CN111956615A - Finasteride solid preparation and preparation method thereof - Google Patents

Finasteride solid preparation and preparation method thereof Download PDF

Info

Publication number
CN111956615A
CN111956615A CN201910419604.2A CN201910419604A CN111956615A CN 111956615 A CN111956615 A CN 111956615A CN 201910419604 A CN201910419604 A CN 201910419604A CN 111956615 A CN111956615 A CN 111956615A
Authority
CN
China
Prior art keywords
finasteride
preparation
formulation according
solid formulation
lubricant
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.)
Pending
Application number
CN201910419604.2A
Other languages
Chinese (zh)
Inventor
付晓玉
胡运华
张娟
何葳轩
苏忠海
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chengdu Beite Pharmaceutical Co ltd
Original Assignee
Chengdu Beite Pharmaceutical Co ltd
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
Application filed by Chengdu Beite Pharmaceutical Co ltd filed Critical Chengdu Beite Pharmaceutical Co ltd
Priority to CN202310636502.2A priority Critical patent/CN116763750A/en
Priority to CN201910419604.2A priority patent/CN111956615A/en
Publication of CN111956615A publication Critical patent/CN111956615A/en
Pending legal-status Critical Current

Links

Images

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Urology & Nephrology (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a finasteride solid preparation and a preparation method thereof, and relates to the technical field of pharmaceutical preparations90Less than or equal to 20 mu m, and the auxiliary materials comprise one or more of povidone, poloxamer and copovidone. The invention can be directly prepared by dry method, no anionic surfactant and other components with pharmacological activity are introduced in the preparation process, and the obtained solid preparation has excellent disintegration and dissolution efficiency.

