CN106692098B - Cinacalcet hydrochloride quick releasing formulation and preparation method thereof - Google Patents

Cinacalcet hydrochloride quick releasing formulation and preparation method thereof Download PDF

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CN106692098B
CN106692098B CN201611265248.6A CN201611265248A CN106692098B CN 106692098 B CN106692098 B CN 106692098B CN 201611265248 A CN201611265248 A CN 201611265248A CN 106692098 B CN106692098 B CN 106692098B
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cinacalcet hydrochloride
particle
microcrystalline cellulose
label
present
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CN106692098A (en
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胡国宜
胡锦平
张孟
陈玮琦
奚小金
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CHANGZHOU SUNLIGHT PHARMACEUTICAL Co Ltd
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CHANGZHOU SUNLIGHT PHARMACEUTICAL Co Ltd
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    • 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
    • A61K9/2806—Coating materials
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • 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
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a kind of cinacalcet hydrochloride quick releasing formulation and preparation method thereof, which includes label and coating material, and label is made of the component of following weight percentage: cinacalcet hydrochloride 10%~50%；Pregelatinized starch 27%~54%；Microcrystalline cellulose 13%~26%；Polyvinylpyrrolidone 1%~5%；Crosslinked polyvinylpyrrolidone 1%~10%；Colloidal silicon dioxide 0.05%~2%；Magnesium stearate 0.05%~2%.Cinacalcet hydrochloride quick releasing formulation of the invention shows extraordinary dissolution rate, it is installed at 37 DEG C using USP2 and measures its dissolution rate in 0.05mol/L hydrochloric acid, the dissolution rate for only needing 15min that can reach 85% or more under the revolving speed of 75rpm and 50rpm, so as to the patient medication for being suitble to the WeiDongLi Capsules such as children and person in middle and old age not strong, the medication crowd of the product is expanded.

