CN102743393A - Medicinal composition containing abiraterone acetate and preparation technology thereof - Google Patents
Medicinal composition containing abiraterone acetate and preparation technology thereof Download PDFInfo
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- CN102743393A CN102743393A CN2012102621017A CN201210262101A CN102743393A CN 102743393 A CN102743393 A CN 102743393A CN 2012102621017 A CN2012102621017 A CN 2012102621017A CN 201210262101 A CN201210262101 A CN 201210262101A CN 102743393 A CN102743393 A CN 102743393A
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- solid composite
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- acetic acid
- sodium lauryl
- lauryl sulphate
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Abstract
The invention belongs to the technical field of medicine, and particularly relates to a medicinal composition containing abiraterone acetate and a preparation technology of the medicinal composition. The medicinal composition comprises abiraterone acetate, a solubilizer, a binder and a disintegrating agent and can be prepared into tablets, granules or capsules. The invention is characterized in that the abiraterone acetate and hydrophilic auxiliary materials are crushed based on a proportion, and the dissolution rate and bioavailability of the medicine are effectively improved, the medicinal composition can be used for treating the prostate cancer.
Description
1, technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, concrete relate to a kind of pharmaceutical composition and preparation technology who contains the acetic acid abiraterone, belong to medical technical field.
2, background technology
The acetic acid abiraterone is a kind of oral cytochrome oxidase P450 (CYP450) c17 inhibitor; Through suppress androgen in synthetic key enzyme---CYP450c17 reduces the androgen level; And the androgen to testis and other positions of health all has inhibitory action, is used to treat advanced prostate cancer.Its structural formula is:
The acetic acid abiraterone is a lipophilic compound, is soluble in organic solvent such as oxolane, dichloromethane, particularly alcohols; 20 ℃ water-soluble hardly under the pH2-12 condition; Be slightly soluble in the hydrochloric acid of 0.1N, BCS classification belongs to four types, so carrying out improving its dissolution when pharmaceutical preparation is studied and bioavailability is a key of the present invention.
At present research worker can solve this problem through adopting Macrogol 4000 or 6000 etc. prepare method such as solid dispersion, but still can have the problem of less stable, complicated process of preparation.Also can adopt in addition to add surfactant in the prescription, insoluble drug added be dissolved in the micelle, the stripping that improves medicine by the solubilization of surfactant is like Tween80, glycerol or sodium lauryl sulphate etc.Surfactant is divided into cation active agent, anionic activating agent and nonionic agent; Because the toxic and side effects of cation active agent is bigger than nonionic and anionic, so be used as the many uses nonionic and the anionic activating agent of solubilizing agents for drugs.Wherein sodium lauryl sulphate is claimed sodium laurylsulfate (Sodium Lauryl Sulfate again; Be called for short SDS; SLS), be the mixture of alkyl sodium sulfate, mainly contain sodium lauryl sulphate, record in the current edition pharmacopeia, belong to anion surfactant.Surfactant as the conventional occupation mode of cosolvent is; Directly mix and/or join in the dissolution medium, be with the direct blended drawback of adjuvant, owing to the consumption of sodium lauryl sulphate is few with other adjuvants; Direct mixing can cause mixing inhomogeneous, thereby influences the quality of preparation.
3, summary of the invention
The present invention aims to provide a kind of solid composite medicament and preparation technology, contains the acetic acid abiraterone, and wherein the particle diameter of raw material control 0.1-50 μ m is preferably 0.1-20 μ m; Also contain other acceptable accessories in addition;
This solid composite that the present invention relates to; Be that acetic acid abiraterone and hydrophilicity condiment are carried out common pulverizing according to certain ratio; Mix homogeneously; Wherein said hydrophilicity condiment can be starch, pregelatinized Starch, mannitol, lactose, maltose, glucose etc., and the ratio of principal agent and hydrophilicity condiment is 1: 0.1～1: 1, and is preferably 1: 1;
The solid composite that the present invention relates to contains a kind of solubilizing agent, and this solubilizing agent is a sodium lauryl sulphate, and its consumption is 0.01%-3%, is preferably 1%, its adding mode for uniform mixing according to a certain percentage in binding agent;
The solid composite that the present invention relates to contains a kind of binding agent, and this binding agent is polyvinylpyrrolidone (PVP), and especially mean molecule quantity is higher than 2000, preferably is higher than 20000 water solublity PVP, for example K30, K90.Its concentration is 5%-15%, and is preferably 10%; Its consumption is 0.1%-10%, is preferably 2%-5%;
This compositions that the present invention relates to also comprises other adjuvants and comprises filler, disintegrating agent, lubricant etc.;