Description

Finasteride solid preparation and preparation method thereof
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to the technical field of finasteride preparations.
Background
Benign Prostatic Hyperplasia (BPH) is a common senile disease with increasing incidence as it ages. After BPH occurs to a patient, symptoms such as prostate enlargement and the like can occur, the prostate gradually presses the urethra, prevents urination and causes urinary tract obstruction, the urine is retained in the bladder, renal calculus and urinary tract infection are easy to further cause, and the kidney function of the patient can be further damaged due to long-term obstruction, so that serious consequences are generated.
Treatment of BPH is primarily with 5 α -reductase inhibitors, α -adrenergic receptor blockers, or a combination of both. Finasteride (finasteride) is a specific inhibitor of the intracellular enzyme type ii 5 α -reductase produced during the metabolism of the male hormone testosterone into dihydrotestosterone. It can inhibit prostatic hyperplasia by lowering dihydrotestosterone levels in blood and prostate tissue, and reduce prostate volume, increase maximal urine flow rate, and improve clinical symptoms associated with prostatic hyperplasia.
In addition to treating BPH, a small dose of finasteride can reduce the level of dihydrotestosterone in the scalp tissue of bald patients, thereby producing a therapeutic effect on male baldness.
Finasteride is white crystalline powder, is very soluble in chloroform and low-concentration alcoholic solution, but is not soluble in water, and the solubility of finasteride does not have solution pH dependence according to the solubility measurement result, so the problems of incomplete dissolution and low dissolution rate need to be solved when preparing a finasteride preparation or improving the curative effect of finasteride.
In view of the above problems, the prior art is generally solved by improving the preparation method of the process and adjusting the formula.
In the aspect of process preparation, in the prior art, wet granulation, melt granulation and other modes are selected to improve the dissolution rate and dissolution efficiency of a finasteride preparation, for example, an organic solvent ethanol and the like are introduced in the granulation process, active ingredient finasteride is dissolved in an ethanol-containing auxiliary material, and then wet granulation, re-drying, granule finishing, total mixing and tabletting are carried out, but the method generally has complex process and high control difficulty, and the introduced organic solvent also easily brings new technical problems; if the active ingredient finasteride is added into the melt liquid containing the organic reagent such as povidone and polyethylene glycol in the granulation process, then the active ingredient finasteride and other auxiliary materials are granulated, granulated and tabletted together, and the solubility of the drug is increased through melt granulation.
In the aspect of the formula, the finasteride tablet produced by merck company is added with an anionic surfactant docusate sodium as an excipient, the docusate sodium has pharmacological activity and can be used as a laxative and a stool softener in an oral preparation, and the change of gastrointestinal epithelial tissues can be caused after the oral preparation is taken, so that the absorption of other medicines in the gastrointestinal tract or the liver can be influenced, the possible toxicity of the medicines can be expanded, and unnecessary toxic and side effects can be brought to patients after long-term administration.
Disclosure of Invention
In view of the above technical problems, the present invention aims to provide a finasteride solid preparation which can be directly prepared by a dry method and has excellent disintegration and dissolution efficiency and crystal form stability.
The invention also aims to provide a finasteride solid preparation which can be directly prepared by a dry method, does not introduce an anionic surfactant and other components with pharmacological activity in the preparation process and has excellent disintegration and dissolution efficiency.
The invention also aims to provide a preparation method of the finasteride solid preparation, which can prepare the finasteride solid preparation.
The invention also aims to provide a preparation method of the finasteride solid preparation, wherein the crystal form transformation of the raw material medicine can not occur in the preparation process.
The invention firstly provides the following technical scheme:
a finasteride solid preparation contains active component finasteride and auxiliary materials, wherein the active component finasteride is micronized to the particle diameter D90Less than or equal to 20 mu m, preferably the particle size D90Less than or equal to 15 mu m; the adjuvants include polyvidone, poloxamer and copovidoneOne or more of (a).
In a preferred mode, the adjuvant is copovidone of povidone, poloxamer and copovidone, and is further preferably copovidone S630.
In the above technical solution or the preferred mode thereof, the content of the active ingredient is 1 to 10% by weight, preferably 3 to 7% by weight.
In a specific embodiment of the above technical solution or its preferred mode, the adjuvant further comprises a disintegrant.
Further: the adjuvants may also include fillers and lubricants.
Further: the auxiliary material also comprises a glidant, wherein the content of the glidant is 0.2-3% by weight, and preferably 0.2-1%.
In one embodiment of the invention, the adjuvant comprises one or more of microcrystalline cellulose, pregelatinized starch, lactose spray and cellulosic lactose.
In another embodiment of the present invention, the adjuvant comprises one or more of sodium carboxymethyl starch, croscarmellose sodium, and crospovidone.
In another embodiment of the present invention, the excipients include one or more of magnesium stearate, sodium stearyl fumarate, and talc.
In another embodiment of the present invention, the adjuvant comprises cellulose lactose, copovidone, sodium carboxymethyl starch and a synergistic lubricant, wherein the synergistic lubricant is selected from one or more of magnesium stearate, sodium stearyl fumarate and talc, and further, the adjuvant further comprises colloidal silicon dioxide.
