AR096725A1 - FORMULATION OF CHEATABLE TABLETS INCLUDED BY TADALAFIL OR ONE OF ITS ACCEPTABLE SALTS FROM THE PHARMACEUTICAL VIEWPOINT - Google Patents
FORMULATION OF CHEATABLE TABLETS INCLUDED BY TADALAFIL OR ONE OF ITS ACCEPTABLE SALTS FROM THE PHARMACEUTICAL VIEWPOINTInfo
- Publication number
- AR096725A1 AR096725A1 ARP140102395A ARP140102395A AR096725A1 AR 096725 A1 AR096725 A1 AR 096725A1 AR P140102395 A ARP140102395 A AR P140102395A AR P140102395 A ARP140102395 A AR P140102395A AR 096725 A1 AR096725 A1 AR 096725A1
- Authority
- AR
- Argentina
- Prior art keywords
- tablet
- tadalafil
- pharmaceutically acceptable
- chewable tablet
- starch
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 4
- 150000003839 salts Chemical class 0.000 title abstract 4
- IEHKWSGCTWLXFU-IIBYNOLFSA-N tadalafil Chemical compound C1=C2OCOC2=CC([C@@H]2C3=C([C]4C=CC=CC4=N3)C[C@H]3N2C(=O)CN(C3=O)C)=C1 IEHKWSGCTWLXFU-IIBYNOLFSA-N 0.000 title abstract 4
- 229960000835 tadalafil Drugs 0.000 title abstract 4
- 238000009472 formulation Methods 0.000 title 1
- 239000007910 chewable tablet Substances 0.000 abstract 5
- 229940068682 chewable tablet Drugs 0.000 abstract 5
- 239000011230 binding agent Substances 0.000 abstract 3
- 239000008187 granular material Substances 0.000 abstract 3
- 239000003826 tablet Substances 0.000 abstract 3
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 abstract 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 abstract 2
- 229920002134 Carboxymethyl cellulose Polymers 0.000 abstract 2
- 229920002472 Starch Polymers 0.000 abstract 2
- 239000004480 active ingredient Substances 0.000 abstract 2
- 239000000654 additive Substances 0.000 abstract 2
- 230000000996 additive effect Effects 0.000 abstract 2
- 235000010443 alginic acid Nutrition 0.000 abstract 2
- 239000000783 alginic acid Substances 0.000 abstract 2
- 229920000615 alginic acid Polymers 0.000 abstract 2
- 229960001126 alginic acid Drugs 0.000 abstract 2
- 150000004781 alginic acids Chemical class 0.000 abstract 2
- 239000011575 calcium Substances 0.000 abstract 2
- 229910052791 calcium Inorganic materials 0.000 abstract 2
- 235000010948 carboxy methyl cellulose Nutrition 0.000 abstract 2
- 239000001768 carboxy methyl cellulose Substances 0.000 abstract 2
- 239000008112 carboxymethyl-cellulose Substances 0.000 abstract 2
- 229940105329 carboxymethylcellulose Drugs 0.000 abstract 2
- 239000007884 disintegrant Substances 0.000 abstract 2
- 235000010413 sodium alginate Nutrition 0.000 abstract 2
- 239000000661 sodium alginate Substances 0.000 abstract 2
- 229940005550 sodium alginate Drugs 0.000 abstract 2
- 229920003109 sodium starch glycolate Polymers 0.000 abstract 2
- 239000008109 sodium starch glycolate Substances 0.000 abstract 2
- 229940079832 sodium starch glycolate Drugs 0.000 abstract 2
- 239000008107 starch Substances 0.000 abstract 2
- 229940032147 starch Drugs 0.000 abstract 2
- 235000019698 starch Nutrition 0.000 abstract 2
- 239000001856 Ethyl cellulose Substances 0.000 abstract 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 abstract 1
- 108010010803 Gelatin Proteins 0.000 abstract 1
- 229920000084 Gum arabic Polymers 0.000 abstract 1
- 229920000881 Modified starch Polymers 0.000 abstract 1
- 239000000205 acacia gum Substances 0.000 abstract 1
- 235000010489 acacia gum Nutrition 0.000 abstract 1
- 235000019325 ethyl cellulose Nutrition 0.000 abstract 1
- 229920001249 ethyl cellulose Polymers 0.000 abstract 1
- MJEMIOXXNCZZFK-UHFFFAOYSA-N ethylone Chemical compound CCNC(C)C(=O)C1=CC=C2OCOC2=C1 MJEMIOXXNCZZFK-UHFFFAOYSA-N 0.000 abstract 1
