WO2016042570A1 - Formulation à libération prolongée d'acétaminophène - Google Patents

Formulation à libération prolongée d'acétaminophène Download PDF

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Publication number
WO2016042570A1
WO2016042570A1 PCT/IN2014/000605 IN2014000605W WO2016042570A1 WO 2016042570 A1 WO2016042570 A1 WO 2016042570A1 IN 2014000605 W IN2014000605 W IN 2014000605W WO 2016042570 A1 WO2016042570 A1 WO 2016042570A1
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WO
WIPO (PCT)
Prior art keywords
acetaminophen
pharmaceutical composition
release
solid pharmaceutical
instamodel
Prior art date
Application number
PCT/IN2014/000605
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English (en)
Inventor
Suresh Pareek
Original Assignee
Suresh Pareek
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 Suresh Pareek filed Critical Suresh Pareek
Priority to PCT/IN2014/000605 priority Critical patent/WO2016042570A1/fr
Publication of WO2016042570A1 publication Critical patent/WO2016042570A1/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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders

Definitions

  • the present invention relates to a dry ready to use modified release dosage formulation for Acetaminophen dosage forms and its salts and derivatives thereof, a process for preparing extended release tablet using INSTAMODEL (A43D00050) manufactured by Ideal Cures Private Limited Mumbai India thereof also use thereof as additive to animal feeds, foods and food supplements and also cosmetic and pharmaceutical compositions.
  • Invention also relates to ready-to-use modified release compositions capable of regulating release of Acetaminophen at various dosage strength, a process for production thereof and also use thereof as formulated pharmaceutical compositions.
  • Acetaminophen is an analgesic and antipyretic agent which is widely used in prescription and non-prescription medicines, often in combination with other biologically active compounds.
  • the elimination half-life of Acetaminophen is reported to be in the range of 1.9-2.5 hours. Its absorption following oral doses of conventional immediate release tablets is characterized by passive absorption with high
  • Acetaminophen is administered through solid dosage ranges of 1000 mg every 4 to
  • modified release compositions are developed to provide relatively constant drug plasma levels and sustained efficacy for longer period of time.
  • Some prior art documents that disclose sustained release compositions of acetaminophen include US 4968509, WO 200180834 and WO 2004006904.
  • the aim of extended and modified release composition is to get required therapeutic concentration of the active in the blood stream and maintain its therapeutic concentration without deviation from strength during specified period.
  • cellulosic polymers are used in the modified release compositions e.g. HPMC polymer. These polymers extend the release of drug by showing osmosis nature in aqueous conditions.
  • Cellulosic matrix based system work by the swelling and gelling function i.e. these polymer swell through influx of liquids and a gel like physical structure is formed which provides extended release effect facilitated by diffusion of the acetaminophen.
  • WO 201 1026125, US 201 1212173 and US 2001014353 disclose use of cellulosic polymers for the modified release of drugs like acetaminophen.
  • the object of the present invention was to provide a ready-to-use matrix system and method of preparation for Acetaminophen extended release or modified release formulation.
  • the present invention provides hydrophilic matrix system based ready to use technology for Modified or Extended Release Formulation of Acetaminophen Hydrochloride using INSTAMODEL (A43D00050) manufactured by Ideal Cures Private Limited Mumbai India.
  • the present invention also provides method for making ready to use
  • Acetaminophen modified or extended release formulation involving steps of aqueous granulation, drying, lubrication and punching of tablets.
  • present invention also provides thrice or four times a day Acetaminophen table dosage form.
  • Extended release or modified release tablet formulation can be in the form of single or multilayer tablets, capsule shaped oral dosage form, caplet, granules, disc, pellets, granules in capsule, mini-tablets in oral dosage form and other possible oral dosage form mean thereof.
  • the solid oral dosage form can optionally include one or more pharmaceutically acceptable excipients.
  • the term 'modified release' is in context of the invention as a way of active drug delivery where the rate of release of the active drug from the composition is not exclusively dependent on the concentration of active drug remaining in the dosage form and / or the solubility of the active drug in the liquid surrounding the composition, and where the time course with or without respective location of release of active drug from an oral dosage form are chosen to accomplish therapeutic or convenience objectives not offered by conventional dosage forms.
  • active drug is selected from Aceclofenac, its intermediates and derivatives thereof.