Description

Cinacalcet hydrochloride quick releasing formulation and preparation method thereof
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of cinacalcet hydrochloride quick releasing formulation and its preparation side Method.
Background technique
Cinacalcet hydrochloride is known as first drug in the new class compound of Sensipar, can activate in parathyroid gland Calcium receptor suffer from for treating the chronic kidney disease dialysed (CKD) to reduce the secretion of parathyroid hormone (PTH) The secondary hyperparathyroidism of person and the hypercalcinemia of parathyroid carcinoma patient；Cinacalcet hydrochloride belongs to BCS II Class drug, solubility are influenced significantly by pH, and limited solubility will lead to lower bioavilability.
Chinese patent literature CN1946382A discloses a kind of dissolution formulation of Galcium receptor-active compound, the dissolution formulation Cinacalcet hydrochloride comprising about 10% to about 40% weight ratio；The pregelatinized starch of about 5% to about 10% weight ratio；About 40% to about The microcrystalline cellulose of 75% weight ratio；The polyvinylpyrrolidone of about 1% to 5% weight ratio；The crosslinking of about 1% to about 10% weight ratio Polyvinylpyrrolidone.The dissolution formulation can further include the colloidal silicon dioxide of about 0.05% to about 1.5% weight ratio；About The magnesium stearate of 0.05% to about 1.5% weight ratio；The talcum powder of about 0.05% to about 1.5% weight ratio.The dissolution formulation can more into One step includes at least one coating material of about 0.05% to about 1.5% weight ratio.
Cinacalcet hydrochloride dissolution formulation dissolution rate disclosed in the document is bad, is installed on about 37 DEG C, 75rpm in USP2 Its dissolution rate in 0.05mol/L hydrochloric acid is measured under revolving speed, needs 30min that can reach 85% or more.In addition, 75rpm turns Speed is equivalent between twenty and fifty gastrointestinal motility intensity, if in the 50rpm revolving speed for being more suitable for children and person in middle and old age's gastrointestinal motility intensity Under be measured, then need 45min that can reach 85% or more dissolution rate, therefore cinacalcet hydrochloride disclosed in the document Dissolution formulation is not suitable for children or person in middle and old age's medication, target user's range have been more limited.
Summary of the invention
The purpose of the present invention is to solve the above problem, provide a kind of dissolution rate is very fast, be especially suitable for children and in it is old The cinacalcet hydrochloride quick releasing formulation and preparation method thereof of year medication.
Realizing the technical solution of the object of the invention is: a kind of cinacalcet hydrochloride quick releasing formulation, including label and coating material Material；The label is made of the component of following weight percentage: cinacalcet hydrochloride 10%~50%；Pregelatinized starch 27%~ 54%；Microcrystalline cellulose 13%~26%；Polyvinylpyrrolidone 1%~5%；Crosslinked polyvinylpyrrolidone 1%~10%；Colloidal state two Silica 0.05%~2%；Magnesium stearate 0.05%~2%.
The weight ratio of above-mentioned pregelatinized starch and microcrystalline cellulose is preferably 1.2: 1~2: 1, more preferably 1.5: 1.
The D of above-mentioned cinacalcet hydrochloride90100 μm of <.
The D of above-mentioned pregelatinized starch50100 μm of <, D90250 μm of <.
The D of above-mentioned microcrystalline cellulose50100 μm of <, D90250 μm of <.
Above-mentioned microcrystalline cellulose is present in particle, combines between particle or both.
Above-mentioned crosslinked polyvinylpyrrolidone is present in particle, combines between particle or both.
The weight of above-mentioned coating material is the 1%~6% of label weight.
Above-mentioned coating material is preferably stomach dissolved film coating pre-mix dose.
The preparation method of above-mentioned cinacalcet hydrochloride quick releasing formulation, has follow steps:
1. cinacalcet hydrochloride, pregelatinized starch, microcrystalline cellulose (in particle), the polyethylene pyrrole of Particle size requirements will be met Pyrrolidone and crosslinked polyvinylpyrrolidone (in particle) are uniformly mixed；
2. appropriate purified water is added as wetting agent, the granulation of 30 meshes is crossed, the particle prepared is put into 60 DEG C of baking ovens and is done It is dry, control pellet moisture≤5%；
3. the particle after drying is crossed into 24 mesh sieves, then with microcrystalline cellulose (outside particle), crosslinked polyethylene pyrroles Alkanone (outside particle) is uniformly mixed, then is uniformly mixed with colloidal silicon dioxide and magnesium stearate；
4. detecting midbody particle content, determines tabletting after slice weight, obtain label；
5. with coating material to gained label be coated to get.
The good effect that the present invention has: the present invention pass through a large number of experiments surprisingly it has been found that, pregelatinized starch and crystallite are fine The weight ratio for tieing up element has highly important influence for the dissolution rate of cinacalcet hydrochloride quick releasing formulation, works as pregelatinized starch Dosage when being higher than microcrystalline cellulose, especially for 1.2~2 times of microcrystalline cellulose dosage when, at more particularly 1.5 times, table Reveal extraordinary dissolution rate, is installed at 37 DEG C using USP2 and measures its dissolution rate in 0.05mol/L hydrochloric acid, The dissolution rate for only needing 15min that can reach 85% or more under the revolving speed of 75rpm and 50rpm, so as to be suitble to children in The not strong patient medication of the WeiDongLi Capsules such as old age expands the medication crowd of the product.
Specific embodiment
(embodiment 1)
The cinacalcet hydrochloride quick releasing formulation of the present embodiment is 25mg cinacalcet tablet.
The label of the 25mg cinacalcet tablet is made of the component of following weight percentage: 27.55% hydrochloric acid Xi Naka Plug；37.47% pregelatinized starch；24.98% microcrystalline cellulose；4% polyvinylpyrrolidone；4% crosslinked polyethylene pyrrole Pyrrolidone；1% colloidal silicon dioxide；1% magnesium stearate；Specifically it is shown in Table 1.
