CN107137374B - Solid pharmaceutical composition of palonosetron - Google Patents

Solid pharmaceutical composition of palonosetron Download PDF

Info

Publication number
CN107137374B
CN107137374B CN201710478333.9A CN201710478333A CN107137374B CN 107137374 B CN107137374 B CN 107137374B CN 201710478333 A CN201710478333 A CN 201710478333A CN 107137374 B CN107137374 B CN 107137374B
Authority
CN
China
Prior art keywords
palonosetron
pharmaceutical composition
pharmaceutically acceptable
solid pharmaceutical
acceptable salt
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.)
Active
Application number
CN201710478333.9A
Other languages
Chinese (zh)
Other versions
CN107137374A (en
Inventor
晏彩霞
张来芳
吴秀兰
吴蓓静
隋姗姗
万顺之
周浩
陈智林
戴峻
徐中南
张喜全
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.)
Chia Tai Tianqing Pharmaceutical Group Co Ltd
Original Assignee
Chia Tai Tianqing Pharmaceutical Group 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 Chia Tai Tianqing Pharmaceutical Group Co Ltd filed Critical Chia Tai Tianqing Pharmaceutical Group Co Ltd
Priority to CN201710478333.9A priority Critical patent/CN107137374B/en
Publication of CN107137374A publication Critical patent/CN107137374A/en
Application granted granted Critical
Publication of CN107137374B publication Critical patent/CN107137374B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention relates to a solid pharmaceutical composition of palonosetron, which comprises palonosetron or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable excipient, wherein the solid pharmaceutical composition does not contain a binding agent.

