WO2005051350B1 - Water dispersible tablet - Google Patents

Water dispersible tablet

Info

Publication number
WO2005051350B1
WO2005051350B1 PCT/IN2004/000312 IN2004000312W WO2005051350B1 WO 2005051350 B1 WO2005051350 B1 WO 2005051350B1 IN 2004000312 W IN2004000312 W IN 2004000312W WO 2005051350 B1 WO2005051350 B1 WO 2005051350B1
Authority
WO
WIPO (PCT)
Prior art keywords
tablet
flavour
drug
pharmaceutically acceptable
prepared
Prior art date
Application number
PCT/IN2004/000312
Other languages
French (fr)
Other versions
WO2005051350A3 (en
WO2005051350A2 (en
Inventor
Vinod Kumar Gupta
Navin Vaya
Pramanick Sougata
Original Assignee
Torrent Pharmaceuticals Ltd
Vinod Kumar Gupta
Navin Vaya
Pramanick Sougata
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
Priority to IN1128/MUM/2003 priority Critical
Priority to IN1128MU2003 priority
Application filed by Torrent Pharmaceuticals Ltd, Vinod Kumar Gupta, Navin Vaya, Pramanick Sougata filed Critical Torrent Pharmaceuticals Ltd
Publication of WO2005051350A2 publication Critical patent/WO2005051350A2/en
Publication of WO2005051350A3 publication Critical patent/WO2005051350A3/en
Publication of WO2005051350B1 publication Critical patent/WO2005051350B1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
    • A61K31/53Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

This invention relates to a water dispersible formulation of an active pharmaceutical ingredient or pharmaceutically acceptable slat hereof and one or more adjuvants without the use of swellable clay. More particularly, the invention comprises a dispersible formulation of anti-epileptic drug - lamotrigine. This invention further relates to a process for the preparation of said formulation.

Claims

33
AMENDED CLAIMS
[received by the International Bureau on 04 August 2005 (04.08.05) ; original claims 1 and 3 amended ; original claims 22, 26 and 28 deleted ; remaining claims unchanged]
1. Water dispersible tablet comprising active pharmaceutical ingredient(s) or pharmaceutically acceptable salt thereof, and pharmaceutically acceptable exciepients or carriers, wherein pharmaceutically acceptable exciepients or carriers do not include swellable clay, further characterized in that the tablet upon dispersion yields particles 100% less than 600 microns and more than 50% less than 150 microns. 1. Tablet as claimed in claim 1, wherein the quantity of active pharmaceutical ingredient ranges between 10% - 60% w/w.
3. Water dispersible tablet comprising aπti- epileptic drug, more preferably lamotrigine as an active pharmaceutical ingredient(s) and pharmaceutically acceptable exciepients or carriers, wherein pharmaceutically acceptable exciepients or carriers do not include swellable clay, further characterized in that the tablet upon dispersion yields particles 100% less than 600 microns and more than 50% less than 1 0 microns 4. Tablet as claimed in claim 1 and 3, wherein pharmaceutically acceptable exciepients or carriers can be selected from disintegrart, binder, diluent, glidaπt, anti-adherent, lubricant, flavour and optionally dye.
5. Tablet as claimed in claim 1 and 3, wherein disintegraπts are selected from the group of cross-linked derivatives of cellulose and povidone and sodium starch, glycollate. 34
6. Tablet as claimed in claim 1 and 3, wherein diluents are selected from the group consisting of mannitot, microcrystalline cellulose and its co-processed derivatives with colloidal silicon dioxide or lactose, sugar, mannitol, Hydroxypropyicellulose (HPC), starch, and any combination thereof.
7. Tablet as claimed in claim 1 and 3, wherein colloidal silicon dioxide is used as a glidant or anti-adherent.
8. Tablet as claimed in claim 1 and 3, wherein lubricants are selected from the group consisting of alkaline metal stearates, sodium stearyl fumarate and talc.
9. Tablet as claimed in claim 1 and 3, wherein flavour is selected from the group consisting of black currant flavour, strawberry flavour, raspberry flavour, banana flavour, mint flavour, lemon flavour, peach flavour, and mixed fruit flavour.
10. Tablet as claimed in claim 1 and 3, wherein a lake dye is used as colorant
11. Tablet as claimed in claim 1 and 3, wherein quantity of croscaπnellose sodium ranges between 0.5% and 6% w/w and more preferably 1% and 5% wΛv.
12. Tablet as claimed in claim 1 and 3, wherein quantity of crospovidone ranges between 0.5% and 6% w/w and more preferably 1% and 5% w/w.
13. Tablet as claimed in claim 1 and 3, wherein quantity of sodium starch glycollate ranges between 1% and 10% w/w and more preferably 3% and 8% w/w.
14. Tablet as claimed in claim 1 and 3 , wherein quantity of microcrystalline cellulose or its co-processed derivatives ranges between 5% and 70% w/w and more preferably 10% and 60% w/w.
15. Tablet as claimed in claim 1 and 3, wherein the said microcrystalline cellulose or its co-processed derivatives have a mean particle size between 0 and 90 microns.
16. Tablet as claimed in claim 1 and 3, wherein quantity of colloidal silicon dioxide ranges between 0.5% and 5% w/w and more preferably 0.75% and 3% w w.
17. Tablet as claimed in claim 1, wherein tablet comprises 2 mg to 250 mg active pharmaceutical ingredient(s) or pharmaceutically acceptable salt thereof and
a. 10 to 60% w/w of mannitol or microcrystalline cellulose or its co-processed derivatives, b. 2 to 10% w/w of a binder from the group of starch and cellulose derivatives and polyvinyl pyrrolidone, c. 0.5 to 6% w w of crospovidone or croscarmellose, d. 1 to 10% w/w of sodium starch glycollate, e. 0.5 to 5% w w of colloidal silicon dioxide or silicic acid.
18. Tablet as claimed in claim 3, wherein tablet comprises 2 mg to 250 mg lamotrigine and a 10 to 60% w w of mannitol or microcrystalline cellulose or its co-processed derivatives, b. 2 to 5% w/w of a binder from the group of starch and cellulose derivatives and polyvinyl pyrrolidone, c. 0.5 to 6% w/w of crospovidone or croscarmellose, d. I to 10% w/w of sodium starch glycollate, e. 0.5 to 5% w/w of colloidal silicon dioxide or silicic acid.
19. Tablet as claimed in claim 1 and 3, wherein a water dispersible tablet is prepared by direct compression of drug granules prepared by granulation of the drug with adjuvants like diluents, binder, disintigrant(s), colorants, lubricants and flavouring agent 36
20. Tablet as claimed in claim I and 3, wherein a water dispersible tablet is prepared by direct compression of blend prepared by mixing the drug with all the other adjuvants like diluents, binder, disiπtigιant(s), colorants, lubricants and flavouring agent.
21. Tablet as claimed in claim 1 and 3, wherein a water dispersible tablet is prepared by direct compression of drug granules prepared by compaction of the drug with one or more adjuvants using a roller compactor followed by screening the drug granules and blending with other adjuvants like diluents, binder, disintigrant(s), colorants, lubricants and flavouring agert.
22. Tablet as claimed in claim 1, 3 and 18 releases greater than 85% of the of active drug within a period of 10 minutes in 900 ml of 0. IN HC1 stirred at 50 rpm in USP apparatus Type II.
23. Tablet as claimed in claim 1, 3, 17 and 18 releases greater than 85% of the labeled amount of active drug within a period of 10 minutes in 900 ml of pH 4.5 acetate buffer USP stirred at 50 rpm in USP apparatus Type II.
24. Tablet as claimed in claim 1, 3, 17 and 18 disintegrates within 3 minutes in accordance with the test for dispersible tablets as per British Pharmacopoeia 2001 , volume II.
25. Tablet as claimed in claim 1, 3, 17 and 1 may be prepared by wet or dry granulation.
PCT/IN2004/000312 2003-10-28 2004-10-07 Water dispersible tablet WO2005051350A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
IN1128/MUM/2003 2003-10-28
IN1128MU2003 2003-10-28