  • the term 'Aceclofenac' is in context of the invention includes its polymorphic forms, the pharmaceutically acceptable salts, including salts esters and pother chemical derivatives or intermediates etc.
  • the solid pharmaceutical composition comprises Aceclofenac from 1 to 80 w/w % of dosage form.
  • the term 'dosage', 'solid pharmaceutical composition' may include one or more of tablet, capsule, powder, disc, caplet, granules, pellets, granules in capsule, minitablets, minitablets in capsule, pellets in capsule, sachet and the like.
  • the solid pharmaceutical composition also includes multilayer tablets. The solid pharmaceutical compositions are meant for oral administration.
  • tablette includes pharmaceutical compositions of all shapes and sizes, whether coated or uncoated.
  • Lubricant of present invention includes but not limited to talc, magnesium stearate, stearic acid, sodium stearyl fumarate and there derivatives thereof.
  • Glidant in the context of the present invention, is taken to mean that an ingredient which enhance product flow by reducing inter-particulate friction.
  • Glidant can be used in present invention includes but not limited to silicon di-oxide, colloidal silicon dioxide and there derivatives thereof. It is available under several brand names like AEROSIL® and CAB-O-SIL®.
  • Solvent' in the context of the present invention, is taken to mean ingredient that facilitate mixing of components in wet granulation process.
  • Solvent can be used in present invention includes but ri t limited to Acetone, ethanol, methylene di chloride, isopropyl alcohol, water or their mixture thereof.
  • 'Binder' or 'Binding agent' in the context of the present invention, is taken to mean ingredient that facilitate binding of components in wet granulation process.
  • Solvent can be used in present invention includes but not limited to dextrin and their derivatives, maltodextrin, polyvinyl polymers, Polyvinyl pyrrolidone 30 (PVP K30) and there derivatives thereof.
  • the ready to use composition in accordance with present invention comprise INSTAMODEL (A43D00045).
  • Aceclofenac is formulated with ready to use composition to prepare modified release dosage form.
  • different salts, derivatives, polymorphs of Aceclofenac could be combined to achieve ready-to-use composition to achieve extended or modified release dosage form.
  • Aceclofenac is blended with the ready to use polymer and aqueous granulated further the granulated mixtvire is compressed to produce a solid formulation.
  • the ingredients are blended to form a uniform powder and then compressed with means generally known to skilled in the art.
  • Aceclofenac and INSTAMODEL are blended together with binding agent and thereafter wet granulated and dried. These dried granules are then processed in presence of lubricant and glidant, and thereafter compressed to form appropriate dosage form and finally coated.
  • Aceclofenac and INSTAMODEL are blended together with binding agent and thereafter wet granulated and dried. These dried granules are then processed in presence of lubricant and glidant, and thereafter compressed to form appropriate dosage form and optionally coated.
  • Another advantage of the present formulation is its robust and reproducible results for extended release dose form without batch to batch variations. Further by using aqueous solvent system for granulation dosage form does not have any residual solvent or hazardous effect found in many organic solvent based formulations.
  • inventive dosage form may be prepared by blending Aceclofenac, their derivatives or combination thereof along with ready to use composition. Therefore inventive formulation preparation comprise steps as:-
  • the feature 'ready-to-use' in the context of the present invention, is taken to mean the property that the composition according to the invention can be used directly for its purposes by the user by simply dispersing it in required quantity of water.
  • the term 'modified release' is in context of the invention as a way of active drug delivery where the rate of release of the active drug from the composition is not exclusively dependent on the concentration of active drug remaining in the dosage form and / or the solubility of the active drug in the liquid surrounding the composition, and where the time course with or without respective location of release of active drug from an oral dosage form are chosen to accomplish therapeutic or convenience objectives not offered by conventional dosage forms.
  • active drug is selected from Acetaminophen, its intermediates and derivatives thereof.
  • the term 'Acetaminophen' is in context of the invention includes its polymorphic forms, the pharmaceutically acceptable salts, including salts esters and pother chemical derivatives or intermediates etc.
  • the solid pharmaceutical composition comprises Acetaminophen from 1 to 90 w/w % of dosage form.
  • the term 'dosage', 'solid pharmaceutical composition' may include one or more of tablet, capsule, powder, disc, caplet, granules, pellets, granules in capsule, minitablets, minitablets in capsule, pellets in capsule, sachet and the like.