In another embodiment of the invention, the mass ratio of the active ingredient finasteride to the cellulose lactose, the copovidone, the sodium carboxymethyl starch and the synergistic lubricant in the solid preparation is 1: 25-26: 1-2: 0.2-0.3, and further, when the auxiliary material comprises colloidal silicon dioxide, the mass ratio of the active ingredient finasteride to the colloidal silicon dioxide is 1: 0.15-0.02.
The invention also provides a preparation method of the finasteride solid preparation, which comprises the following steps:
(1) micronizing the active component finasteride to obtain a particle size D90Less than or equal to 20 mu m, preferably the particle size D90≤15μm；；
(2) Mixing micronized finasteride with adjuvants, sieving, mixing, and tabletting; if the auxiliary materials contain the lubricant, the micronized finasteride and the auxiliary materials except the lubricant are mixed, sieved and mixed, and finally the lubricant is added for total mixed tabletting;
the preparation method can also comprise the step (3) of coating the tabletted plain tablets.
Wherein:
the auxiliary material at least comprises one or more of povidone, poloxamer and copovidone.
The adjuvant may also include a disintegrant.
The adjuvants may also include fillers and lubricants.
The adjuvant may also include a glidant.
When the auxiliary material comprises one or more of povidone, poloxamer and copovidone, the weight percentage content of the povidone and/or poloxamer and/or copovidone is 1-10%, and preferably 3-7%.
When the auxiliary material comprises a flow aid, the content of the flow aid is 0.2-3% by weight, and preferably 0.2-1% by weight.
The finasteride solid preparation can directly mix and tablet raw materials, realizes dry preparation, does not need to introduce a solvent in the manufacturing process, does not need to add other components with pharmacological activity such as an anionic surfactant and the like, does not need to carry out high-temperature treatment such as melting and the like, does not need additional drying steps, has simple process, low production cost and high production controllability, has good crystal form consistency of the active component finasteride in the whole preparation process, and has extremely high dissolution efficiency and medicament stability.
Drawings
FIG. 1 is an XRD spectrum of different samples in example six of the present invention.
Detailed Description
The present invention is described in further detail below with reference to some specific embodiments and examples, but it should not be construed that the scope of the present invention is limited to the examples below. Various substitutions and alterations can be made by those skilled in the art and by conventional means without departing from the spirit of the method of the invention described above.
The finasteride solid preparation contains active component finasteride and auxiliary material, wherein the active component finasteride is micronized to the particle diameter D90Less than or equal to 20 mu m, preferably the particle size D90Less than or equal to 15 mu m; the adjuvant comprises one or more of polyvidone, poloxamer and copovidone.
Wherein the active ingredient finasteride refers to finasteride crystals meeting the medical requirements.
In a preferred embodiment, the excipient is copovidone, or copovidone and other types of excipients.
The above "other types" refer to other pharmaceutical excipients except povidone, poloxamer and copovidone and substances similar to the functions thereof.
As in one embodiment, other types of excipients include disintegrants.
Or/and other types of excipients including fillers and/or lubricants and/or glidants.
When copovidone is contained in the solid formulation, copovidone S630 is preferably used.
When the solid preparation contains povidone and/or poloxamer and/or copovidone, the content of the povidone and/or poloxamer and/or copovidone is preferably 1-10 wt%, and more preferably 3-7 wt%.
When the solid preparation contains a glidant, the content of the glidant is preferably 0.2-3 wt%, and more preferably 0.2-1 wt%.
In the above embodiment:
the filler is an agent for filling the weight or volume of the solid preparation so as to facilitate tabletting or granulation, such as starches, sugars, celluloses, inorganic salts, and complexes, and specifically, such as corn starch, sugar powder, dextrin, lactose, pregelatinized starch, microcrystalline cellulose, inorganic salts, mannitol, lactose spray, and cellulose lactose.
The disintegrating agent is a reagent capable of rapidly disintegrating solid preparation into fine granules in gastrointestinal fluid, such as starch, cellulose, salt and compound, such as dry starch, sodium carboxymethyl starch, low-substituted cellulose, cross-linked PVP, cross-linked CCNa, effervescent disintegrating agent, etc.
The lubricant is an agent capable of improving the friction force between particles of the solid preparation so as to improve the flowability of the powder of the preparation, such as inorganic salts, organic dispersing agents and the like, and specifically, such as talcum powder, PEG, magnesium stearate, sodium stearyl fumarate and the like.
The glidant is a reagent capable of reducing the viscosity impact in the preparation process and reducing the friction between granules and between tablets and the wall of a die hole to ensure that the surface of the preparation is smooth and attractive, and specifically comprises talcum powder, colloidal silicon dioxide and the like.
The finasteride solid preparation contains active component finasteride and auxiliary material, wherein the active component finasteride is micronized to the particle diameter D90Less than or equal to 20 mu m, preferably the particle size D90Less than or equal to 15 mu m; the auxiliary materials comprise one or more of povidone, poloxamer and copovidone, and also comprise one or more of microcrystalline cellulose, pregelatinized starch, lactose spray and cellulose lactose.
In a further specific embodiment thereof, the adjuvant further comprises one or more of sodium carboxymethyl starch, croscarmellose sodium, and crospovidone.
Or/and, in a further specific embodiment thereof, the auxiliary material further comprises one or more of magnesium stearate, sodium stearyl fumarate and talc.
