,000,000 and more particularly from about 200,000 to about 2,000,000.
  • suitable grades of polyethylene oxide that may be used in the drug layer include POLYOXTM WSR N-80 (MW - 200,000), WSR N-750 (MW - 300,000), WSR-205 (MW - 600,000), WSR-1105 (MW - 900,000), WSR N-12K (MW - 1,000,000), WSR N-60K (MW - 2,000,000), WSR-301 (MW - 4,000,000), WSR Coagulant (MW - 5,000,000), and WSR-303 (MW - 7,000,000).
  • the polyethylene oxide constitutes from about 20% to about 80% of the drug layer by weight. In particular, it may constitute from about 30% to about 60% of the drug layer by weight.
  • osmotic agent includes all pharmaceutically acceptable inert water soluble compounds suitable for inducing osmosis, referred to in the Pharmacoepias, or in “Hager” as well as in Remington's Pharmaceutical sciences.
  • Examples of compounds suitable as osmotic agents include water soluble salts of inorganic acids such as magnesium chloride or magnesium sulfate, lithium chloride, sodium chloride, potassium chloride, lithium hydrogen phosphate, sodium hydrogen phosphate, potassium hydrogen phosphate, lithium dihydrogen phosphate, sodium dihydrogen phosphate, and potassium dihydrogen phosphate; water soluble salts of organic acids such as sodium acetate, potassium acetate, magnesium succinate, sodium benzoate, sodium citrate, and sodium ascorbate; non ionic organic compounds with high water solubility, e.g., carbohydrates such as mannitol, sorbitol, arabinose, ribose, xylose, glucose, fructose, mannose, galactose, sucrose, maltose, lactose, and raffinose; water- soluble amino acids such as glycine, leucine, alanine, or methionine; urea and urea derivatives;
  • the composition of the push layer includes a water swellable polymer such as polyethylene oxide having a weight average molecular weight of 100,000 to 6,000,000, hydroxypropyl methylcellulose, poly(hydroxy alkyl methacrylate); poly(vinyl)alcohol, having a low acetal residue, which is cross-linked with glyoxal, formaldehyde or glutaraldehyde and having a degree of polymerization of from 200 to 30,000; a mixture of methyl cellulose, cross-linked agar and carboxymethyl cellulose; alginic acid and its derivatives/salts such as sodium alginate, and potassium alginate; a water insoluble, water swellable copolymer produced by forming a dispersion of a finely divided copolymer of maleic anhydride with styrene, ethylene, propylene, butylene or isobutylene cross-linked with saturated cross-linking agent of saturated cross-linking agent per mole of maleic anhydr
  • the pharmaceutically acceptable, water swellable polymers may be employed in an effective amount that will control the swelling of the push layer. These amounts will generally be from about 30% to 90%, preferably from about 40% to 75% based on the weight of the push layer.
  • the drug and push layer may further comprise one or more pharmaceutically acceptable inert excipients.
  • pharmaceutically acceptable inert excipients includes all excipients used in the art of manufacturing osmotic controlled dosage forms and described in the literature. Specific examples include binders, diluents, surfactants, pH modifiers, lubricants/glidants, stabilizers, plasticizers, coloring agents, and the like.
  • binders include methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinylpyrrolidone, gelatin, gum arabic, ethyl cellulose, polyvinyl alcohol, pullulan, pregelatinized starch, agar, tragacanth, sodium alginate, propylene glycol, and the like.
  • diluents include calcium carbonate, calcium phosphate- dibasic, calcium phosphate-tribasic, calcium sulfate, cellulose-microcrystalline, cellulose powdered, dextrates, dextrins, dextrose excipients, fructose, kaolin, lactitol, lactose, mannitol, sorbitol, starch, starch pregelatinized, sucrose, sugar compressible, sugar confectioners, and the like.
  • surfactants include both non-ionic and ionic (cationic, anionic and zwitterionic) surfactants suitable for use in pharmaceutical compositions. These include polyethoxylated fatty acids and its derivatives, for example polyethylene glycol 400 distearate, polyethylene glycol - 20 dioleate, polyethylene glycol 4 -150 mono dilaurate, polyethylene glycol -20 glyceryl stearate; alcohol - oil transesterification products, for example polyethylene glycol - 6 corn oil; polyglycerized fatty acids, for example polyglyceryl - 6 pentaoleate; propylene glycol fatty acid esters, for example propylene glycol monocaprylate; mono and diglycerides for example glyceryl ricinoleate; sterol and sterol derivatives; sorbitan fatty acid esters and its derivatives, for example polyethylene glycol - 20 sorbitan monooleate, sorbitan monolaurate; polyethylene
  • the pH modifiers are substances which help in maintaining the pH of the local environment surrounding the drug at a value favorable for dissolution of drug.
  • Specific examples of pH modifiers include dibasic sodium phosphate, sodium ascorbate, meglumine, sodium citrate, trimethanolamine, sodium hydroxide, potassium hydroxide, calcium hydroxide, magnesium oxide, magnesium hydroxide, ammonia, tertiary sodium phosphate, diethanolamine, ethylenediamine, L-lysine and the like.
  • lubricants/glidants include colloidal silicon dioxide, stearic acid, magnesium stearate, calcium stearate, talc, hydrogenated castor oil, sucrose esters of fatty acid, microcrystalline wax, yellow beeswax, white beeswax, and the like.
  • plasticizers include acetylated triacetin, triethylcitrate, tributylcitrate, glyceroltributyrate, monoglyceride, rape oil, olive oil, sesame oil, acetyltributylcitrate, acetyltriethylcitrate, glycerin sorbitol, diethyloxalate, diethyl phthalate, diethylmalate, diethylfumarate, dibutylsuccinate, diethylmalonate, dioctylphthalate, dibutylsebacate, and the like.
  • Stabilizers include antioxidants, buffers, acids, and the like. Coloring agents include any FDA approved colors for oral use.
  • Semipermeable membrane is a membrane or coating, which allows movement of water molecules through it, but does not allow contents of the core to pass through.
  • Semipermeable membrane comprises membrane forming polymers and other pharmaceutically acceptable coating additives.
  • Membrane forming polymers are those which are not metabolized in the gastrointestinal tract, i.e., are ejected unchanged from the body in feces.