- 229920000159 gelatin Polymers 0.000 abstract 1
- 239000008273 gelatin Substances 0.000 abstract 1
- 235000019322 gelatine Nutrition 0.000 abstract 1
- 235000011852 gelatine desserts Nutrition 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
Classifications
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Gynecology & Obstetrics (AREA)
- Reproductive Health (AREA)
- Pulmonology (AREA)
- Endocrinology (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
Abstract
Reivindicación 1: Un comprimido masticable que comprende: gránulos que contienen tadalafil o una de sus sales aceptables desde el punto de vista farmacéutico como principio activo; por lo menos un desintegrante seleccionado del grupo que consiste en almidón glicolato de sodio, carboximetil celulosa de calcio, almidón, ácido algínico, y alginato de sodio; y un aditivo aceptable desde el punto de vista farmacéutico. Reivindicación 3: El comprimido masticable de la reivindicación 2, en donde el aglutinante es un aglutinante no hidrofílico seleccionado del grupo que consiste en almidón pregelatinizado, goma acacia, gelatina, etil celulosa, y una de sus mezclas. Reivindicación 4: El comprimido masticable de la reivindicación 2, en donde el aglutinante está comprendido en una cantidad de 0,1 a 10% en peso, en base al peso total del comprimido. Reivindicación 5: El comprimido masticable de la reivindicación 1, en donde tadalafil o una de sus sales aceptables desde el punto de vista farmacéutico está comprendido en una cantidad de 1 a 15% en peso, en base al peso total del comprimido. Reivindicación 14: Un método para fabricar un comprimido masticable que comprende los pasos de: (1) preparar gránulos que contienen tadalafil o una de sus sales aceptables desde el punto de vista farmacéutico como principio activo; (2) mezclar los gránulos preparados en el paso (1) con por lo menos un desintegrante seleccionado del grupo que consiste en almidón glicolato de sodio, carboximetil celulosa de calcio, almidón, ácido algínico, y alginato de sodio, y un aditivo aceptable desde el punto de vista farmacéutico; y (3) formar el comprimido con la mezcla obtenida en el paso (2).Claim 1: A chewable tablet comprising: granules containing tadalafil or a pharmaceutically acceptable salt thereof as active ingredient; at least one disintegrant selected from the group consisting of sodium starch glycolate, calcium carboxymethyl cellulose, starch, alginic acid, and sodium alginate; and a pharmaceutically acceptable additive. Claim 3: The chewable tablet of claim 2, wherein the binder is a non-hydrophilic binder selected from the group consisting of pregelatinized starch, acacia gum, gelatin, ethyl cellulose, and one of mixtures thereof. Claim 4: The chewable tablet of claim 2, wherein the binder is comprised in an amount of 0.1 to 10% by weight, based on the total weight of the tablet. Claim 5: The chewable tablet of claim 1, wherein tadalafil or a pharmaceutically acceptable salt thereof is comprised in an amount of 1 to 15% by weight, based on the total weight of the tablet. Claim 14: A method of manufacturing a chewable tablet comprising the steps of: (1) preparing granules containing tadalafil or a pharmaceutically acceptable salt thereof as an active ingredient; (2) Mix the granules prepared in step (1) with at least one disintegrant selected from the group consisting of sodium starch glycolate, calcium carboxymethyl cellulose, starch, alginic acid, and sodium alginate, and an acceptable additive from the pharmaceutical point of view; and (3) form the tablet with the mixture obtained in step (2).