  • the solid pharmaceutical composition also includes multilayer tablets. The solid pharmaceutical compositions are meant for oral administration.
  • tablette includes pharmaceutical compositions of all shapes and sizes, whether coated or uncoated.
  • Lubricant of present invention includes but not limited to talc, magnesium stearate, stearic acid, sodium stearyl fumarate and there derivatives thereof.
  • Glidant in the context of the present invention, is taken to mean that an ingredient which enhance product flow by reducing inter-particulate friction.
  • Glidant can be used in present invention includes but not limited to silicon di-oxide, colloidal silicon dioxide and there derivatives thereof. It is available under several brand names like AEROSIL® and CAB-O-SIL®.
  • Solvent' in the context of the present invention, is taken to mean ingredient that facilitate mixing of components in wet granulation process.
  • Solvent can be used in present invention includes but not limited to Acetone, ethanol, methylene di chloride, isopropyl alcohol, water or their mixture thereof.
  • 'Binder' or 'Binding agent' in the context of the present invention, is taken to mean ingredient that facilitate binding of components in wet granulation process.
  • Solvent can be used in present invention includes but not limited to dextrin and their derivatives, maltodextrin, polyvinyl polymers, Polyvinyl pyrrolidone 30 (PVP K30) and there derivatives thereof.
  • the ready to use composition in accordance with present invention comprise INSTAMODEL (A43D00050).
  • Acetaminophen is formulated with ready to use composition to prepare modified release dosage form.
  • different salts, derivatives, polymorphs of Acetaminophen could be combined to achieve ready-to-use composition to achieve extended or modified release dosage form.
  • Acetaminophen is blended with the ready to use polymer and aqueous granulated further the granulated mixture is compressed to produce a solid formulation.
  • the ingredients are blended to form a uniform powder and then compressed with means generally known to skilled in the art.
  • STAMODEL are blended together with binding agent and thereafter wet granulated and dried. These dried granules are then processed in presence of lubricant and glidant, and thereafter compressed to form appropriate dosage form and finally coated.
  • STAMODEL are blended together with binding agent and thereafter wet granulated and dried. These dried granules are then processed in presence of lubricant and glidant, and thereafter compressed to form appropriate dosage form and optionally coated.
  • Another advantage of the present formulation is its robust and reproducible results for extended release dose form without batch to batch variations. Further by using aqueous solvent system for granulation dosage form does not have any residual solvent or hazardous effect found in many organic solvent based formulations.
  • Inventive dosage form may be prepared by blending Acetaminophen, their
  • inventive formulation preparation comprise steps as:-
  • blending ready to use composition (Instamodel A43D00050)
  • process blending is performed by conventional dry blender or a food processor or 'V-blender' or a similar function device.
  • Acetaminophen are processed using aqueous solvent with binder through wet granulation or a similar wet mixing method to generate dosage formulation.
  • Dosage formulation is further dried, sieved and compressed optionally with addition of lubricant, binder, glidant to form modified release oral dosage form.
  • inventive dosage formulations are prepared by blending Acetaminophen along with Instamodel (A43D00050). Initially all components are blended by conventional dry blending in a food processor or 'V- blender' or a similar function device. Other solid oral dosage formulation components like binders, lubricants, glidants, detackifier, excipients can be added to create inventive formulation. Further mixture is then processed with appropriate quantity of aqueous solvent with binder and wet granulated. Obtained sieved granulated is then uniformly mixed with premeasured amount of the lubricant to improve industrial acceptability and oral dosage compression quality. Subsequently uniform mixed inventive formulation is compressed in standard pharmacopoeial equipment to get a controlled release oral dosage formulation of the correct desired weight and strength.
  • solid dosage formulation of Acetaminophen is prepared as in plurality of layers, including but not limited to more than one layers for example bi-layer solid oral dosage formulation, for which one or more layer is/are immediate release and other one or more layers are of extended release profile.
  • Immediate release layer of tablet is created using sifted Acetaminophen and micro- crystalline cellulose in rapid mixture granulator. Sifting is done using appropriate sieved for example through 20, 40 or 60 mesh screen. It is noted that other size screen could be used to get similar results. Sifted blend is then granulated using binding solution of PVP K30 and Purified water which were premixed till clear binding solution is formed and in rapid mixture granulator (RMG) . It is recommended that RMG should be at slow speed for some time followed by high speed. Granulation step requires proper optimization of water quantity and continuous monitoring to avoid heavy granulation. Generated wet mass is sieved using screen dried in tray drier at temperature not more than 50°C-65°C.