Description

Solid pharmaceutical composition of palonosetron
The application is a divisional application with application number 201210186522.6, application date 2012, 6/2, entitled "solid pharmaceutical composition of palonosetron".
Technical Field
The invention relates to a pharmaceutical composition, in particular to a composition containing 5-HT for treating nausea and vomiting caused by cancer chemotherapy drugs3An oral pharmaceutical composition of a receptor antagonist, a preparation method thereof and application thereof in the field of medicine.
Background
Palonosetron has a structural formula shown aS a formula I, and has a chemical name of (3aS) -2- [ (3s) -1-azabicyclo [2.2.2]Octyl-2, 3,3a,4,5, 6-hexahydro-1-oxo-1H-benzo [ de ]]Isoquinoline, Selective 5-HT developed by Helsinn3A receptor antagonist. Palonosetron hydrochloride injection was approved by the United states Food and Drug Administration (FDA) in 2003 for the treatment of moderate or high grade disordersAcute and delayed nausea and vomiting caused by emetic chemotherapy.
Figure BDA0001328618400000011
The drugs for treating nausea and vomiting need to have fast onset and high bioavailability when being taken, so the palonosetron is usually prepared into injections in the prior art, but the injections have the problems of stability and the like, and the prior art discloses that the stability of the injections is improved by adjusting the pH range to be 4.0-6.0 and adding mannitol and a chelating agent (CN 1758911).
In order to further improve the stability of palonosetron injections, the prior art also discloses soft capsule formulations, for example CN101573106 discloses a soft capsule formulation of palonosetron, which has a permeability of less than about 1.0X 10 by using oxygen-3ml·cm/(cm224hr.atm), and optionally an antioxidant to obtain a highly stable oral formulation of palonosetron.
WO2010077669 discloses a stable solid formulation of palonosetron. In a preferred form the solid formulation is a hard gelatin capsule comprising palonosetron or a salt thereof, a diluent, a binder, a disintegrant, a lubricant, and preferably the formulation does not contain an antioxidant. The invention solves the problems of certain dispersion uniformity, drug dissolution and bioavailability, but the prescription is complex, and in order to further meet the requirements of fast effect and high bioavailability of palonosetron, a stable palonosetron solid preparation with higher dissolution speed and high bioavailability needs to be developed.
Disclosure of Invention
The invention provides a solid pharmaceutical composition of palonosetron, which comprises palonosetron or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable excipient, wherein the solid pharmaceutical composition does not contain a binding agent.
The invention also provides a solid pharmaceutical composition of palonosetron, which consists of palonosetron or a pharmaceutically acceptable salt thereof, a diluent, a disintegrant and a lubricant.
Pharmaceutically acceptable salts of palonosetron include salts of inorganic acids such as hydrochloride, hydrobromide, sulfate, nitrate, phosphate and the like, salts of organic acids such as acetate, propionate, butyrate, valerate, hexanoate, heptanoate, cypionate, cyclohexanoate, oxalate, pyruvate, lactate, malonate, succinate, malate, maleate, fumarate, tartrate, citrate, benzoate, cinnamate, phenylacetate, methanesulfonate, ethanesulfonate, laurylsulfonate, gluconate, glutamate, salicylate, stearate, hexadienedioate and the like. Among them, palonosetron hydrochloride is preferable.
The diluent is selected from one or a mixture of more of lactose, microcrystalline cellulose, starch, pregelatinized starch, sucrose, glucose, mannitol, sorbitol, xylitol, dextrin, calcium sulfate, calcium hydrogen phosphate, dicalcium phosphate, calcium phosphate monohydrate, cellulose, ethyl cellulose, kaolin, calcium carbonate, magnesium carbonate and light magnesium oxide, and preferably one or a mixture of two of lactose and microcrystalline cellulose.
The weight ratio of the diluent to the palonosetron or the pharmaceutically acceptable salt thereof (calculated by the palonosetron) is 50-1000: 1, preferably 100-500: 1, and more preferably 100-400: 1.
The disintegrant is selected from any one or a mixture of more of sodium carboxymethyl cellulose, calcium carboxymethyl cellulose, croscarmellose sodium, crospovidone, starch, sodium carboxymethyl starch, hydroxypropyl starch, low-substituted hydroxypropyl cellulose, magnesium aluminum silicate, sodium bicarbonate, sodium starch glycolate, alginic acid, sodium alginate, tartaric acid, citric acid, sodium bicarbonate, sodium carbonate, polysorbate 80 and sodium lauryl sulfate, preferably sodium carboxymethyl starch and crospovidone, and more preferably sodium carboxymethyl starch.
The weight ratio of the disintegrating agent to palonosetron or a pharmaceutically acceptable salt thereof (calculated by palonosetron) is 5-30: 1, preferably 5-20: 1, and more preferably 10-15: 1.
The lubricant is one or a mixture of more of stearic acid, calcium stearate, magnesium stearate, talcum powder, superfine silica powder, polyethylene glycol, glyceryl monostearate, magnesium lauryl sulfate, sodium lauryl sulfate and sodium benzoate, and preferably magnesium stearate.
The weight ratio of the lubricant to the palonosetron or the pharmaceutically acceptable salt thereof (calculated by the palonosetron) is 0.1-10: 1, preferably 0.5-5: 1, and more preferably 1-2: 1.
The solid pharmaceutical composition of the present invention can be capsules, tablets, granules, preferably hard capsule preparations.
As another preferred mode, the solid pharmaceutical composition of the present invention is a hard capsule formulation consisting of palonosetron or a pharmaceutically acceptable salt thereof, lactose, microcrystalline cellulose, sodium carboxymethyl starch and magnesium stearate.