Or/and, in a further specific embodiment thereof, the auxiliary material comprises cellulose lactose, copovidone, sodium carboxymethyl starch and a synergistic lubricant, wherein the synergistic lubricant is selected from one or more of magnesium stearate, sodium stearyl fumarate and talcum powder, and further, the auxiliary material also comprises colloidal silicon dioxide.
In a further specific embodiment, the mass ratio of the active ingredient finasteride to the cellulose lactose, the copovidone, the sodium carboxymethyl starch and the synergistic lubricant in the solid preparation is 1: 25-26: 1-2: 0.2-0.3.
In a further specific embodiment, the mass ratio of the active ingredients finasteride to the cellulose lactose, the copovidone, the sodium carboxymethyl starch, the synergistic lubricant and the colloidal silicon dioxide in the solid preparation is 1: 25-26: 1-2: 0.2-0.3: 0.15 to 0.02. The preparation method comprises the following steps:
(1) micronizing the active component finasteride to obtain a particle size D90Less than or equal to 20 mu m, preferably the particle size D90≤15μm；；
(2) Mixing micronized finasteride with adjuvants, sieving, mixing, and tabletting; if the auxiliary materials contain the lubricant, the micronized finasteride and the auxiliary materials except the lubricant are mixed, sieved and mixed, and finally the lubricant is added into the total mixed tablets after uniform mixing;
the preparation method can also comprise the step (3) of coating the tabletted plain tablets.
The micronization treatment can be performed by using conventional micronization equipment as long as the particle size requirement of the invention can be realized.
In the above preparation steps, the lubricant refers to the synergistic lubricant when a specific synergistic lubricant is selected.
Example 1
Tabletting through the steps (1) - (2) of the preparation method provided in the above embodiment to obtain a finasteride solid tablet, wherein the micronized finasteride D905.6 μm, the final compression was achieved by a 7mm diameter shallow arc punch, using the following formulation:
Figure 455074DEST_PATH_IMAGE002
example 2
Tabletting through the steps (1) - (2) of the preparation method provided in the above embodiment, wherein the micronized finasteride D is subjected to tabletting90At 10 μm, the final compression was achieved by a 7mm diameter shallow arc punch, using the following formulation:
Figure 309898DEST_PATH_IMAGE004
；
the stability of the prepared finasteride solid preparation is inspected, and the following inspection results are obtained:
Figure 89635DEST_PATH_IMAGE006
from the examination results, it can be seen that the finasteride solid preparation prepared according to this example has high stability under a high temperature environment for a long time.
Example 3
Tabletting through the steps (1) - (2) of the preparation method provided in the above embodiment, wherein the micronized finasteride D is subjected to tabletting90At 15 μm, the final compression was achieved by a 7mm diameter shallow arc punch, using the following formulation:
Figure 484844DEST_PATH_IMAGE008
example 4 comparative example
Tabletting through the steps (1) - (2) of the preparation method provided in the above embodiment, wherein the micronized finasteride D is subjected to tabletting9022.5 μm, the final tablet was obtained by a 7mm diameter shallow arc punch, using the following formulation setThe composition is as follows:
Figure DEST_PATH_IMAGE009
example 5 comparative example
Tabletting through the steps (1) - (2) of the preparation method provided in the above embodiment, wherein the micronized finasteride D is subjected to tabletting905.6 μm, the final compression was achieved by a 7mm diameter shallow arc punch, using the following formulation:
Figure DEST_PATH_IMAGE011
the dissolution rate of the finasteride solid tablets obtained in the above examples 1 to 5 is tested by a paddle method, and the parameters and reagents selected are as follows: the rotation speed is 50rpm, the medium is 0.1mol/L hydrochloric acid solution, the medium volume is 900mL, the sampling time points are 5, 10, 15 and 60min, the determination method is high performance liquid chromatography, and the dissolution rate determination results (%) of each example are shown in the following table:
sample source 5min 10min 15min 60min
Example 1 57.3 91.1 93.9 98.5
Example 2 77.3 90.4 95.5 97.4
Example 3 82.5 92.1 94.0 97
Example 4 24.9 41.6 52.6 73.2
Example 5 76.0 79.6 80.8 86.6
From the above results, it can be seen that the finasteride solid tablets prepared in examples 1 to 3 were eluted faster than the finasteride solid tablets prepared in examples 4 to 5, and reached 85% or more in 15 min.
EXAMPLE six
The following comparative samples were prepared:
BTYY-INT013 sample 1: a blank auxiliary material sample;
BTYY-INT013 sample 7: reference formulation (finasteride tablet from merck);
BTYY-INT013 sample 8: a finasteride solid formulation prepared from example 2;
BTYY-INT013 sample 9: finasteride bulk drug;
BTYY-INT013 sample 10: the ingredients in the formulation of example 2 were mixed without tableting to obtain a total blended powder;
BTYY-INT013 sample 11: the prescription proportion of the raw material medicines is improved, and the following formula is adopted for preparing the preparation:
finasteride bulk drug 50mg
Cellulose-lactose 88.37mg
Co-polyvidone 5.17mg
Sodium carboxymethyl starch 5.17mg
Magnesium stearate 0.78mg
Colloidal silica 0.52 mg
Tabletting through the steps (1) - (2) of the preparation method provided in the specific embodiment, wherein the micronized finasteride bulk drug D is subjected to tabletting90Is 10 μm.
XRD (X-ray diffraction) tests are carried out on the samples to obtain a spectrogram shown in an attached drawing 1, the fact that the finasteride solid reagent disclosed by the invention is consistent in crystal form before, after and during preparation can be seen from the spectrogram, the crystal form of the solid preparation obtained by the preparation process disclosed by the invention is consistent with that of the raw material medicine, and the fact that the finasteride solid preparation with stable crystal form can be obtained by the preparation method and the formula disclosed by the invention is proved.

