ECSP077881A - SOLID PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION OF IBANDRONIC ACID OR A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATION OF THE SAME, PROCEDURE FOR PREPARING SUCH COMPOSITION BY DIRECT COMPRESSION, PHARMACEUTICAL FORMULATIONS THAT - Google Patents
SOLID PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION OF IBANDRONIC ACID OR A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATION OF THE SAME, PROCEDURE FOR PREPARING SUCH COMPOSITION BY DIRECT COMPRESSION, PHARMACEUTICAL FORMULATIONS THATInfo
- Publication number
- ECSP077881A ECSP077881A ECSP077881A ECSP077881A EC SP077881 A ECSP077881 A EC SP077881A EC SP077881 A ECSP077881 A EC SP077881A EC SP077881 A ECSP077881 A EC SP077881A
- Authority
- EC
- Ecuador
- Prior art keywords
- composition
- preparing
- direct compression
- ibandronic acid
- pharmaceutically acceptable
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 5
- MPBVHIBUJCELCL-UHFFFAOYSA-N Ibandronate Chemical compound CCCCCN(C)CCC(O)(P(O)(O)=O)P(O)(O)=O MPBVHIBUJCELCL-UHFFFAOYSA-N 0.000 title abstract 3
- 238000007907 direct compression Methods 0.000 title abstract 3
- 229960005236 ibandronic acid Drugs 0.000 title abstract 3
- 239000000203 mixture Substances 0.000 title abstract 3
- 238000000034 method Methods 0.000 title abstract 2
- 150000003839 salts Chemical class 0.000 title abstract 2
- 239000007787 solid Substances 0.000 title abstract 2
- 230000036571 hydration Effects 0.000 title 1
- 238000006703 hydration reaction Methods 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 abstract 2
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 239000003085 diluting agent Substances 0.000 abstract 1
- 239000002552 dosage form Substances 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
La presente invención se refiere a una composición farmacéutica sólida en forma de dosificación unitaria para administración oral de ácido ibandrónico, obtenida mediante un proceso de compresión directa, que comprende 30 a 37% en peso de ácido ibandrónico o una sal o un hidrato farmacéuticamente aceptable del mismo, al menos un diluyente en una cantidad de aproximadamente 55 a 65% en peso, al menos un agente desintegrante en una cantidad de aproximadamente 0,5 a 1,5% en peso y al menos un lubricante en una cantidad de aproximadamente 4,5 a 5,5% en peso. La invención también comprende un proceso de compresión directa para preparar dichas composiciones así como las formulaciones farmacéuticas recubiertas que comprenden dichas composiciones y un proceso para preparar dichas formulaciones farmacéuticas recubiertas.The present invention relates to a solid pharmaceutical composition in unit dosage form for oral administration of ibandronic acid, obtained by a direct compression process, comprising 30 to 37% by weight of ibandronic acid or a pharmaceutically acceptable salt or hydrate of the same, at least one diluent in an amount of about 55 to 65% by weight, at least one disintegrating agent in an amount of about 0.5 to 1.5% by weight and at least one lubricant in an amount of about 4, 5 to 5.5% by weight. The invention also comprises a direct compression process for preparing said compositions as well as coated pharmaceutical formulations comprising said compositions and a process for preparing said coated pharmaceutical formulations.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ARP060104910 AR058512A1 (en) | 2006-11-09 | 2006-11-09 | SOLID PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION OF IBANDRONIC ACID OR A SALT OR A PHARMACEUTICALLY ACCEPTABLE HYDRATION OF THE SAME, PREPARATION PROCEDURE FOR THIS COMPOSITION BY DIRECT COMPRESSION, PHARMACEUTICAL FORMULATIONS THAT PREPARE AND PROCEDURE TO PREPARE |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ECSP077881A true ECSP077881A (en) | 2008-06-30 |
Family
ID=39059286
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ECSP077881 ECSP077881A (en) | 2006-11-09 | 2007-11-06 | SOLID PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION OF IBANDRONIC ACID OR A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATION OF THE SAME, PROCEDURE FOR PREPARING SUCH COMPOSITION BY DIRECT COMPRESSION, PHARMACEUTICAL FORMULATIONS THAT |
Country Status (9)
| Country | Link |
|---|---|
| AR (1) | AR058512A1 (en) |
| BR (1) | BRPI0704025A (en) |
| CL (1) | CL2007003210A1 (en) |
| CO (1) | CO5930065A1 (en) |
| DO (1) | DOP2007000134A (en) |
| EC (1) | ECSP077881A (en) |
| MX (1) | MX2007014056A (en) |
| PE (1) | PE20081343A1 (en) |
| UY (1) | UY30697A1 (en) |
-
2006
- 2006-11-09 AR ARP060104910 patent/AR058512A1/en unknown
-
2007
- 2007-11-06 EC ECSP077881 patent/ECSP077881A/en unknown
- 2007-11-06 PE PE2007001522A patent/PE20081343A1/en not_active Application Discontinuation
- 2007-11-07 CL CL2007003210A patent/CL2007003210A1/en unknown
- 2007-11-07 UY UY30697A patent/UY30697A1/en not_active Application Discontinuation
- 2007-11-08 CO CO07118248A patent/CO5930065A1/en not_active Application Discontinuation
- 2007-11-09 DO DO2007000134A patent/DOP2007000134A/en unknown
- 2007-11-09 MX MX2007014056A patent/MX2007014056A/en unknown
- 2007-11-09 BR BRPI0704025 patent/BRPI0704025A/en not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| CL2007003210A1 (en) | 2008-03-14 |
| UY30697A1 (en) | 2008-02-29 |
| BRPI0704025A (en) | 2008-07-01 |
| MX2007014056A (en) | 2009-02-19 |
| DOP2007000134A (en) | 2008-06-15 |
| CO5930065A1 (en) | 2008-06-27 |
| PE20081343A1 (en) | 2008-09-24 |
| AR058512A1 (en) | 2008-02-06 |
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| ECSP077881A (en) | SOLID PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION OF IBANDRONIC ACID OR A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATION OF THE SAME, PROCEDURE FOR PREPARING SUCH COMPOSITION BY DIRECT COMPRESSION, PHARMACEUTICAL FORMULATIONS THAT |