The solid pharmaceutical composition of the present invention may be contained in a dosage form of 0.25mg, 0.5mg, or 0.75mg, i.e., 0.25mg, 0.5mg, or 0.75mg of palonosetron per unit dosage form.
Meanwhile, the invention also provides a preparation method of the solid pharmaceutical composition of palonosetron, which comprises the steps of uniformly mixing the palonosetron or the medicinal salt thereof and pharmaceutically acceptable excipients, and then preparing granules, tablets or capsules by using a known preparation method, wherein the pharmaceutically acceptable excipients do not contain a binding agent.
The invention also provides a preparation method of the solid pharmaceutical composition of palonosetron, which comprises the steps of uniformly mixing palonosetron or the pharmaceutical salt thereof, a diluent, a disintegrating agent and a lubricating agent, and then preparing granules, tablets or capsules by using a known preparation method.
The invention also provides a preparation method of the solid pharmaceutical composition of palonosetron, which comprises the steps of uniformly mixing palonosetron or a pharmaceutically acceptable salt thereof with lactose, microcrystalline cellulose, sodium carboxymethyl starch and magnesium stearate to serve as an intermediate, taking a proper amount of an intermediate sample, detecting moisture and drug content, filling a hard capsule according to the drug content of the intermediate, inspecting and packaging.
The mixing in the above preparation method can be direct mixing, wet granulation mixing, dry granulation mixing, equivalent progressive mixing and other mixing methods known by those skilled in the art, or can be mixing the raw material medicines and/or excipients after pulverizing.
In addition, the invention also provides application of the palonosetron solid pharmaceutical composition in preparing a medicament for preventing and treating emesis.
The solid pharmaceutical composition of the lonosetron provided by the invention has the advantages of simple prescription process, good stability, no over-high requirements on oxygen content and oxygen permeability, and is suitable for industrial mass production. The palonosetron solid pharmaceutical composition has high bioavailability equivalent to that of a liquid preparation such as an injection, has higher dissolution speed, takes effect faster when being taken by a patient, and can exert curative effect faster and better.
Detailed Description
The invention is further illustrated by the following examples, but is not limited to these examples.
EXAMPLE 1 preparation of hard capsules of Palonosetron
Figure BDA0001328618400000051
Taking palonosetron hydrochloride with the prescription amount, adding 5 times of lactose, mixing, performing jet milling, adding 5 times of lactose into the obtained mixed powder, uniformly mixing, adding the rest lactose, microcrystalline cellulose and carboxymethyl starch sodium with the prescription amount, uniformly mixing, and finally adding magnesium stearate, and uniformly mixing. The obtained powder was sampled at 10 different positions, and an appropriate amount of powder (equivalent to 0.5mg of palonosetron) was weighed at each sampling point, and the moisture content was measured and the percentage content of each point was determined. And (5) filling, inspecting and packaging the capsules according to the detection result of the content of the intermediate to obtain the capsule.
EXAMPLE 2 preparation of hard capsules of Palonosetron
Figure BDA0001328618400000052
Taking palonosetron hydrochloride with the prescription amount, adding 5 times of lactose, mixing, performing jet milling, adding 5 times of lactose into the obtained mixed powder, uniformly mixing, adding the rest lactose, microcrystalline cellulose and carboxymethyl starch sodium with the prescription amount, uniformly mixing, and finally adding magnesium stearate, and uniformly mixing. The obtained powder was sampled at 10 different positions, and an appropriate amount of powder (equivalent to 0.25mg of palonosetron) was weighed at each sampling point, and the moisture content was measured and the percentage content of each point was determined. And (5) filling, inspecting and packaging the capsules according to the detection result of the content of the intermediate to obtain the capsule.
EXAMPLE 3 preparation of hard capsules of Palonosetron
Figure BDA0001328618400000061
Taking palonosetron hydrochloride with the prescription amount, adding 5 times of lactose, mixing, performing jet milling, adding 5 times of lactose into the obtained mixed powder, uniformly mixing, adding the rest lactose, microcrystalline cellulose and carboxymethyl starch sodium with the prescription amount, uniformly mixing, and finally adding magnesium stearate, and uniformly mixing. The obtained powder was sampled at 10 different positions, and an appropriate amount of powder (equivalent to 0.75mg of palonosetron) was weighed at each sampling point, and the moisture content was measured and the percentage content of each point was determined. And (5) filling, inspecting and packaging the capsules according to the detection result of the content of the intermediate to obtain the capsule.
EXAMPLE 4 preparation of hard capsules of Palonosetron
Figure BDA0001328618400000062
Taking palonosetron hydrochloride with the prescription amount, adding 5 times of lactose, mixing, performing jet milling, adding 5 times of lactose into the obtained mixed powder, uniformly mixing, adding the rest lactose, microcrystalline cellulose and carboxymethyl starch sodium with the prescription amount, uniformly mixing, and finally adding magnesium stearate, and uniformly mixing. The obtained powder was sampled at 10 different positions, and an appropriate amount of powder (equivalent to 0.5mg of palonosetron) was weighed at each sampling point, and the moisture content was measured and the percentage content of each point was determined. And (5) filling, inspecting and packaging the capsules according to the detection result of the content of the intermediate to obtain the capsule.
