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2U11/148243 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 1 /1 1 December 2011 (01.12.2011) 2U11/148243 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 9/20 (2006.01) A61K 31/428 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, (21) International Application Number: CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, PCT/IB20 11/001099 DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, 23 May 201 1 (23.05.201 1) KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (25) Filing Language: English NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, (26) Publication Langi English SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 567/KOL/2010 24 May 2010 (24.05.2010) IN (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant (for all designated States except US): LUPIN GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, LIMITED [IN/IN]; 159 CST Road, Kalina, Santacruz ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, (East), State of Maharashtra, 400 098 Mumbai (IN). TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, (72) Inventors; and LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, (75) Inventors/ Applicants (for US only): KULKARNI, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, Shirishkumar [IN/IN]; Lupin Limited (Research Park), GW, ML, MR, NE, SN, TD, TG). 46A/47A, Village Nande, Taluka Mulshi, Maharashtra, 4 11 042 Pune (IN). KULKARNI, Rajesh [IN/IN]; Lupin Declarations under Rule 4.17 : Limited (Research Park), 46A/47A, Village Nande, Talu — as to applicant's entitlement to apply for and be granted ka Mulshi, Maharashtra, 4 11 042 Pune (IN). JADHAV, a patent (Rule 4.1 7(H)) Pandharinath [IN/IN]; Lupin Limited (Research Park), 46A/47A, Village Nande, Taluka Mulshi, Maharashtra, — as to the applicant's entitlement to claim the priority of 4 11 042 Pune (IN). TIWARI, Ashish [IN/IN]; Lupin the earlier application (Rule 4.17(Hi)) Limited (Research Park), 46A/47A, Village Nande, Talu — of inventorship (Rule 4.1 7(iv)) ka Mulshi, Maharashtra, 4 11 042 Pune (IN). Published: (74) Agents: MAJUMDAR, Subhatosh et al; S. Majumdar & Co., 5, Harish Mukherjee Road, 700 025 Kolkata (IN). — with international search report (Art. 21(3)) (54) Title: EXTENDED RELEASE FORMULATION OF PRAMIPEXOLE (57) Abstract: An extended release formulation comprising pramipexole or pharmaceutically acceptable salts; derivatives; sol vates; and isomers thereof, a weak acid and an extended release polymer. The formulation provides pH independent release profile of pramipexole. EXTENDED RELEASE FORMULATION OF P A IPEXOLE Field of the Invention The present invention is directed to an extended release formulation of anti- parkinsonism drug comprising pramipexole or pharmaceutically acceptable salts; derivatives; solvates; and isomers thereof, a weak acid and an extended release polymer. Background of the Invention Parkinson's disease is a movement disorder of increasing occurrence in aging populations. It is a progressive neurodegenerative disorder affecting the mobility and control of the skeletal muscular system. The disease is associated with the depletion of dopamine from cells in the corpus striatum. Parkinson's disease is a common disabling disease of old age affecting about one percent of the population over the age of 60 in the United States. The incidence of parkinson's disease increases with age and the cumulative lifetime risk of an individual developing the disease is about 1 in 40. Symptoms include pronounced tremor of the extremities, bradykinesia, rigidity and postural change. A perceived pathophysiological cause of Parkinson's disease is progressive destruction of dopamine-producing cells in the basal ganglia which comprise the pars compartum of the substantia nigra, basal nuclei located in the brain stem. Loss of dopamineric neurons results in a relative excess of acetylcholine. Parkinson's disease often begins with mild limb stiffness and infrequent tremors and progresses over a period of ten or more years to frequent tremors and memory impairment, to uncontrollable tremors and dementia. Based on the mechanism the anti-parkinson's drugs can be classified as dopamine precursors or prodrugs, dopamine receptor agonists, monoamine oxidase-B inhibitors, catechol-O-methyl transferase inhibitors, aromatic L-amino acid decarboxylase inhibitors, anticholinergics, N-methyl D-aspartate receptor inhibitors etc. Drugs such as etilevodopa; droxidopa; levodopa; melevodopa; aplindore; apomorphine