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR20130076093 | 2013-06-28 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR096725A1 true AR096725A1 (en) | 2016-01-27 |
Family
ID=52142275
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP140102395A AR096725A1 (en) | 2013-06-28 | 2014-06-25 | FORMULATION OF CHEATABLE TABLETS INCLUDED BY TADALAFIL OR ONE OF ITS ACCEPTABLE SALTS FROM THE PHARMACEUTICAL VIEWPOINT |
Country Status (4)
| Country | Link |
|---|---|
| KR (1) | KR102239291B1 (en) |
| AR (1) | AR096725A1 (en) |
| TW (1) | TWI663990B (en) |
| WO (1) | WO2014209022A1 (en) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20160138796A (en) | 2015-05-26 | 2016-12-06 | 삼아제약 주식회사 | Novel fast disintegrating fine granule formulation containing tadalafil as an active ingredient |
| JP2019065006A (en) * | 2017-09-29 | 2019-04-25 | ハンミ ファーマシューティカルズ カンパニー リミテッド | Solid preparation containing tadalafil with improved productivity and uniformity, and method for producing the same |
| CN110638768B (en) * | 2019-10-25 | 2024-04-16 | 株洲千金药业股份有限公司 | Preparation method of medicine for treating male erectile dysfunction |
| US20240299292A1 (en) * | 2020-12-01 | 2024-09-12 | Seattle Gummy Company | Stable semi-solid chewable gel compositions and methods of making and using thereof |
| WO2023227185A1 (en) * | 2022-05-27 | 2023-11-30 | Rontis Hellas S.A. | Improved pharmaceutical composition containing tadalafil and nanomilling process for the preparation thereof |
| CN114948886B (en) * | 2022-06-16 | 2023-08-01 | 南京正科医药股份有限公司 | Tadalafil orally disintegrating tablet and preparation method thereof |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GT199900061A (en) | 1998-05-15 | 2000-10-14 | Pfizer | PHARMACEUTICAL FORMULATIONS. |
| MXPA00003997A (en) | 1999-04-30 | 2002-03-08 | Lilly Icos Llc | Articles of manufacture. |
| KR100344198B1 (en) | 1999-10-08 | 2002-07-19 | 일양약품주식회사 | Composition of sildenafil citrate dosage form |
| WO2007039075A2 (en) * | 2005-09-29 | 2007-04-12 | Bayer Healthcare Ag | Pde inhibitors and combinations thereof for the treatment of urological disorders |
| CA2634019A1 (en) * | 2005-12-20 | 2007-06-28 | Pfizer Products Inc. | Pharmaceutical combination for the treatment of luts comprising a pde5 inhibitor and a muscarinic antagonist |
| US20090098211A1 (en) * | 2007-04-25 | 2009-04-16 | Ilan Zalit | Solid dosage forms |
| WO2009074995A1 (en) | 2007-12-10 | 2009-06-18 | Ajanta Pharma Limited | Taste masked chewable compositions of sildenafil citrate |
| WO2011030351A2 (en) * | 2009-09-03 | 2011-03-17 | Rubicon Research Private Limited | Taste - masked pharmaceutical compositions |
| US20110263606A1 (en) | 2010-04-26 | 2011-10-27 | Horst Zerbe | Solid oral dosage forms comprising tadalafil |
| WO2012120522A1 (en) | 2011-03-04 | 2012-09-13 | Genepharm India Private Limited | A taste masked chewable tablet of sildenafil |
-
2014
- 2014-05-28 KR KR1020140064385A patent/KR102239291B1/en active Active
- 2014-06-25 WO PCT/KR2014/005653 patent/WO2014209022A1/en not_active Ceased
- 2014-06-25 AR ARP140102395A patent/AR096725A1/en unknown
- 2014-06-27 TW TW103122328A patent/TWI663990B/en not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| KR20150002453A (en) | 2015-01-07 |
| TWI663990B (en) | 2019-07-01 |