EXAMPLE 5 preparation of hard capsules of Palonosetron
Figure BDA0001328618400000071
Taking palonosetron hydrochloride with the prescription amount, adding 5 times of lactose, mixing, performing jet milling, adding 5 times of lactose into the obtained mixed powder, uniformly mixing, adding the rest lactose, microcrystalline cellulose and carboxymethyl starch sodium with the prescription amount, uniformly mixing, and finally adding magnesium stearate, and uniformly mixing. The obtained powder was sampled at 10 different positions, and an appropriate amount of powder (equivalent to 0.5mg of palonosetron) was weighed at each sampling point, and the moisture content was measured and the percentage content of each point was determined. And (5) filling, inspecting and packaging the capsules according to the detection result of the content of the intermediate to obtain the capsule.
EXAMPLE 6 preparation of hard capsules of Palonosetron
Figure BDA0001328618400000072
Taking palonosetron hydrochloride with the prescription amount, adding 5 times of lactose, mixing, performing jet milling, adding 5 times of lactose into the obtained mixed powder, uniformly mixing, and then adding the rest lactose and the croscarmellose sodium with the prescription amount, and uniformly mixing. The obtained powder was sampled at 10 different positions, and an appropriate amount of powder (equivalent to 0.75mg of palonosetron) was weighed at each sampling point, and the moisture content was measured and the percentage content of each point was determined. And (5) filling, inspecting and packaging the capsules according to the detection result of the content of the intermediate to obtain the capsule.
EXAMPLE 7 preparation of hard capsules of Palonosetron
Figure BDA0001328618400000073
Figure BDA0001328618400000081
Taking the prescription dose of palonosetron hydrochloride, mannitol, sucrose, sodium starch glycolate and superfine silica gel powder, and uniformly mixing. The obtained powder was sampled at 10 different positions, and an appropriate amount of powder (equivalent to 0.5mg of palonosetron) was weighed at each sampling point, and the moisture content was measured and the percentage content of each point was determined. And (5) filling, inspecting and packaging the capsules according to the detection result of the content of the intermediate to obtain the capsule.
EXAMPLE 8 preparation of hard capsules of Palonosetron
Figure BDA0001328618400000082
Taking the palonosetron hydrochloride, the glucose, the dextrin, the crospovidone and the calcium stearate in the prescription amount, and uniformly mixing. The obtained powder was sampled at 10 different positions, and an appropriate amount of powder (equivalent to 0.5mg of palonosetron) was weighed at each sampling point, and the moisture content was measured and the percentage content of each point was determined. And (5) filling, inspecting and packaging the capsules according to the detection result of the content of the intermediate to obtain the capsule.
Example 9 accelerated stability testing of Palonosetron hard capsules
According to the guiding principle of the stability test of bulk drugs and pharmaceutical preparations (XI X C in the appendix XI of the second part of the Chinese pharmacopoeia 2005 edition), the stability of the palonosetron hydrochloride capsule under the accelerated test (40 ℃ C. + -. 2 ℃ C., RH 75% + -. 5%) is examined.
Three batches of samples prepared in example 1 were placed in a commercially available packaging form (aluminum plastic packaging) in a constant temperature and humidity chamber at a temperature of 40 ℃. + -. 2 ℃ and a relative humidity of 75%. + -. 5% under dark conditions for accelerated testing, and sampled and tested at months 1, 2,3 and 6, respectively, and the test results were compared with the initial results at month 0, and the results are shown in Table 1.
Table 1:
Figure BDA0001328618400000091
example 10 Palonosetron hard Capsule bioavailability test
The bioavailability of the palonosetron hard capsules was tested according to the guidelines for testing human bioavailability and bioequivalence of pharmaceutical preparations (appendix XIX B of the second part of the Chinese pharmacopoeia, edition 2005).
The hard palonosetron hydrochloride capsules (0.5mg) prepared in example 1 were orally administered to 12 healthy subjects, men and women, and the absolute bioavailability of the orally administered palonosetron hydrochloride capsules was determined as compared to a single intravenous injection of 0.5mg palonosetron hydrochloride injection.
And (3) test results: the absolute bioavailability (F109.9 +/-26.1%) of the oral palonosetron hydrochloride capsule is equivalent to that of intravenous injection.
Example 11 dissolution test comparison
Taking the palonosetron hydrochloride hard capsule prepared in example 1, referring to dissolution test conditions in patent application WO2010/077669, taking 500ml of 0.01M hydrochloric acid solution as a dissolution medium, operating according to the method at a rotation speed of 75 revolutions per minute, taking a proper amount of dissolution liquid (the sampling volume of the dissolution liquid at each time point is 3ml, and timely supplementing dissolution media with the same volume and the same temperature in a dissolution cup) at 15, 30, 45 and 60 minutes, filtering, and taking a subsequent filtrate as a test solution; and accurately weighing a proper amount of palonosetron hydrochloride reference substance, dissolving and diluting the palonosetron hydrochloride reference substance by using a 0.01M hydrochloric acid solution to prepare a solution containing about 1ug of palonosetron per 1ml, and shaking up to obtain the reference substance solution. And calculating the cumulative dissolution amount of the medicine of each capsule at each time point according to an external standard method. The results of the measurements are shown in Table 2 below.
Table 2:
Figure BDA0001328618400000101