Claims (10)

1. A finasteride solid preparation is characterized in that: the solid preparation contains active ingredient finasteride and auxiliary materials, wherein the active ingredient finasteride is micronized to the particle diameter D90Less than or equal to 20 mu m, preferably the particle size D90Less than or equal to 15 mu m; the auxiliary material comprises one or more of povidone, poloxamer and copovidone, preferably copovidone.
2. A finasteride solid formulation according to claim 1, wherein: the weight percentage content of the active ingredients is 1-10%, and preferably 3-7%.
3. A finasteride solid formulation according to claim 2, wherein: the auxiliary material also comprises a disintegrating agent.
4. A finasteride solid formulation according to claim 3, wherein: the auxiliary materials also comprise a filling agent and a lubricating agent.
5. A finasteride solid formulation according to claim 4, wherein: the auxiliary material also comprises a glidant, wherein the content of the glidant is 0.2-3% by weight, and preferably 0.2-1%.
6. A finasteride solid formulation according to claim 1, wherein: the auxiliary materials also comprise one or more of microcrystalline cellulose, pregelatinized starch, lactose spray and cellulose lactose; the auxiliary materials also comprise one or more of magnesium stearate, sodium stearyl fumarate and talcum powder.
7. A finasteride solid formulation according to claim 1, wherein: the auxiliary materials also comprise one or more of sodium carboxymethyl starch, croscarmellose sodium and crospovidone.
8. A finasteride solid formulation according to claim 1, wherein: the auxiliary material also comprises cellulose lactose, copovidone, sodium carboxymethyl starch and a synergistic lubricant, wherein the synergistic lubricant is selected from one or more of magnesium stearate, sodium stearyl fumarate and talcum powder, and further, the auxiliary material also comprises colloidal silicon dioxide.
9. A finasteride solid formulation according to claim 8, wherein: the solid preparation comprises the active ingredients of finasteride, cellulose lactose, copovidone, sodium carboxymethyl starch and a synergistic lubricant in a mass ratio of 1: 25-26: 1-2: 0.2-0.3, and further comprises the active ingredients of finasteride and colloidal silicon dioxide in a mass ratio of 1: 0.15-0.02 when the auxiliary material comprises colloidal silicon dioxide.
10. The method for preparing finasteride solid formulation according to any one of claims 1 to 9, wherein: the method comprises the following steps:
(1) micronizing the active component finasteride to obtain a particle size D90Less than or equal to 20 mu m, preferably the particle size D90≤15μm；；
(2) Mixing micronized finasteride with adjuvants, sieving, mixing, and tabletting; if the auxiliary materials contain the lubricant, the micronized finasteride and the auxiliary materials except the lubricant are mixed, sieved and mixed, and finally the lubricant is added for total mixed tabletting;
the preparation method can also comprise the step (3) of coating the tabletted plain tablets.
CN201910419604.2A 2019-05-20 2019-05-20 Finasteride solid preparation and preparation method thereof Pending CN111956615A (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN202310636502.2A CN116763750A (en) 2019-05-20 2019-05-20 Finasteride solid preparation with high dissolution rate
CN201910419604.2A CN111956615A (en) 2019-05-20 2019-05-20 Finasteride solid preparation and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201910419604.2A CN111956615A (en) 2019-05-20 2019-05-20 Finasteride solid preparation and preparation method thereof

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN202310636502.2A Division CN116763750A (en) 2019-05-20 2019-05-20 Finasteride solid preparation with high dissolution rate

