CA2405190A1 - Simethicone solid oral dosage form - Google Patents
Simethicone solid oral dosage form Download PDFInfo
- Publication number
- CA2405190A1 CA2405190A1 CA002405190A CA2405190A CA2405190A1 CA 2405190 A1 CA2405190 A1 CA 2405190A1 CA 002405190 A CA002405190 A CA 002405190A CA 2405190 A CA2405190 A CA 2405190A CA 2405190 A1 CA2405190 A1 CA 2405190A1
- Authority
- CA
- Canada
- Prior art keywords
- composition
- dosage form
- simethicone
- oral dosage
- solid oral
- 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
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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
Abstract
The present invention provides a composition for forming a compressed solid dosage form that is a free-flowing compressible admixture of simethicone, an adsorbent, and an optional active agent, wherein the weight ratio of simethicone to adsorbent is at least 1:2.22. Also included are solid dosage forms made from a free-flowing compressible admixture of simethicone, an adsorbent, and an optional active agent, wherein the weight ratio of simethicone to adsorbent is at least 1:2.22.
Claims (28)
1. A composition for forming a compressed solid dosage form comprising a free-flowing compressible admixture of simethicone and an adsorbent, wherein the weight ratio of simethicone to adsorbent is at least about 1:2.22.
2. A composition of claim 1, wherein the weight ratio of simethicone to adsorbent is at least about 1:2.00
3. A composition of claim 1, wherein the adsorbent comprises a combination of silicified microcrystalline cellulose and magnesium aluminometasilicate.
4. A composition of claim 1, further comprising at least one additional active agent.
5. A composition of claim 4, wherein the active agent is selected from the group consisting of bisacodyl, famotadine, prucalopride, diphenoxylate, loperamide, lactase, mesalamine, bismuth, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.
6. A composition of claim 5, wherein the active agent is loperamide, or pharmaceutically acceptable salts, esters, or isomers thereof.
7. A composition of claim 1 having at least 30 wt% simethicone.
8. A composition of claim 7, having from about 31 wt% to about 35 wt%
simethicone.
simethicone.
9. A composition of claim 1 having from about 19 wt% to about 27 wt%
silicified microcrystalline cellulose and having from about 31 wt% to about 39 wt% magnesium aluminometasilicate.
silicified microcrystalline cellulose and having from about 31 wt% to about 39 wt% magnesium aluminometasilicate.
10. A composition of claim 9 having from about 23 wt% to about 27 wt%
silicified microcrystalline cellulose and from about 33wt% to about 37 wt%
magnesium aluminometasilicate.
silicified microcrystalline cellulose and from about 33wt% to about 37 wt%
magnesium aluminometasilicate.
11. A composition of claim 1, wherein the composition is compressed into a tablet having a hardness value of at least 2 kp/cm2.
12. A composition of claim 11, wherein the composition is compressed into a tablet having a hardness value of from about 5 to about 10 kp/cm~.
13. A solid oral dosage form comprising a compressed admixture of simethicone, silicified microcrystalline cellulose, and magnesium aluminometasilicate, wherein the simethicone is adsorbed on the silicified microcrystalline cellulose and magnesium aluminometasilicate.
14. A solid oral dosage form of claim 13, wherein the weight ratio of simethicone to adsorbent is at least 1:2.00.
15. A solid oral dosage form of claim 13, wherein the adsorbent comprises silicified microcrystalline cellulose and magnesium aluminometasilicate.
16. A solid oral dosage form of claim 13, further comprising at least one additional active agent.
17. A solid oral dosage form of claim 16, wherein the active agent is selected from the group consisting of bisacodyl, famotadine, prucalopride, diphenoxylate, loperamide, lactase, mesalamine, bismuth, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof..
18. A solid oral dosage form of claim 17, wherein the active agent is loperamide, or pharmaceutically acceptable salts, esters, or isomers thereof.
19. A solid oral dosage form of claim 13 having at least 30 wt% simethicone.
20. A solid oral dosage form of claim 19, having from about 31 wt% to about 35 wt% simethicone.
21. A solid oral dosage form of claim 13 having from about 19 wt% to about 27 wt% silicified microcrystalline cellulose and having from about 31 wt% to about 39 wt% magnesium aluminometasilicate.
22. A solid oral dosage form of claim 21 having from about 23 wt% to about 27 wt% silicified microcrystalline cellulose and from about 33wt% to about 37 wt% magnesium aluminometasilicate.
23. A solid oral dosage form of claim 13, wherein the composition is compressed into a tablet having a hardness value of at least 2 kp/cm2.
24 A solid oral dosage form of claim 13, wherein the composition is compressed into a tablet having a hardness value of from about 5 to about 10 kp/cm2.
25. A composition for forming a solid dosage form comprising a free-flowing compressible admixture of simethicone, silicified microcrystalline cellulose, magnesium aluminometasilicate.
26. A compressed solid dosage form comprising an admixture of simethicone, silicified microcrystalline cellulose, magnesium aluminometasilicate, wherein the weight ratio of simethicone to adsorbent is at least 1:2.00.