Claims (3)

1. a solid pharmaceutical composition of palonosetron is composed of palonosetron or a pharmaceutically acceptable salt thereof, a diluent, a disintegrating agent and a lubricant, wherein the palonosetron is palonosetron hydrochloride, the diluent is a mixture of lactose and microcrystalline cellulose, the weight ratio of the diluent to the palonosetron or the pharmaceutically acceptable salt thereof (calculated as palonosetron) is 190:1, the disintegrating agent is sodium carboxymethyl starch, the weight ratio of the disintegrating agent to the palonosetron or the pharmaceutically acceptable salt thereof (calculated as palonosetron) is 10:1, the lubricant is magnesium stearate, the weight ratio of the lubricant to the palonosetron or the pharmaceutically acceptable salt thereof (calculated as palonosetron) is 1:1, and the solid pharmaceutical composition is a hard capsule.
2. A process for preparing a pharmaceutical composition according to claim 1, which comprises uniformly mixing palonosetron or a pharmaceutically acceptable salt thereof, a diluent, a disintegrant and a lubricant, and then making into a hard capsule.
3. Use of the pharmaceutical composition of claim 1 for the preparation of a medicament for the prevention and treatment of emesis.
CN201710478333.9A 2012-06-02 2012-06-02 Solid pharmaceutical composition of palonosetron Active CN107137374B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201710478333.9A CN107137374B (en) 2012-06-02 2012-06-02 Solid pharmaceutical composition of palonosetron

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN2012101865226A CN103446072A (en) 2012-06-02 2012-06-02 Palonosetron solid medicine composition
CN201710478333.9A CN107137374B (en) 2012-06-02 2012-06-02 Solid pharmaceutical composition of palonosetron

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN2012101865226A Division CN103446072A (en) 2012-06-02 2012-06-02 Palonosetron solid medicine composition

Publications (2)

Publication Number Publication Date
CN107137374A CN107137374A (en) 2017-09-08
CN107137374B true CN107137374B (en) 2020-04-07

Family

ID=49729194

Family Applications (2)

Application Number Title Priority Date Filing Date
CN201710478333.9A Active CN107137374B (en) 2012-06-02 2012-06-02 Solid pharmaceutical composition of palonosetron
CN2012101865226A Pending CN103446072A (en) 2012-06-02 2012-06-02 Palonosetron solid medicine composition