Publications (1)

Publication Number Publication Date
CN111956615A true CN111956615A (en) 2020-11-20

Family

ID=73357755

Family Applications (2)

Application Number Title Priority Date Filing Date
CN201910419604.2A Pending CN111956615A (en) 2019-05-20 2019-05-20 Finasteride solid preparation and preparation method thereof
CN202310636502.2A Pending CN116763750A (en) 2019-05-20 2019-05-20 Finasteride solid preparation with high dissolution rate

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN202310636502.2A Pending CN116763750A (en) 2019-05-20 2019-05-20 Finasteride solid preparation with high dissolution rate

Country Status (1)

Country Link
CN (2) CN111956615A (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20230028609A (en) * 2021-08-19 2023-03-02 한국프라임제약주식회사 Scored divisible pharmaceutical tablets comprising finasteride

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103860495A (en) * 2014-03-07 2014-06-18 广东罗特制药有限公司 Finasteride dispersible tablet and preparation method thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103860495A (en) * 2014-03-07 2014-06-18 广东罗特制药有限公司 Finasteride dispersible tablet and preparation method thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
姜文雅等: "共聚维酮在药物制剂中应用的研究进展", 《中国医药工业杂志》 *
杨明等: "《药剂学 第2版》", 31 August 2018, 中国医药科技出版社 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20230028609A (en) * 2021-08-19 2023-03-02 한국프라임제약주식회사 Scored divisible pharmaceutical tablets comprising finasteride
KR102682487B1 (en) * 2021-08-19 2024-07-08 한국프라임제약주식회사 Scored divisible pharmaceutical tablets comprising finasteride

Also Published As

Publication number Publication date
CN116763750A (en) 2023-09-19

Similar Documents

Publication Publication Date Title
EP1849459A1 (en) Ezetimibe compositions
PL200957B1 (en) Celecoxib compositions and the use thereof
TWI415633B (en) Solid preparations containing enteric solid dispersions
WO2012043709A1 (en) Preparation for improving solubility of poorly soluble drug
JP2004500358A (en) Celecoxib in the solid state with increased bioavailability
WO2008134557A2 (en) Solid dosage forms
US20230190732A1 (en) Pharmaceutical composition containing nitroxoline prodrug, and preparation method and application therefor
JP2009079034A (en) New niacin controlled-release-type preparation
KR101050076B1 (en) Compositions of Oral Formulations Containing Controlled Release Aceclofenac and Methods for Making the Same
AU745697B2 (en) Lipstatin derivative-soluble fiber tablets
KR101381999B1 (en) Gastroretentive system containing solubilized drug for maximizing its therapeutic effect for gastritis
CN111956615A (en) Finasteride solid preparation and preparation method thereof
EP3697392B1 (en) Tablets comprising tamsulosin and solifenacin
US20050118256A1 (en) Extended release alpha-2 agonist pharmaceutical dosage forms
US20100003319A1 (en) Raloxifene immediate release tablets
US20060182803A1 (en) Oral sustained-release pharmaceutical composition of indapamide, production and use thereof
KR101076648B1 (en) Controlled-release Aceclofenac Containing Oral Drug Preparations and it's Manufacturing Process
JP6328138B2 (en) Of N- [5- [2- (3,5-dimethoxyphenyl) ethyl] -2H-pyrazol-3-yl] -4-[(3R, 5S) -3,5-dimethylpiperazin-1-yl] benzamide Pharmaceutical formulation
CN108096251B (en) Gefitinib pharmaceutical composition and preparation method thereof
JP2021518422A (en) Pharmaceutical composition containing lenalidomide
US20080138412A1 (en) Sustained release alfuzosin hydrochl formulation and method for their production
KR20190070053A (en) Pharmaceutical Formulations of Dapagliflozin Free Base and Method for Preparing thereof
US20090264495A1 (en) Oral sustained-release pharmaceutical composition of indapamide, production and use thereof
KR20220097364A (en) Pharmaceutical composition comprising tadalafil or pharmaceutical salts thereof and dutasteride or pharmaceutical salts thereof with novel dissolution rate
TW202435886A (en) Milvexian pharmaceutical compositions

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
RJ01 Rejection of invention patent application after publication
RJ01 Rejection of invention patent application after publication

Application publication date: 20201120