27. A composition of claim 5, wherein the active agent is bisacodyl, or pharmaceutically acceptable salts, esters, or isomers thereof.
28. A composition of claim 4, wherein the active agent is selected from the group consisting of acetaminophen, ibuprofen, naproxen, ketoprofen, cyclobenzaprine, meloxicam, rofecoxib, celecoxib, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/966,441 | 2001-09-28 | ||
US09/966,441 US7101573B2 (en) | 2001-09-28 | 2001-09-28 | Simethicone solid oral dosage form |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2405190A1 true CA2405190A1 (en) | 2003-03-28 |
CA2405190C CA2405190C (en) | 2010-11-09 |
Family
ID=25511414
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2405190A Expired - Fee Related CA2405190C (en) | 2001-09-28 | 2002-09-25 | Simethicone solid oral dosage form |
Country Status (18)
Country | Link |
---|---|
US (3) | US7101573B2 (en) |
EP (1) | EP1297825B1 (en) |
AR (1) | AR036700A1 (en) |
AT (1) | ATE296619T1 (en) |
AU (1) | AU2002301259C1 (en) |
BR (1) | BR0204001A (en) |
CA (1) | CA2405190C (en) |
CO (1) | CO5390073A1 (en) |
DE (1) | DE60204403T2 (en) |
DK (1) | DK1297825T3 (en) |
ES (1) | ES2243664T3 (en) |
HU (1) | HUP0203176A2 (en) |
MX (1) | MXPA02009570A (en) |
NZ (1) | NZ521657A (en) |
PL (1) | PL204141B1 (en) |
PT (1) | PT1297825E (en) |
RU (1) | RU2362569C2 (en) |
ZA (1) | ZA200207755B (en) |
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-
2001
- 2001-09-28 US US09/966,441 patent/US7101573B2/en not_active Expired - Lifetime
-
2002
- 2002-09-25 CA CA2405190A patent/CA2405190C/en not_active Expired - Fee Related
- 2002-09-26 ZA ZA200207755A patent/ZA200207755B/en unknown
- 2002-09-26 HU HU0203176A patent/HUP0203176A2/en unknown
- 2002-09-27 DK DK02256741T patent/DK1297825T3/en active
- 2002-09-27 DE DE60204403T patent/DE60204403T2/en not_active Expired - Lifetime
- 2002-09-27 ES ES02256741T patent/ES2243664T3/en not_active Expired - Lifetime
- 2002-09-27 EP EP02256741A patent/EP1297825B1/en not_active Expired - Lifetime
- 2002-09-27 AU AU2002301259A patent/AU2002301259C1/en not_active Ceased
- 2002-09-27 AT AT02256741T patent/ATE296619T1/en not_active IP Right Cessation
- 2002-09-27 PL PL356358A patent/PL204141B1/en unknown
- 2002-09-27 RU RU2002125821/15A patent/RU2362569C2/en not_active IP Right Cessation
- 2002-09-27 NZ NZ521657A patent/NZ521657A/en unknown
- 2002-09-27 MX MXPA02009570A patent/MXPA02009570A/en active IP Right Grant
- 2002-09-27 AR ARP020103669A patent/AR036700A1/en not_active Application Discontinuation
- 2002-09-27 CO CO02087102A patent/CO5390073A1/en not_active Application Discontinuation
- 2002-09-27 PT PT02256741T patent/PT1297825E/en unknown
- 2002-09-30 BR BR0204001-8A patent/BR0204001A/en not_active Application Discontinuation
-
2006
- 2006-07-28 US US11/460,741 patent/US7691409B2/en not_active Expired - Lifetime
-
2010
- 2010-02-03 US US12/699,129 patent/US20100135982A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
US7691409B2 (en) | 2010-04-06 |
AU2002301259C1 (en) | 2009-07-23 |
MXPA02009570A (en) | 2004-07-30 |
US20070196468A1 (en) | 2007-08-23 |
PL204141B1 (en) | 2009-12-31 |
CA2405190C (en) | 2010-11-09 |
US20100135982A1 (en) | 2010-06-03 |
ES2243664T3 (en) | 2005-12-01 |
PL356358A1 (en) | 2003-04-07 |
HU0203176D0 (en) | 2002-11-28 |
ZA200207755B (en) | 2004-03-26 |
US20030091624A1 (en) | 2003-05-15 |
AU2002301259B2 (en) | 2009-01-22 |
RU2002125821A (en) | 2004-03-27 |
DE60204403T2 (en) | 2006-05-04 |
DE60204403D1 (en) | 2005-07-07 |
EP1297825A1 (en) | 2003-04-02 |
NZ521657A (en) | 2004-05-28 |
BR0204001A (en) | 2003-09-16 |
ATE296619T1 (en) | 2005-06-15 |
HUP0203176A2 (en) | 2004-07-28 |
PT1297825E (en) | 2005-08-31 |
EP1297825B1 (en) | 2005-06-01 |
AR036700A1 (en) | 2004-09-29 |
RU2362569C2 (en) | 2009-07-27 |
US7101573B2 (en) | 2006-09-05 |
DK1297825T3 (en) | 2005-09-26 |
CO5390073A1 (en) | 2004-04-30 |
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