This compositions that the present invention relates to, filler can be one or more the mixture in the cellulose families such as saccharides such as lactose, glucose, starch, microcrystalline Cellulose, and its percentage by weight is 5～20%, and preferred 10～15%;
This compositions that the present invention relates to; Disintegrating agent can be enumerated as one or more the mixture in cellulose family, carboxymethyl starch sodium, the polyvinylpolypyrrolidone etc. such as cross-linking sodium carboxymethyl cellulose (CCMC-Na), low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, microcrystalline Cellulose, and its percentage by weight is 1%-10%;
This compositions that the present invention relates to, lubricant can be one or more the mixture in stearic acid and its metallic salt, Pulvis Talci, micropowder silica gel, the sucrose fatty acid ester etc.; Lubricant accounts for the 0.3%-2.0% of percentage by weight;
This compositions that the present invention relates to, and be preferably tablet, its preparation technology is:
With sodium lauryl sulphate and PVPK90 mix homogeneously, be dissolved in a certain amount of water and prepare adhesive; Microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose are crossed 80 mesh sieves, and acetic acid abiraterone and lactose are carried out common 100 mesh sieves of pulverizing; Press common powder thing, microcrystalline Cellulose, the cross-linking sodium carboxymethyl cellulose mix homogeneously of recipe quantity with acetic acid abiraterone and lactose; Add adhesive system soft material; Granulate with 18 mesh sieves; Oven dry, cross-linking sodium carboxymethyl cellulose, magnesium stearate and the silicon dioxide of adding recipe quantity behind the 24 mesh sieve granulate, tabletting promptly gets behind the mix homogeneously.
4, the specific embodiment
Below, foregoing of the present invention is done further to specify through the specific embodiment of embodiment form.But should this scope that is interpreted as the above-mentioned theme of the present invention only not limited to following examples.
The preparation of embodiment 1 acetic acid abiraterone sheet
Preparation technology: the acetic acid abiraterone that takes by weighing recipe quantity: lactose (1: 1), pulverize powder thing altogether, add recipe quantity microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose (in add) and cross 80 mesh sieve mixings.Above-mentioned mixed powder is placed dry grinding cup, add 5% the 30 POVIDONE K 30 BP/USP 90 aqueous solution system soft materials of the SDS that contains recipe quantity 0.1% in right amount, the granulation of 18 mesh sieves; Dry to moisture and be lower than 5%; 24 mesh sieve granulate add cross-linking sodium carboxymethyl cellulose, magnesium stearate and silicon dioxide, mixing; Tabletting promptly gets.
The preparation of comparative example 1-1 acetic acid abiraterone sheet
Preparation technology: take by weighing recipe quantity acetic acid abiraterone, lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose (in add) and cross 80 mesh sieve mixings.Above-mentioned mixed powder is placed dry grinding cup, adds an amount of 5% 30 POVIDONE K 30 BP/USP 90 aqueous solution system soft materials, the granulation of 18 mesh sieves is dried to moisture and is lower than 5%, 24 mesh sieve granulate, adding cross-linking sodium carboxymethyl cellulose, magnesium stearate and silicon dioxide, mixing; Tabletting promptly gets.
The preparation of comparative example 1-2 acetic acid abiraterone sheet
Preparation technology: the acetic acid abiraterone that takes by weighing recipe quantity: lactose (1: 1), pulverize powder thing altogether, add recipe quantity microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose (in add) and cross 80 mesh sieve mixings.Above-mentioned mixed powder is placed dry grinding cup, adds an amount of 5% 30 POVIDONE K 30 BP/USP 90 aqueous solution system soft materials, the granulation of 18 mesh sieves is dried to moisture and is lower than 5%, 24 mesh sieve granulate, adding cross-linking sodium carboxymethyl cellulose, magnesium stearate and silicon dioxide, mixing; Tabletting promptly gets.
The preparation of comparative example 1-3 acetic acid abiraterone sheet
Preparation technology: the acetic acid abiraterone, lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose (in add) that take by weighing recipe quantity are crossed 80 mesh sieve mixings.Above-mentioned mixed powder is placed dry grinding cup, add 5% the 30 POVIDONE K 30 BP/USP 30 aqueous solution system soft materials that contain recipe quantity SDS, 18 mesh sieves are granulated, and dry to moisture to be lower than 5%, 24 mesh sieve granulate, adding cross-linking sodium carboxymethyl cellulose, magnesium stearate and silicon dioxide, mixing; Tabletting promptly gets.
The preparation of comparative example 1-4 acetic acid abiraterone sheet
Preparation technology: the acetic acid abiraterone that takes by weighing recipe quantity: lactose (1: 1), pulverize powder thing altogether, add recipe quantity SDS, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose (in add) and cross 80 mesh sieve mixings.Above-mentioned mixed powder is placed dry grinding cup, add an amount of 5% 30 POVIDONE K 30 BP/USP 90 aqueous solution system soft materials, 18 mesh sieves are granulated, and dry to moisture to be lower than 5%, 24 mesh sieve granulate, adding cross-linking sodium carboxymethyl cellulose, magnesium stearate and silicon dioxide, mixing; Tabletting promptly gets.
