EP0996466A2 - Nouvelle composition - Google Patents

Nouvelle composition

Info

Publication number
EP0996466A2
EP0996466A2 EP98946294A EP98946294A EP0996466A2 EP 0996466 A2 EP0996466 A2 EP 0996466A2 EP 98946294 A EP98946294 A EP 98946294A EP 98946294 A EP98946294 A EP 98946294A EP 0996466 A2 EP0996466 A2 EP 0996466A2
Authority
EP
European Patent Office
Prior art keywords
pharmaceutical composition
blocker
composition according
ssri
pindolol
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.)
Withdrawn
Application number
EP98946294A
Other languages
German (de)
English (en)
Inventor
Paul John-SmithKline Beecham Pharmaceut CUMMINGS
Ian Frederic-SmithKline Beecham Pharmace TULLOCH
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.)
SmithKline Beecham Ltd
Original Assignee
SmithKline Beecham 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 SmithKline Beecham Ltd filed Critical SmithKline Beecham Ltd
Publication of EP0996466A2 publication Critical patent/EP0996466A2/fr
Withdrawn legal-status Critical Current

Links

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
    • A61K9/2072—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32—Alcohol-abuse
    • 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
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

Definitions

  • This invention is concerned with novel formulations of selective serotonin re-uptake inhibitors (SSRI's).
  • SSRI's selective serotonin re-uptake inhibitors
  • the present invention provides formulations that potentiate the therapeutic activity of an SSRI, and especially that improve the onset of the therapeutic effect.
  • a problem with any co-administration regime is ensuring patient compliance, particularly in a regime such as proposed by Artigas which involves taking medication on three occasions during the day (assuming that the paroxetine dose and the first pindolol dose are taken simultaneously).
  • the present invention aims to overcome the problems associated with co-administration of SSRIs and potentiating compounds.
  • the present invention provides an SSRI composition
  • an SSRI composition comprising an SSRI in quick release form and a ⁇ -blocker in sustained release form.
  • the composition is conveniently in tablet or capsule form.
  • SSRIs used in this invention are paroxetine, fluvoxamine, citalopram and sertraline.
  • the SSRI is paroxetine.
  • the co-administered ⁇ -blocker is preferably pindolol.
  • the preferred combination of SSRI and ⁇ -blocker is paroxetine and pindolol.
  • the tablet or capsule contains 20 mg of paroxetine in an immediate release form and 7.5 mg of pindolol in a sustained release form.
  • the sustained release form of the ⁇ -blocker is provided to release the equivalent of a three times daily dose continuously over a period of 12-16 hours. Alternatively, the dose may be released in three spaced tranches.
  • the composition of the invention is preferably presented as a bi-layer tablet in which one layer contains an SSRI in a conventional quick release formulation and the other layer contains a ⁇ -blocker in a sustained release formulation.
  • the sustained release may be provided by formulating the ⁇ -blocker with any conventional sustained release excipient or blend of excipients that does not interact with the ⁇ -blocker or the SSRI.
  • the sustained release properties are provided by incorporating the ⁇ -blocker in an excipient which swells in gastric juice, typically forming a gel which dissolves and/or is abraded as the tablet passes through the patient's gut, releasing the active ingredient.
  • the rate of release may be controlled in a conventional manner by varying the molecular weight of the excipient and/or co-formulating a primary excipient with materials that dissolve or disintegrate at a different rate than the primary excipient, to form micropores in a swollen or gelled primary excipient.
  • Suitable primary excipients may be selected from swellable binders such as methyl cellulose for example as sold under the trade mark Methocel K4M and E5, ethyl cellulose, polyacrylic acid for example as sold under the trade mark Carbopol 974P, polyacrylic esters for example as sold under the trade mark Eudragit L30D and RS30D, xanthan gum, and starch.
  • swellable binders such as methyl cellulose for example as sold under the trade mark Methocel K4M and E5, ethyl cellulose, polyacrylic acid for example as sold under the trade mark Carbopol 974P, polyacrylic esters for example as sold under the trade mark Eudragit L30D and RS30D, xanthan gum, and starch.
