CA2532648A1 - A stable clozapine suspension formulation - Google Patents

A stable clozapine suspension formulation Download PDF

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Publication number
CA2532648A1
CA2532648A1 CA002532648A CA2532648A CA2532648A1 CA 2532648 A1 CA2532648 A1 CA 2532648A1 CA 002532648 A CA002532648 A CA 002532648A CA 2532648 A CA2532648 A CA 2532648A CA 2532648 A1 CA2532648 A1 CA 2532648A1
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CA
Canada
Prior art keywords
composition
composition according
clozapine
addition
suspension
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.)
Granted
Application number
CA002532648A
Other languages
French (fr)
Other versions
CA2532648C (en
Inventor
Peter William Surman
Sharon Ferguson
Wai Bik Mak
Andrew Douglas Mcleod
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.)
Douglas Pharmaceuticals Ltd
Original Assignee
Douglas Pharmaceuticals Limited
Peter William Surman
Sharon Ferguson
Wai Bik Mak
Andrew Douglas Mcleod
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 Douglas Pharmaceuticals Limited, Peter William Surman, Sharon Ferguson, Wai Bik Mak, Andrew Douglas Mcleod filed Critical Douglas Pharmaceuticals Limited
Publication of CA2532648A1 publication Critical patent/CA2532648A1/en
Application granted granted Critical
Publication of CA2532648C publication Critical patent/CA2532648C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Psychiatry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

A physicochemically stable aqueous composition including clozapine suspensio n.

Claims (26)

1. A physicochemically stable aqueous composition including clozapine in suspension.
2. A physicochemically stable aqueous composition according to claim 1 together with a wetting agent, wherein the pH of the composition is maintained in the range of about 6 to about 11.
3. The composition according to claim 1 or 2 wherein the pH of the composition is maintained within the range of about 6 to about 11 using a buffer system.
4. The composition according to claim 3 wherein the buffer system is a sodium phosphate/sodium hydroxide buffer system.
5. The composition according to any one of the previous claims wherein the pH
is maintained in the range of from about 6 to about 8.
6. The composition according to any one of the previous claims wherein the amount of clozapine in the composition is from about 0.1% to about 10% by weight based on the total volume of the composition.
7. The composition according to any one of claims 2 to 6 wherein the wetting agent is present in an amount of between about 0.1% and about 15%.
8. The composition according to any one of claims 2 to 7 wherein the wetting agent is selected from any one or more of propylene glycol, glycerin, or polyethylene glycol.
9. The composition including according to any one of the previous claims including polyvinyl pyrrolidone (PVP).
10. The composition according to claim 9 wherein the PVP is present in an amount of between about 0.1% and 2.0% by weight based on the total volume of the composition.
11. The composition according to any one of the previous claims wherein the composition includes a suspending agent and/or a preservative.
12. The composition according to claim 11 wherein the suspending agent is present in an amount of between about 0.4% and about 2.0%.
13. The composition according to claim 11 wherein the preservative is present in an amount of between about 0.1% and about 0.5%.
14. The composition according to claims 11 or 12 wherein the suspending agent is xanthan gum.
15. The composition according to claim 11 or 13 wherein the preservative is a mixture of methyl, propyl and butyl parabens.
16. The composition according to any one of the previous claims wherein the composition further includes a sweetening agent and/or a flavouring substance.
17. The composition according to claims 1 or 2 wherein the composition includes:
clozapine, glycerine, sodium dihydrogen phosphate dihydrate/NaOH buffer, xanthan gum, methyl paraben, propyl paraben, butyl paraben, and water.
18. The composition according to claim 17 wherein the composition includes PVP.
19. A method for preparing a physicochemically stable aqueous composition including clozapine in suspension, the method including the step of controlling the pH of the formulation between about 6 and about 11.
20. The method according to claim 19 wherein the pH is controlled between 6 and 8.
21. The method according to claim 19, 20 or 21 wherein the method further includes the addition of PVP.
22. A method of producing a physicochemically stable aqueous composition including clozapine in suspension including the following steps:

(a) stirring the active ingredient clozapine with about three quarters of the propylene glycol ascribed to the batch;
(b) addition of the buffer salt (and optionally sweetening agents) dissolved in about half the volume of water ascribed to the batch with constant stirring;
(c) adjusting the pH value with the base component of the buffer with mixing;
(d) addition of the preservatives dissolved in the remaining propylene glycol;
(e) slow addition of the suspending agent with continuous stirring until the mixture thickens;
(f) further diluting the suspension with water to the desired end-volume.
23. A method for producing a physicochemically stable aqueous composition including clozapine in suspension including the following steps:
(a) stirring the active ingredient clozapine with about three quarters of the glycerine ascribed to the batch;
(b) addition of the buffer salt (and optionally sweetening agents) dissolved in about half the volume of water ascribed to the batch with constant stirring;
(c) adjusting the pH value with the base component of the buffer with mixing;
(d) addition of the preservatives dissolved in a small volume of water;
(e) slow addition of the suspending agent wetted with the remaining glycerine with continuous stirring until the mixture thickens;
(f) further diluting the suspension with water to the desired end-volume.
24. The method according to claims 22 or 23 wherein PVP is added as an aqueous solution following addition of the suspending agent.
25. A composition according to claim 1 substantially as herein described with reference to any one of the Examples.
26. A method according to claim 19 substantially as herein described with reference to any one of the Examples.
CA2532648A 2003-07-23 2004-07-22 A stable clozapine suspension formulation Active CA2532648C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
NZ527142A NZ527142A (en) 2003-07-23 2003-07-23 A stable suspension formulation
NZNZ527142 2003-07-23
PCT/NZ2004/000158 WO2005007168A1 (en) 2003-07-23 2004-07-22 A stable clozapine suspension formulation

Publications (2)

Publication Number Publication Date
CA2532648A1 true CA2532648A1 (en) 2005-01-27
CA2532648C CA2532648C (en) 2012-05-01

Family

ID=34075196

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2532648A Active CA2532648C (en) 2003-07-23 2004-07-22 A stable clozapine suspension formulation

Country Status (7)

Country Link
US (1) US8057811B2 (en)
EP (1) EP1646393B1 (en)
AU (1) AU2004257556C1 (en)
CA (1) CA2532648C (en)
ES (1) ES2436213T3 (en)
NZ (1) NZ527142A (en)
WO (1) WO2005007168A1 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ527142A (en) 2003-07-23 2006-03-31 Douglas Pharmaceuticals Ltd A stable suspension formulation
WO2007062339A2 (en) * 2005-11-18 2007-05-31 Astrazeneca Ab Liquid formulations
DE102006032427A1 (en) * 2006-07-13 2008-01-17 Neuraxpharm Arzneimittel Gmbh U. Co. Kg Use of composition comprising e.g. clozapine, quetiapine, olanzapine, benzyl- and/or phenylethyl alcohol, ethanol, ethereal oil, sweetener, and polyethylene glycol, for preparing an orally administering solution to treat schizophrenia
DE102006032426A1 (en) * 2006-07-13 2008-01-17 Neuraxpharm Arzneimittel Gmbh U. Co. Kg Use of a composition comprising e.g. clozapine and quetiapine; benzyl- and/or phenylethyl alcohol; propylene glycol; ethereal oil; and polyethylene glycol, for preparing an orally administering solution to treat schizophrenia
GB0907019D0 (en) * 2009-04-24 2009-06-03 Oxford Nutrascience Ltd Pharmaceutical,therapeutic or nutritional delivery systems for functional ingredients
US20130040939A1 (en) * 2009-09-10 2013-02-14 Bial - Portela & Ca, S.A. Oral Suspension Formulations of Esclicarbazepine Acetate
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WO2019068859A1 (en) 2017-10-06 2019-04-11 Leyden Technologies B.V. Stable solutions of multicyclic antidepressants

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GB2462611A (en) 2008-08-12 2010-02-17 Cambridge Lab Pharmaceutical composition comprising tetrabenazine

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EP1646393A1 (en) 2006-04-19
US20060240050A1 (en) 2006-10-26
WO2005007168A1 (en) 2005-01-27
ES2436213T3 (en) 2013-12-27
US8057811B2 (en) 2011-11-15
AU2004257556A1 (en) 2005-01-27
AU2004257556C1 (en) 2012-10-04
AU2004257556B2 (en) 2009-01-08
EP1646393B1 (en) 2013-09-04
CA2532648C (en) 2012-05-01
NZ527142A (en) 2006-03-31
EP1646393A4 (en) 2007-10-17

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