| WO2014209022A1 (en) | 2014-12-31 |
| KR102239291B1 (en) | 2021-04-14 |
| TW201534355A (en) | 2015-09-16 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| ECSP18090046A (en) | NEW PIPERIDINYL DERIVATIVES SUBSTITUTED WITH HETERO (ARYL), A PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM | |
| AR096725A1 (en) | FORMULATION OF CHEATABLE TABLETS INCLUDED BY TADALAFIL OR ONE OF ITS ACCEPTABLE SALTS FROM THE PHARMACEUTICAL VIEWPOINT | |
| ECSP17082825A (en) | NEW HYDROXIACID DERIVATIVES, A PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM | |
| ECSP18090144A (en) | NEW PIPERIDINYL DERIVATIVES, A PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM | |
| CO2017012786A2 (en) | New hydroxy ester derivatives, a process for their preparation and pharmaceutical compositions containing them | |
| ECSP17083003A (en) | NEW BICYCLIC DERIVATIVES, A PROCESS FOR THEIR PREPARATION AND THE PHARMACEUTICAL COMPOSITIONS CONTAINING THEM | |
| CO2018007443A2 (en) | New ammonium derivatives, a process for their preparation and pharmaceutical compositions containing them | |
| CU20140081A7 (en) | NEW DERIVATIVES OF PIRROL, ITS PREPARATION PROCEDURE AND THE PHARMACEUTICAL COMPOSITIONS CONTAINING THEM | |
| ECSP17082546A (en) | NEW AMINO ACID DERIVATIVES, A PROCESS FOR THEIR PREPARATION AND THE PHARMACEUTICAL COMPOSITIONS THAT CONTAIN THEM | |
| CO7210068A1 (en) | New thienopyrimidine derivatives, a process for their preparation and pharmaceutical compositions containing them | |
| ECSP18023286A (en) | NEW DERIVATIVES OF PIRROLO [2,3-d] PYRIMIDINE, A PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM | |
| EA201891099A1 (en) | 7- (TIAZOL-5-IL) Pyrrolopyrimide as an agonist of the TLR7 receptor | |
| CU20140095A7 (en) | NEW PHOSPHATE DERIVATIVES, ITS PREPARATION PROCEDURE AND THE PHARMACEUTICAL COMPOSITIONS CONTAINING THEM | |
| AR090126A1 (en) | COMPOSITION OF DOXYLAMINE AND PYRIDOXINE AND / OR ITS METABOLITES OR SALTS | |
| EA201690679A1 (en) | STABLE PHARMACEUTICAL COMPOSITION CONTAINING AMLODIPIPIN AND VALSARTAN | |
| CR20160084A (en) | DERIVATIVES OF AMIDA AS AGONISTS OF THE LISOPHOSPHATIDIC ACID RECEPTOR | |
| PH12015502632A1 (en) | Cxcr7 receptor modulators | |
| CL2016001094A1 (en) | Microporous zirconium silicate for the treatment of hyperkalemia. | |
| PE20142460A1 (en) | IMMEDIATE RELEASE ORAL STABLE PHARMACEUTICAL COMPOSITIONS CONTAINING PRASUGREL | |
| ECSP21024078A (en) | NEW AMINO-PYRIMIDONIL-PIPERIDINYL DERIVATIVES, A PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM | |
| CL2016003047A1 (en) | Pharmaceutical composition comprising at least 150 mg and up to 700 mg of ceritinib and more than 40% and up to 70% by weight of ceritinib based on the weight of the composition comprising ceritinib granules and a binder; Tablet; tablet preparation process; and use of the pharmaceutical composition and the tablet. | |
| ECSP14013309A (en) | 2- (CROMAN-6-ILOXI)-REPLACED TAZOLS AND ITS USE AS PHARMACEUTICAL PRODUCTS | |
| UY35324A (en) | PHARMACEUTICAL COMPOSITIONS CONTAINING DEXKETOPROPHENE AND TRAMADOL | |
| IN2013MU02442A (en) | ||
| DOP2014000047A (en) | 2- (Croman-6-yloxy) -thiazoles substituted and their use as pharmaceuticals |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FB | Suspension of granting procedure |