Publications (3)

Publication Number Publication Date
WO2005051350A2 WO2005051350A2 (en) 2005-06-09
WO2005051350A3 WO2005051350A3 (en) 2005-08-18
WO2005051350B1 true WO2005051350B1 (en) 2005-09-29

Family

ID=34631118

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2004/000312 WO2005051350A2 (en) 2003-10-28 2004-10-07 Water dispersible tablet

Country Status (1)

Country Link
WO (1) WO2005051350A2 (en)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007052289A2 (en) * 2005-07-22 2007-05-10 Rubicon Research Pvt Ltd. Novel dispersible tablet composition
US20070059360A1 (en) * 2005-07-29 2007-03-15 Ashish Jaiswal Water-dispersible anti-retroviral pharmaceutical compositions
GB0517205D0 (en) * 2005-08-22 2005-09-28 Novartis Ag Organic compounds
GB0518129D0 (en) * 2005-09-06 2005-10-12 Arrow Int Ltd Ramipril formulation
DE102005048293A1 (en) * 2005-10-08 2007-04-12 Sanofi-Aventis Deutschland Gmbh Sustained-release formulation for pralnacasan
CA2637240C (en) * 2006-01-18 2015-03-24 F. Hoffmann-La Roche Ag Pharmaceutical valatograst compositions and process for manufacturing same
US20100016322A1 (en) * 2007-02-28 2010-01-21 Nagesh Nagaraju Water Dispersible Pharmaceutical Formulation and Process for Preparing The Same
WO2009063484A2 (en) * 2007-08-03 2009-05-22 Alkem Laboratories Ltd Stable pharmaceutical composition of lamotrigine
MX2010003200A (en) 2007-09-25 2010-04-30 Teva Pharma Stable imatinib compositions.
EP3407874A1 (en) 2016-01-25 2018-12-05 KRKA, d.d., Novo mesto Fast dispersible pharmaceutical composition comprising tyrosine-kinase inhibitor
WO2018071547A1 (en) * 2016-10-11 2018-04-19 Aucta Pharmaceuticals Powder for oral suspension containing lamotrigine

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0181966A1 (en) * 1984-11-13 1986-05-28 Gist-Brocades N.V. Compression-coated dispersible tablets
GB8909793D0 (en) * 1989-04-28 1989-06-14 Beecham Group Plc Pharmaceutical formulation
GB9317146D0 (en) * 1993-08-18 1993-10-06 Wellcome Found Therapeutic combinations
US7939102B2 (en) * 2002-06-07 2011-05-10 Torrent Pharmaceuticals Ltd. Controlled release formulation of lamotrigine
WO2004103340A1 (en) * 2003-05-20 2004-12-02 Ranbaxy Laboratories Limited Water dispersible tablets of lamotrigine

Also Published As

Publication number Publication date
WO2005051350A3 (en) 2005-08-18
WO2005051350A2 (en) 2005-06-09

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