  • Membrane forming polymers include those known in the art for fabrication of semipermeable membrane and described in the literature, e.g., in U.S. Patent Nos. 3,916, 899 and 3,977,404.
  • semipermeable membrane forming polymers include cellulose derivatives such as cellulose acetate, ethyl cellulose, cellulose triacetate, agar acetate, amylose acetate, cellulose acetate ethyl carbamate, cellulose acetate phthalate, cellulose acetate methyl carbamate, cellulose acetate succinate, cellulose acetate dimethylaminoacetate, cellulose acetate ethyl carbonate, cellulose acetate chloroacetate, cellulose acetate ethyl oxalate, cellulose acetate methyl sulphonate, cellulose acetate butyl sulphonate, cellulose acetate propionate, cellulose acetate diethylamino-acetate, cellulose acetate octate, cellulose acetate laurate, cellulose acetate p-toluenesulphonate, and cellulose acetate butyrate; polymeric epoxides; copo
  • Controlling membrane thickness also helps to control the permeability of the membrane, which generally may vary from about 3% to about 25% weight build up over the weight of the bilayered core tablet.
  • coating additives includes all conventional coating additives used in the art of coating technology and described in the literature. Examples include flux enhancers as well as those described above under pharmaceutically acceptable inert excipients.
  • Flux enhancers are water soluble substances which aid in drawing water from the surrounding media and are thereby helpful in manipulating the semipermeable membrane's permeability. Specific examples include hydroxymethyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol, hydroxypropylcellulose, propylene glycol, polyvinylpyrrolidone, and the like.
  • passageway covers any suitable means for releasing the contents of the core into the surrounding media.
  • the term includes passages, apertures, bores, holes, openings and the like, that are created through the semipermeable membrane and form a connection between the core and the surrounding media.
  • the passageway may be created by mechanical drilling or laser drilling, or formed in response to the osmotic pressure acting on the drug delivery system. Based on the nature of the desired drug release profile, the number and diameter of the passageways may be adjusted. However, the diameter of the passageway should not be large enough to allow body fluids to enter the drug delivery system by the process of convection.
  • the bilayer core of the osmotic dosage form may be prepared by combining the granule or blend compositions of the drug and the push layers.
  • the process for the preparation of a bilayered core of osmotic dosage form that dispenses drug at an ascending release rate includes the steps of: (a) Combining the components of the drug layer by blending of a drug with polyethylene oxide of molecular weight greater than 200,000, binder, and other pharmaceutically acceptable inert excipient and; optionally granulating the blend; (b) Combining the components of the push layer by blending of at least one water swellable polymer with one or more pharmaceutical acceptable excipients and; optionally granulating the blend; and (c) Combining the granules/ blends of steps (a) and (b) and processing into a conventional bilayer core tablet.
  • the granules in any of the above embodiments may be prepared using dry or wet granulation techniques.
  • the osmotic dosage prepared in any of the above embodiments may be further coated with a coating composition comprising a solution / dispersion of the semipermeable membrane a forming polymer, plasticizers and optionally other coating additives.
  • the semipermeable layer may be applied using conventional coating techniques well known in the art such as spray coating in a conventional coating pan, or fluidized bed processor, dip coating, melt coating, and the like. In particular a spray coating technique may be used.
  • granulating fluids or solvents for preparing the solution/dispersion of coating composition include aqueous or organic solvents, and mixtures thereof such as water, methanol, ethanol, isopropyl alcohol, dichloromethane, acetone and the like.
  • the osmotic dosage prepared in any of the above embodiments may further be processed to form at least one passageway in the semipermeable membrane using a 0.8 mm mechanical drill.
  • the osmotic dosage form further may be coated with an immediate release layer of drug.
  • the drug in the immediate release layer may be same or different from the drug present in the drug layer surrounded by semipermeable membrane.
  • step 2 The melted mixture of step 1 was cooled to form a solid mass.
  • step 3 The solid mass of step 2 was crushed and sized through a # 44 sieve (BSS) to provide co-processed doxazosin.
  • BSS # 44 sieve
  • the ingredients of the push layer were blended and sized through a #22 sieve (BSS).
  • step 1 and 2 were compressed into conventional bilayered core tablets.
  • the bilayered core tablets were coated with the semipermeable membrane- forming coating solution of cellulose acetate and polyethylene glycol, up to a weight gain of about 12-14%. 2.
  • An orifice (0.6 to 0.8 mm) was drilled through the semipermeable membrane towards the drug layer using mechanical drill.
  • the ingredients of the push layer were blended and sized through a #22 sieve (BSS).
  • step 1 and 2 were compressed into conventional bilayered core tablets using standard round concave punches.
  • the bilayered core tablets were coated with the semipermeable membrane-forming coating solution of cellulose acetate and polyethylene glycol, until reading a weight gain of about 7-10%. 2.
  • An orifice (0.8-10 mm) was drilled through the semipermeable membrane towards the drug layer using mechanical drill.
  • an osmotic core composition comprising methylphenidate
  • the core may be surrounded by a semipermeable membrane, and an optional immediate release layer of methylphenidate, and one or more passageways may be drilled through the semipermeable membrane.
  • the osmotic dosage form thus formed would provide an optional immediate dose of methylphenidate followed by ascending release rate of methylphenidate delivery.
  • An osmotic dosage form of methylphenidate that dispenses methylphenidate at an ascending release rate may have the following composition ranges.