  • extended release profile layer are made by taking Acetaminophen with Instamodel optionally Colorant. Additionally binders can be added PVP K30 in rapid mixture granulator, all ingredients are sieved to get uniformly granulated powder through appropriate mesh screen. It is noted that other size screen could be used to get similar results. Sieved Acetaminophen with above ingredients is granulated using purified water as granulating solvent in rapid mixture granulator (RMG) . It is recommended that PJVIG should be at slow speed for 15 min followed by high speed for 3-5 mins.
  • RMG rapid mixture granulator
  • Silicon Dioxide are added to dry blended formulation in blender for subsequent 5 minutes.
  • immediate and extended release layers are then compressed in a way to form a bilayer shaped oral dosage form.
  • Immediate layer formulation granules are filled in one hopper of tablet compressing machine and punched in capsule shaped punches at an average weight of 395 mg. Further extended release granules are filled in another hopper of tablet compressing machine punched .
  • Generated dosage form tablets are then subjected to film coating using Instacoat Universal.
  • Both immediate and extended release layers are then compressed in a way to form a bilayer shaped oral dosage form.
  • Immediate layer formulation granules are filled I one hopper of tablet compressing machine and punched with 18.0 ⁇ 7.5 mm capsule shaped punches at an average weight of 395 mg and hardness NLT 4 Kg/cm 2 .
  • Further extended release granules are filled in another hopper of table compressing machine and set average weight of the final tablet at 820 mg and punched hardness of 8 - 10 Kg/cm 2 .
  • Final screened granules are compressed using 10.0 mm (for 300 mg average weight) circular, standard concave circular punches at hardness not less than 10- 15 kg/ cm 2 .
  • Generated dosage form tablets are then subjected to film coating using Instacoat Universal.
  • oral dosage forms produced by inventive composition having human administrable active ingredient is suitable for human use.
  • drug suitable for veterinary purpose formulated in accordance with present composition will be suitable for veterinary use.
  • Acetaminophen is formulated in oral dosage form for modified or extended release delivery.
  • Inventive composition comprising 500, 750, 820, 950 mg or 1000 mg of Acetaminophen in plurality of dosage formulations.
  • Controlled release formulation can have combination of one or more additional drugs.
  • Suitable APIs that can be used with the present invention include, but are not
  • andrenergic blocking agent acetyl-cholin-esterase inhibitor; analgesic or antipyretics; angiotensin modulator; anthelmintic agents; anti anxiety agent; antibacterial; antibiotic; anticoagulant; anticonvulsant; antidepressant; antifungal; antihistamine; antimalarial; antimicrobial agent; antipsychotic agent; Antiviral agents; blood glucose lowering drug; calcium channel modulator; diuretic; erectile dysfunction; gastric acid secretion inhibitor; histamine H2-receptor antagonist; inhibitor of steroid Type II 5[alpha]- reductase including; lipid regulating agents; selective Hl- receptor antagonist; vasodilator; vitamins.
  • the dosage formulation for 100,000 Tablets of Acetaminophen is prepared using composition as stated in table:- 1 and 2.
  • Present tables are prepared as bi-layer solid oral dosage formulation, for which one of the layer is immediate release and other layer is of extended release profile.
  • Granulation step requires proper optimization of water quantity and continuous monitoring to avoid heavy granulation. If required extra water can be added gradually under continuous observation (to avoid heavy wet mass). Generated wet mass is sieved using 4mm screen (Multi-mill/ Fitzmill) dried in tray drier (or Fluidized bed dryer) at temperature not more than 50°C-55°C keeping loss on drying at 1-2%.
  • 4mm screen Multi-mill/ Fitzmill
  • Both immediate and extended release layers are then compressed in a way to form a bilayer shaped oral dosage form.
  • Immediate layer formulation granules are filled I one hopper of tablet compressing machine and punched with 18.0 x 7.5 mm capsule shaped punches using Karnavati Tablet Compression M/C-17 Stn. GMP machine at an average weight of 395 mg and hardness NLT 4 Kg/cm 2 .
  • Further extended release granules are filled in another hopper of table compressing machine and set average weight of the final tablet at 820 mg and punched hardness of 8 - 10 Kg/cm 2 .
  • the drug dissolved profile of the Reference products and Acetaminophen having dose strength of 650 mg using Instamodel (A43D00050) formulations are compared.
  • the release exponents for the Reference and formulated Acetaminophen is found to be having similar modified release profile indicating a predominantly diffusion based drug release mechanism.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)