bromocriptine; cabergoline; dihydroergocryptine; lisuride; pardoprunox; pergolide; piribedil; pramipexole; ropinarole; rotigotine; ladostigil lazabemide; mofegiline; pargyline; rasagiline; selegiline; entacapone; tolcapone; benserazide; carbidopa; methyldopa; benzatropine; biperiden; bornaprine; chlorphenxamine; cyrimine; dexetimide; dimenhydrinate; diphenylhydramine; etanautine; etybenzatropine; mazaticol; metixene; orphenadrine; phenglutarimide; piroheptine; procyclidine; profenamine; trihexyphenidyl; tropatepine; amantadine; budipine; memantine; rimantadine and the like are used for the treatment of parkinson's disease. Most common adverse events in early parkinson's disease without levodopa were somnolence, nausea, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and peripheral edema. Pramipexole is a non-ergot dopamine agonist with high relative in vitro specificity and full intrinsic activity at the D2 subfamily of dopamine receptor, binding with higher affinity to D3 than D2 or D subtypes. The precise mechanism of action of pramipexole as a treatment for parkinson's disease is unknown, although it is believed to be related to its ability to stimulate dopamine receptors in the striatum. This conclusion is supported by electrophysiologic studies in animals that have demonstrated that pramipexole influences striatal neuronal firing rates via activation of dopamine receptors in the striatum an the substantia nigra, the site of neurons that send projections to the striatum. The relevance of D3 receptor binding in parkinson's disease is unknown. The pramipexole is a basic drug and its chemical name is (S)-2-amino-4, 5,6,7- tetrahydro-6-(propylamino) benzothiazole. Its empirical formula is C10H17N3S. The salt form commonly used is pramipexole dihydrochloride monohydrate. The pramipexole as its dihydrochloride monohydrate salt is approved in United States as MIRAPEX ® (immediate release tablets) and as MIRAPEX®ER (extended release tablets) for the treatment of early as well as advanced idiopathic parkinson's disease. MIRAPEX® is also approved for the treatment of moderate-to-severe primary restless legs syndrome (RLS). MIRAPEX ®ER tablets are taken orally once daily. US 4,886,812 discloses tetrahdro-benzthiazole compounds (pramipexole). US6, 001 ,861 & US 6,194,445 disclose use of pramipexole for the treatment of restless legs syndrome. The starting dose of pramipexole is 0.375 mg/day. Based on efficacy and tolerability, dosages may be increased gradually, not more frequently than every 5 to 7 days, first to 0.75 mg/day and then by 0.75mg increments up to a maximum recommended dose of 4.5 mg/day. As is commonly known, extended release of active ingredient(s) allows simplification of the patient's administration scheme by reducing the amount of recommended daily intakes, improves patient's compliance, and attenuates adverse events, e.g., related to high plasma peaks. Extended release pharmaceutical preparations regulate the release of the incorporated active ingredient or ingredients over time and comprise formulations with controlled, prolonged, sustained, delayed, slow or an extended release, so they accomplish therapeutic or convenience objectives not offered by conventional dosage forms such as solutions or promptly dissolving dosage forms. There are a number of approaches described in prior art to provide extended release tablet compositions of pramipexole. US 7,695,734 discloses an extended release tablet formulation comprising pramipexole or a pharmaceutically acceptable salt thereof in a matrix comprising at least two water swelling hydrophilic polymers other than pregelatinized starch, and wherein at least one of the at least two polymers is an anionic polymer and the other is a substantially neutral polymer. US 2005/0175691 discloses the orally deliverable pharmaceutical once daily sustained release composition comprising a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof , a starch preferably pregelatinized starch, a hydrophilic polymer such as hydroxypropylmethyl cellulose and at least one pharmaceutically acceptable excipient. US 2005/0226926 discloses a sustained-release pharmaceutical composition in a form of an orally deliverable tablet comprises a water soluble salt of pramipexole dispersed in a matrix comprising a hydrophilic polymer and a starch having a tensile strength of at least about 0. 5 N cm 2 at a solid fraction representative of the tablet. US 2009/0281 153 discloses an
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