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Abstract

L'invention porte sur des formes posologiques osmotiques à taux croissant de libération du médicament, et sur leurs procédés de préparation.
PCT/IB2005/003183 2004-10-25 2005-10-25 Formes posologiques osmotiques a taux croissant de liberation du medicament, et leurs procedes de preparation WO2006046114A2 (fr)

Applications Claiming Priority (2)

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IN2081/DEL/2004 2004-10-25
IN2081DE2004 2004-10-25

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7419684B2 (en) 2006-12-22 2008-09-02 Reliant Pharmaceuticals, Inc. System and method for manufacturing oral osmotic drug delivery devices, and methods of administering same
US8956654B2 (en) 2009-06-02 2015-02-17 Dow Global Technologies Llc Sustained release dosage form
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
CN106560177A (zh) * 2015-09-30 2017-04-12 深圳翰宇药业股份有限公司 一种曲格列汀药物组合物及其制备方法
WO2017115328A1 (fr) 2015-12-31 2017-07-06 Cadila Healthcare Limited Forme pharmaceutique osmotique à libération prolongée comprenant une charge est levée de chlorhydrate de méthylphénidate
US9707184B2 (en) 2014-07-17 2017-07-18 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US10195153B2 (en) 2013-08-12 2019-02-05 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US10959958B2 (en) 2014-10-20 2021-03-30 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form

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US4765989A (en) * 1983-05-11 1988-08-23 Alza Corporation Osmotic device for administering certain drugs
US5024843A (en) * 1989-09-05 1991-06-18 Alza Corporation Oral hypoglycemic glipizide granulation
US5160744A (en) * 1991-06-27 1992-11-03 Alza Corporation Verapmil therapy
US5713852A (en) * 1995-06-07 1998-02-03 Alza Corporation Oral dosage and method for treating painful conditions of the oral cavity
NZ508567A (en) * 1998-06-03 2004-02-27 Alza Corp Methods and devices for providing prolonged drug therapy
UA81224C2 (uk) * 2001-05-02 2007-12-25 Euro Celtic S A Дозована форма оксикодону та її застосування
WO2006030402A2 (fr) * 2004-09-17 2006-03-23 Ranbaxy Laboratories Limited Dispositif d'administration osmotique a deux compartiments

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7419684B2 (en) 2006-12-22 2008-09-02 Reliant Pharmaceuticals, Inc. System and method for manufacturing oral osmotic drug delivery devices, and methods of administering same
US8956654B2 (en) 2009-06-02 2015-02-17 Dow Global Technologies Llc Sustained release dosage form
US10195153B2 (en) 2013-08-12 2019-02-05 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US10639281B2 (en) 2013-08-12 2020-05-05 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US10792254B2 (en) 2013-12-17 2020-10-06 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US9707184B2 (en) 2014-07-17 2017-07-18 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
US10959958B2 (en) 2014-10-20 2021-03-30 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
CN106560177A (zh) * 2015-09-30 2017-04-12 深圳翰宇药业股份有限公司 一种曲格列汀药物组合物及其制备方法
WO2017115328A1 (fr) 2015-12-31 2017-07-06 Cadila Healthcare Limited Forme pharmaceutique osmotique à libération prolongée comprenant une charge est levée de chlorhydrate de méthylphénidate
US20180360817A1 (en) * 2015-12-31 2018-12-20 Cadila Healthcare Limited Extended release osmotic dosage form comprising high methylphenidate hydrochloride load

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