Abstract

La présente invention concerne une formulation pharmaceutique à libération modifiée, sèche, prête à l'usage pour des formes pharmaceutiques d'acétaminophène et ses sels et ses dérivés, un procédé de préparation de comprimé à libération prolongée utilisant INSTAMODEL (A43D00050) fabriqué par Ideal Cures Private Limited, Bombay, Inde de celui-ci ainsi que l'utilisation de celui-ci en tant qu'additif pour des aliments pour animaux, des aliments et des suppléments alimentaires et également des compositions cosmétiques et pharmaceutiques. L'invention concerne en outre des compositions à libération modifiée prêtes à l'usage capables de réguler la libération d'acétaminophène à différentes doses, un procédé de production de celles-ci et l'utilisation de celles-ci telles que des compositions pharmaceutiques formulées.
PCT/IN2014/000605 2014-09-16 2014-09-16 Formulation à libération prolongée d'acétaminophène WO2016042570A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IN2014/000605 WO2016042570A1 (fr) 2014-09-16 2014-09-16 Formulation à libération prolongée d'acétaminophène

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Application Number Priority Date Filing Date Title
PCT/IN2014/000605 WO2016042570A1 (fr) 2014-09-16 2014-09-16 Formulation à libération prolongée d'acétaminophène

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WO2016042570A1 true WO2016042570A1 (fr) 2016-03-24

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4820522A (en) * 1987-07-27 1989-04-11 Mcneilab, Inc. Oral sustained release acetaminophen formulation and process
WO2000013670A1 (fr) * 1998-09-03 2000-03-16 Ascent Pediatrics, Inc. Acetaminophene a liberation prolongee
WO2001080834A1 (fr) * 2000-04-19 2001-11-01 Smithkline Beecham P.L.C. Composition
WO2004006904A1 (fr) * 2002-07-16 2004-01-22 Seoul Pharm. Co., Ltd. Formes posologiques a liberation controlee administrees par voie orale contenant de l'acetaminophene

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4820522A (en) * 1987-07-27 1989-04-11 Mcneilab, Inc. Oral sustained release acetaminophen formulation and process
WO2000013670A1 (fr) * 1998-09-03 2000-03-16 Ascent Pediatrics, Inc. Acetaminophene a liberation prolongee
WO2001080834A1 (fr) * 2000-04-19 2001-11-01 Smithkline Beecham P.L.C. Composition
WO2004006904A1 (fr) * 2002-07-16 2004-01-22 Seoul Pharm. Co., Ltd. Formes posologiques a liberation controlee administrees par voie orale contenant de l'acetaminophene

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"Extended Release Tablets Formulation Simplified", IDEAL CURE PVT.LTD, 19 July 2012 (2012-07-19) *
HOSNA BANU ET AL.: "Formulation development of bi-layer acetaminophen tablets for extended drug release.", J.CHEM.PHARM.RES., vol. 3, no. 6, 2011, pages 348 - 360 *

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