The comparative study of embodiment 1-5 stripping curve
Measure the embodiment of the invention 1 and four acetic acid abiraterone sheets that the comparative example is prepared thereof; Be medium (reference fluid) with 900ml, 0.25%SDSpH4.5 phosphate buffer respectively; Rotating speed is 50rpm; Respectively at 5,10,15,30,45,60 minutes sampling test sample stripping curves, the result saw table 1:
Table 1 control formulation, embodiment and each comparative example stripping curve % (n=6) in the pH4.5PBS medium:
The preparation of embodiment 2 acetic acid abiraterone sheets
Preparation technology: the acetic acid abiraterone that takes by weighing recipe quantity: lactose (1: 1), pulverize powder thing altogether, add surplus lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose (in add) and cross 80 mesh sieve mixings.Above-mentioned mixed powder is placed dry grinding cup, add 5% the 30 POVIDONE K 30 BP/USP 90 aqueous solution system soft materials of the SDS that contains recipe quantity 0.1% in right amount, the granulation of 18 mesh sieves; Dry to moisture and be lower than 5%; 24 mesh sieve granulate add cross-linking sodium carboxymethyl cellulose, magnesium stearate and silicon dioxide, mixing; Tabletting promptly gets.
The preparation of embodiment 2-1 acetic acid abiraterone sheet
Preparation technology: the acetic acid abiraterone that takes by weighing recipe quantity: lactose (1: 1), pulverize powder thing altogether, add surplus lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose (in add) and cross 80 mesh sieve mixings.Above-mentioned mixed powder is placed dry grinding cup, add 5% the 30 POVIDONE K 30 BP/USP 90 aqueous solution system soft materials of the SDS that contains recipe quantity 0.1% in right amount, the granulation of 18 mesh sieves; Dry to moisture and be lower than 5%; 24 mesh sieve granulate add cross-linking sodium carboxymethyl cellulose, magnesium stearate and silicon dioxide, mixing; Tabletting promptly gets.
The dissolution comparative study of embodiment 2-2 embodiment 2 and comparative example 2-1
Measure the embodiment of the invention 2 and the prepared acetic acid abiraterone sheet of its comparative example; Be that medium (reference fluid), rotating speed are 50rpm with 900ml, 0.25%SDSpH4.5 phosphate buffer respectively; Respectively at 5,10,15,30,45,60 minutes sampling test sample dissolutions, the result saw table 2:
Table 2 control formulation, embodiment 2 and the comparative example dissolution % (n=6) in the pH4.5PBS medium:
The preparation of embodiment 3 acetic acid abiraterone sheets
Preparation technology: the acetic acid abiraterone that takes by weighing recipe quantity: lactose (1: 0.5), pulverize powder thing altogether, add surplus lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose (in add) and cross 80 mesh sieve mixings.Above-mentioned mixed powder is placed dry grinding cup, add 5% 30 POVIDONE K 30 BP/USP 90 aqueous solution system soft materials of the tween 80 that contains recipe quantity 0.1% in right amount, the granulation of 18 mesh sieves; Dry to moisture and be lower than 5%; 24 mesh sieve granulate add crosslinked carboxylic first 4 basic sodium cellulosates, magnesium stearate and silicon dioxide, mixing; Tabletting promptly gets.
Claims (11)
1. a solid composite is characterized in that containing acetic acid abiraterone, surfactant, binding agent, filler, disintegrating agent and lubricant, and wherein crude drug and hydrophilicity condiment are pulverized, and the control particle diameter is 0.1-50 μ m.
2. solid composite according to claim 1, the particle diameter that it is characterized in that crude drug are 10-30 μ m.
3. solid composite according to claim 1 is characterized in that hydrophilicity condiment is lactose, starch, maltose, mannitol, glucose or pregelatinized Starch, and further is preferably lactose.
4. solid composite according to claim 1 is characterized in that the ratio that raw material and hydrophilicity condiment are pulverized is 1: 0.1-1: 2 (w/w), and further be preferably 1: 0.5-1: 1 (w/w).
5. solid composite according to claim 1, the surfactant in it is characterized in that writing out a prescription is sodium lauryl sulphate or Tween 80, and further is preferably sodium lauryl sulphate.
6. solid composite according to claim 5, the addition that it is characterized in that sodium lauryl sulphate are the 0.01%-2% (w/w) of solid composite, and further are preferably 0.01-0.5% (w/w).