  • the release profile of the primary excipient may be varied by incorporating fillers and disintegrants such as lactose especially lactose monohydrate, microcrystalline cellulose for example as sold under the trade mark Avicel pH102, calcium sulphate, dicalcium phosphate for example as sold under the trade mark Encompress, polyvinyl pyrrolidone for example as sold under the trade mark Povidone 30, hydrogenated vegetable oils for example as sold under the trade mark Lubritab.
  • lactose especially lactose monohydrate
  • microcrystalline cellulose for example as sold under the trade mark Avicel pH102
  • calcium sulphate for example as sold under the trade mark Encompress
  • polyvinyl pyrrolidone for example as sold under the trade mark Povidone
  • hydrogenated vegetable oils for example as sold under the trade mark Lubritab.
  • compositions may be a capsule presentation comprising coated pellets of a ⁇ -blocker, which is a mixture of coated pellets having different dissolution times, dispersed in a powder formulation of an SSRI, all contained within a soluble capsule.
  • the coating of the pellets of the ⁇ -blocker is a material that is resistant to gastric juices but dissolves in the gut, for example. Dissolution times may be varied by varying the coating thickness.
  • the coated pellets are mixed so as to provide a substantially continuous release of pindolol, but if desired the pellets may be a mixture of three coating thicknesses so that pindolol is released in three tranches over a the desired dosage period such as 12-14 hours.
  • a powdered formulation of the SSRI be be made by blending the SSRI with conventional excipients. Soluble capsules to contain the combination of active ingredients may be conventionally made from gelatine.
  • sustained release formulations of the above described hydrophilic matrix type and enteric coating type that may be used in this invention are disclosed in standard textbooks on the subject.
  • sustained release ⁇ -blocker formulation has a release profile measured in vitro in acid/buffer which has a dissolution time T 50 o /o of 1.73 hours, a T 90 o /o of 8.45 hours and a T 100 o /o of 14 hours.
  • a preferred embodiment of the invention provides a formulation of an SSRI and a ⁇ -blocker in which the ⁇ -blocker is in a sustained release form having a release profile in vitro in which the T 50 o /o is 1.73 hours ⁇ 20%, the T 90 o /o is 8.45 hours ⁇ 20% and the T 100 o /o is 14 hours ⁇ 20%.
  • the SSRI is paroxetine hydrochloride, most preferably at a dosage of 20 mg
  • the ⁇ -blocker is pindolol, most preferably at a dosage of 7.5 mg.
  • pindolol is typically used as the commercially available racemate. However, active isomers thereof may be used at a dosage adjusted for bioquivalence to a stated dose of the racemate.
  • compositions of this invention include treatment of alcoholism, anxiety, depression, obsessive compulsive disorder (OCD), panic disorder, chronic pain, obesity, senile dementia, migraine, bulimia, anorexia, social phobia, premenstrual syndrome (PMS), adolescent depression, trichotillomania, dysthymia and substance abuse; referred to herein as "the Disorders”.
  • the present invention also provides
  • a method for the treatment or prophylaxis of the Disorders which comprises administering a tablet or capsule comprising an SSRI and a sustained release form of a ⁇ - blocker to a person or animal in need thereof.
  • the tablet or capsule is preferably a composition of this invention having the preferred values indicated above.
  • Bi-layer tablets of paroxetine and sustained release pindolol were manufactured as follows.
  • a sustained release form of pindolol based upon a hydrophilic matrix with a soluble filler/disintegrant to increase the porosity of the matrix once hydrated was prepared by high shear wet granulation of a mixture of :
  • pindolol base 7.5 parts by weight methylcellulose (Methocel K4M) 35 parts by weight lactose monohydrate 25 parts by weight microcrystalline cellulose (Avicel pH 102) 32 parts by weight
  • paroxetine hydrochloride An immediate release formulation of paroxetine was prepared by blending 20 parts per weight of paroxetine hydrochloride and 80 parts per weight of conventional excipients.
  • 100 mg. amounts of the sustained release pindolol formulation were charged into tablet moulds in a rotary tableting platen at a first charging station. After a preliminary light pressing to locate the powdered formulation in the tablet mould, the platen was indexed to a second charging station where 152 mg. of the paroxetine formulation were introduced on top of the sustained release formulation. The two layer mixture in the tablet mould was then given a full press to prepare 252 mg. tablets containing 20 mg. paroxetine hydrochloride and 7.5 mg. pindolol in a sustained release base, each active component being in separate layers of a bi-layer tablet.