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN2012101865226A Pending CN103446072A (en) 2012-06-02 2012-06-02 Palonosetron solid medicine composition

Country Status (1)

Country Link
CN (2) CN107137374B (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107595824A (en) * 2017-09-21 2018-01-19 甘宜玲 A kind of anti-infectives tablet and preparation method thereof

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102048705A (en) * 2009-11-10 2011-05-11 齐鲁制药有限公司 Palonosetron hydrochloride orally disintegrating tablet and preparation method thereof

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008049552A1 (en) * 2006-10-24 2008-05-02 Helsinn Healthcare S.A. Soft capsules comprising palonosetron hydrochloride having improved stability and bioavailability

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102048705A (en) * 2009-11-10 2011-05-11 齐鲁制药有限公司 Palonosetron hydrochloride orally disintegrating tablet and preparation method thereof

Also Published As

Publication number Publication date
CN107137374A (en) 2017-09-08
CN103446072A (en) 2013-12-18

Similar Documents

Publication Publication Date Title
EP4324527A2 (en) Formulations of enzalutamide
KR20090073234A (en) Soft capsules comprising palonosetron hydrochloride having improved stability and bioavailability
US11279682B2 (en) Vortioxetine pyroglutamate
CN108272765B (en) Pharmaceutical composition containing vardenafil hydrochloride, orally disintegrating tablet, and preparation and application thereof
EP4079295A1 (en) Composition having improved solubility and bioavailability of olaparib
CN109662950B (en) Pharmaceutical composition containing dapoxetine hydrochloride
CN104940152B (en) A kind of pharmaceutical composition containing butanedioic acid Solifenacin
CN105560199B (en) A kind of children's domperidone oral disintegrating tablet and preparation method thereof
JP2021523195A (en) HC-1119 formulation and its manufacturing method and use
CN113368071A (en) Oral solid preparation containing vardenafil hydrochloride trihydrate and preparation method thereof
CN109908104B (en) Amoxicillin capsule and preparation method thereof
CN107137374B (en) Solid pharmaceutical composition of palonosetron
CN109157527B (en) Irbesartan capsule and preparation method thereof
CN104415034B (en) A kind of imidafenacin pharmaceutical composition and preparation method thereof
EP4268821A1 (en) Pharmaceutical composition containing pyrroloquinoline quinone trilithium salt nonahydrate compound, capsule, and preparation method therefor
CN114601803B (en) Ballon Sha Weizhi dry suspension and preparation method and application thereof
CN113827576A (en) Pharmaceutical composition with active ingredient of naloxone oxalate and preparation method thereof
CN114306258A (en) Acarbose solid oral preparation and preparation method thereof
CN110664761A (en) Lenalidomide pharmaceutical composition and preparation method thereof
Patil et al. Formulation and evaluation of fast dissolving tablets of granisetron hydrochloride by vacuum drying technique
CN118356426A (en) Pharmaceutical composition containing fused ring compound and preparation method and application thereof
EP3180029A1 (en) Afatinib pharmaceutical kit for cancer treatment
CN101134024A (en) Hydrochloric acid ondansetron oral cavity disintegrating lyophilized tablets and method for preparing the same
CN114010604A (en) Palbociclib solid preparation and preparation method thereof
WO2023172958A1 (en) Stable formulations of talabostat

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
GR01 Patent grant
GR01 Patent grant
CP03 Change of name, title or address
CP03 Change of name, title or address

Address after: No. 369, Yuzhou South Road, Lianyungang, Jiangsu Province

Patentee after: CHIA TAI TIANQING PHARMACEUTICAL GROUP Co.,Ltd.

Country or region after: China

Address before: 222062 Yuzhou South Road, Haizhou District, Lianyungang, Jiangsu 369

Patentee before: CHIA TAI TIANQING PHARMACEUTICAL GROUP Co.,Ltd.

Country or region before: China