7. solid composite according to claim 5, the adding mode of sodium lauryl sulphate is in it is characterized in that writing out a prescription: the SDS of recipe quantity is added in the binder solution, granulate with other adjuvants.
8. solid composite according to claim 1 is characterized in that described binding agent is polyvinylpyrrolidone, hypromellose or hydroxypropyl cellulose, and further is preferably polyvinylpyrrolidone.
9. solid composite according to claim 8 is characterized in that the polyvinyl pyrrolidone model is K25, K30 or K90, and further is preferably K90.
10. solid composite according to claim 9, the concentration of the polyvinyl pyrrolidone that it is characterized in that adding is 5%-20% (w/w), and further is preferably 10%-15% (w/w); Consumption is preferably 0.5%-2% (w/w).
11. solid composite according to claim 1, said composition can be prepared into tablet, capsule, granule, and further preferred for preparation becomes tablet.
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| WO2014145813A1 (en) | 2013-03-15 | 2014-09-18 | Iceutica Inc. | Abiraterone acetate formulation |
| CN104069075A (en) * | 2013-03-26 | 2014-10-01 | 南京卡文迪许生物工程技术有限公司 | Abiraterone acetate tablet and preparing method thereof |
| WO2015032873A1 (en) * | 2013-09-06 | 2015-03-12 | Synthon B.V. | High-load pharmaceutical compositions comprising abiraterone acetate |
| CN104546745A (en) * | 2013-10-14 | 2015-04-29 | 深圳海王药业有限公司 | Tablet combination of abiraterone acetate and preparation method of tablet combination |
| WO2016001208A1 (en) | 2014-06-30 | 2016-01-07 | Galenicum Health S.L. | Stable pharmaceutical compositions in the form of immediate release tablets |
| CN105616364A (en) * | 2014-11-07 | 2016-06-01 | 深圳万乐药业有限公司 | Abiraterone acetate tablets and preparation method thereof |
| KR20170070025A (en) * | 2014-09-18 | 2017-06-21 | 아이슈티카 인코포레이티드 | Abiraterone acetate formulation and methods of use |
| US9889144B2 (en) | 2013-03-15 | 2018-02-13 | Iceutica Inc. | Abiraterone acetate formulation and methods of use |
| CN108514550A (en) * | 2018-04-10 | 2018-09-11 | 重庆华邦制药有限公司 | Solid drugs and preparation method thereof containing Abiraterone acetate |
| US10292990B2 (en) | 2013-09-27 | 2019-05-21 | Sun Pharma Global Fze | Abiraterone steroid formulation |
| WO2019206472A1 (en) | 2018-04-26 | 2019-10-31 | Synthon B.V. | Tablet compositions comprising abiraterone acetate |
| WO2020126017A1 (en) | 2018-12-20 | 2020-06-25 | Pharmaceutical Oriented Services Ltd | Dosage form containing abiraterone acetate |
| CN115515583A (en) * | 2020-05-08 | 2022-12-23 | 詹森药业有限公司 | Pharmaceutical formulations of abiraterone acetate and nilapanib acetate |
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- 2012-07-27 CN CN2012102621017A patent/CN102743393A/en active Pending
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| WO2016001208A1 (en) | 2014-06-30 | 2016-01-07 | Galenicum Health S.L. | Stable pharmaceutical compositions in the form of immediate release tablets |
| KR102491439B1 (en) | 2014-09-18 | 2023-01-25 | 썬 파마슈티칼 인더스트리스 리미티드 | Abiraterone acetate formulation and methods of use |
| KR20170070025A (en) * | 2014-09-18 | 2017-06-21 | 아이슈티카 인코포레이티드 | Abiraterone acetate formulation and methods of use |
| CN105616364A (en) * | 2014-11-07 | 2016-06-01 | 深圳万乐药业有限公司 | Abiraterone acetate tablets and preparation method thereof |
| CN105616364B (en) * | 2014-11-07 | 2018-11-02 | 深圳万乐药业有限公司 | Abiraterone acetate piece and preparation method thereof |
| CN108514550A (en) * | 2018-04-10 | 2018-09-11 | 重庆华邦制药有限公司 | Solid drugs and preparation method thereof containing Abiraterone acetate |
| WO2019206472A1 (en) | 2018-04-26 | 2019-10-31 | Synthon B.V. | Tablet compositions comprising abiraterone acetate |
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| WO2020126017A1 (en) | 2018-12-20 | 2020-06-25 | Pharmaceutical Oriented Services Ltd | Dosage form containing abiraterone acetate |
| CN115515583A (en) * | 2020-05-08 | 2022-12-23 | 詹森药业有限公司 | Pharmaceutical formulations of abiraterone acetate and nilapanib acetate |
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Application publication date: 20121024 |