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Addiction (AREA)
  • Epidemiology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

On décrit une composition pharmaceutique comprenant un inhibiteur spécifique du recaptage de la sérotonine sous une forme à libération rapide et un béta-bloquant se présentant sous une forme à libération prolongée.
EP98946294A 1997-07-11 1998-07-07 Nouvelle composition Withdrawn EP0996466A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB9714675.7A GB9714675D0 (en) 1997-07-11 1997-07-11 Novel composition
GB9714675 1997-07-11
PCT/EP1998/004971 WO1999002142A2 (fr) 1997-07-11 1998-07-07 Nouvelle composition

Publications (1)

Publication Number Publication Date
EP0996466A2 true EP0996466A2 (fr) 2000-05-03

Family

ID=10815744

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98946294A Withdrawn EP0996466A2 (fr) 1997-07-11 1998-07-07 Nouvelle composition

Country Status (26)

Country Link
EP (1) EP0996466A2 (fr)
JP (1) JP2002508003A (fr)
KR (1) KR20010021644A (fr)
CN (1) CN1262627A (fr)
AP (1) AP2000001728A0 (fr)
AR (1) AR016128A1 (fr)
AU (1) AU9340198A (fr)
BG (1) BG104119A (fr)
BR (1) BR9810996A (fr)
CA (1) CA2295822A1 (fr)
CO (1) CO4950552A1 (fr)
DZ (1) DZ2556A1 (fr)
EA (1) EA200000112A1 (fr)
GB (1) GB9714675D0 (fr)
HU (1) HUP0003074A3 (fr)
ID (1) ID24191A (fr)
IL (1) IL133869A0 (fr)
MA (1) MA24604A1 (fr)
NO (1) NO20000107L (fr)
OA (1) OA11276A (fr)
PE (1) PE99699A1 (fr)
PL (1) PL338017A1 (fr)
SK (1) SK72000A3 (fr)
TR (1) TR200000074T2 (fr)
WO (1) WO1999002142A2 (fr)
ZA (1) ZA986138B (fr)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE457169T1 (de) 1998-10-15 2010-02-15 Imp Innovations Ltd Verbindungen für die behandlung von gewichtsverlust
EP1126826B3 (fr) 1998-11-02 2019-05-15 Alkermes Pharma Ireland Limited Composition de methylphenidate a liberation modifiee multiparticulaire
US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
AU764453B2 (en) 1999-10-29 2003-08-21 Euro-Celtique S.A. Controlled release hydrocodone formulations
GB0004003D0 (en) * 2000-02-22 2000-04-12 Knoll Ag Therapeutic agents
MXPA03003895A (es) 2000-10-30 2003-07-28 Euro Celtique Sa Formulaciones de hidrocodona de liberacion controlada.
AU2005283829A1 (en) * 2004-09-17 2006-03-23 Neurocure Ltd Pindolol for the treating premenstrual syndrome and premenstrual dysphoric disorder
CN100469356C (zh) * 2006-09-08 2009-03-18 山东益康药业有限公司 复方阿替洛尔缓释片及其制备方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2732335C2 (de) * 1976-07-27 1983-01-20 Sandoz-Patent-GmbH, 7850 Lörrach Tablette zur enteralen Verabreichung von Indolyloxyalkanolamin-Derivaten
CA2134038C (fr) * 1994-06-16 1997-06-03 David Taiwai Wong Potentialisation des effets de medicaments
EP0714663A3 (fr) * 1994-11-28 1997-01-15 Lilly Co Eli Potentialisation d'un médicament par un antagoniste du récepteur sérotonine 1A
ATE192042T1 (de) * 1995-08-16 2000-05-15 Lilly Co Eli Potenzierung von serotonin-wirkstoffresponz
EP0792649A1 (fr) * 1996-02-29 1997-09-03 Eli Lilly And Company Traitement de l'insomnie

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9902142A2 *

Also Published As

Publication number Publication date
TR200000074T2 (tr) 2000-05-22
CO4950552A1 (es) 2000-09-01
WO1999002142A3 (fr) 1999-04-15
NO20000107D0 (no) 2000-01-10
NO20000107L (no) 2000-01-10
DZ2556A1 (fr) 2003-02-15
EA200000112A1 (ru) 2000-10-30
BG104119A (en) 2000-12-29
AP2000001728A0 (en) 2000-03-31
MA24604A1 (fr) 1999-04-01
CN1262627A (zh) 2000-08-09
GB9714675D0 (en) 1997-09-17
IL133869A0 (en) 2001-04-30
CA2295822A1 (fr) 1999-01-21
PL338017A1 (en) 2000-09-25
OA11276A (en) 2003-07-31
JP2002508003A (ja) 2002-03-12
KR20010021644A (ko) 2001-03-15
SK72000A3 (en) 2000-12-11
ZA986138B (en) 2000-01-10
HUP0003074A2 (hu) 2001-01-29
AU9340198A (en) 1999-02-08
AR016128A1 (es) 2001-06-20
BR9810996A (pt) 2000-08-08
ID24191A (id) 2000-07-13
WO1999002142A2 (fr) 1999-01-21
PE99699A1 (es) 1999-12-21
HUP0003074A3 (en) 2001-12-28

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