The preparation method of the 25mg cinacalcet tablet has follow steps:
1. by 27.55mg cinacalcet hydrochloride (D90100 μm of <), 37.47mg pregelatinized starch (D50100 μm of <, D90< 250 μm), 8.98mg microcrystalline cellulose (D50100 μm of <, D90250 μm of <, in particle), 4.00mg polyvinylpyrrolidone and 2.00mg crosslinked polyvinylpyrrolidone (in particle) is uniformly mixed.
2. appropriate purified water is added as wetting agent, the granulation of 30 meshes is crossed, the particle prepared is put into 60 DEG C of baking ovens and is done It is dry, control pellet moisture≤5%.
3. the particle after drying is crossed into 24 mesh sieves, then with 16.00mg microcrystalline cellulose (D50100 μm of <, D90< 250 μm, outside particle), 2.00mg crosslinked polyvinylpyrrolidone (outside particle) be uniformly mixed, then with 1.00mg colloidal silicon dioxide And 1.00mg magnesium stearate is uniformly mixed.
4. detecting midbody particle content, determines tabletting after slice weight, obtain the label of 100mg.
5. with 6.00mg stomach dissolved film coating pre-mix dose to gained label be coated to get.
(embodiment 2)
The cinacalcet hydrochloride quick releasing formulation of the present embodiment is 25mg cinacalcet tablet.
The preparation method is the same as that of Example 1 for the 25mg cinacalcet tablet, the difference is that label is by following weight percentage The component of ratio is made: 27.55% cinacalcet hydrochloride；31.20% pregelatinized starch；26.00% microcrystalline cellulose；4.25% Polyvinylpyrrolidone；8% crosslinked polyvinylpyrrolidone；1.50% colloidal silicon dioxide；1.50% magnesium stearate； Specifically it is shown in Table 1.
(embodiment 3)
The cinacalcet hydrochloride quick releasing formulation of the present embodiment is 75mg cinacalcet tablet.
The preparation method is the same as that of Example 1 for the 75mg cinacalcet tablet, the difference is that label is by following weight percentage The component of ratio is made: 41.325% cinacalcet hydrochloride；28.005% pregelatinized starch；18.67% microcrystalline cellulose；4% Polyvinylpyrrolidone；6% crosslinked polyvinylpyrrolidone；1% colloidal silicon dioxide；1% magnesium stearate；Specifically it is shown in Table 1。
(embodiment 4)
The cinacalcet hydrochloride quick releasing formulation of the present embodiment is 75mg cinacalcet tablet.
The preparation method is the same as that of Example 1 for the 75mg cinacalcet tablet, the difference is that label is by following weight percentage The component of ratio is made: 41.325% cinacalcet hydrochloride；30.95% pregelatinized starch；15.475% microcrystalline cellulose；4.25% Polyvinylpyrrolidone；6% crosslinked polyvinylpyrrolidone；1% colloidal silicon dioxide；1% magnesium stearate；It is specifically shown in Table 1.
Table 1
Note: purified water is removed (similarly hereinafter) during the preparation process.
(test case)
By 75mg made from 25mg cinacalcet tablet made from embodiment 1 and embodiment 2 and embodiment 3 and embodiment 4 Cinacalcet tablet is installed on 37 DEG C, dissolution rate of the measurement in 0.05mol/L hydrochloric acid under 75rpm revolving speed, knot with USP2 respectively Fruit is shown in Table 3.
By 75mg made from 25mg cinacalcet tablet made from embodiment 1 and embodiment 2 and embodiment 3 and embodiment 4 Cinacalcet tablet is installed on 37 DEG C, dissolution rate of the measurement in 0.05mol/L hydrochloric acid under 50rpm revolving speed, knot with USP2 respectively Fruit is shown in Table 4.
(1~comparative example of comparative example 2)
Comparative example 1 and comparative example 2 are respectively 25mg cinacalcet tablet and 75mg cinacalcet tablet, preparation method with Embodiment 1 is essentially identical, the difference is that dosage of each component, is specifically shown in Table 2.
Table 2
Component Comparative example 1 Comparative example 2
Cinacalcet hydrochloride 27.55mg 82.65mg
Pregelatinized starch (Starch1500) 50.06mg 150.2mg
Microcrystalline cellulose (in particle) (AvicelPH102) 10.02mg 30.05mg
Polyvinylpyrrolidone 3.07mg 9.20mg
Crosslinked polyvinylpyrrolidone (in particle) 1.85mg 5.55mg
Purified water In right amount In right amount
Microcrystalline cellulose (outside particle) (AvicelPH102) 51.45mg 154.35mg
Crosslinked polyvinylpyrrolidone (outside particle) 4.50mg 13.50mg
Colloidal silicon dioxide 0.75mg 2.25mg
Magnesium stearate 0.75mg 2.25mg
Label 150.00mg 450.00mg
Opadry II (coloured film forming agent) 6.00mg 18.00mg
Opadry II (transparent film forming agent) 2.25mg 6.75mg
Purified water In right amount In right amount
(contrast test example)
25mg cinacalcet tablet made from comparative example 1 and comparative example 2 and 75mg cinacalcet tablet are used into USP2 respectively It is installed on 37 DEG C, dissolution rate of the measurement in 0.05mol/L hydrochloric acid under 75rpm revolving speed, is as a result still shown in Table 3.
25mg cinacalcet tablet made from comparative example 1 and comparative example 2 and 75mg cinacalcet tablet are used into USP2 respectively It is installed on 37 DEG C, dissolution rate of the measurement in 0.05mol/L hydrochloric acid under 50rpm revolving speed, is as a result still shown in Table 4.
Table 3
Time/min Embodiment 1 Embodiment 2 Embodiment 3 Embodiment 4 Comparative example 1 Comparative example 2
15 96% 92% 94% 91% 83% 77%
30 98% 95% 96% 93% 91% 89%
45 98% 97% 96% 94% 95% 96%
60 99% 98% 98% 96% 97% 97%
Table 4
Time/min Embodiment 1 Embodiment 2 Embodiment 3 Embodiment 4 Comparative example 1 Comparative example 2
15 91% 88% 90% 87% 79% 73%
30 95% 92% 93% 90% 87% 84%
45 97% 95% 96% 92% 92% 90%
60 98% 96% 97% 94% 95% 96%
By table 3 and table 4 it can be seen that cinacalcet hydrochloride quick releasing formulation produced by the present invention has faster dissolution speed Degree is especially suitable for children and person in middle and old age's medication to improve its bioavilability in vivo.

Claims (4)

1. a kind of cinacalcet hydrochloride quick releasing formulation, including label and coating material；The label is by following weight percentage Component is made: cinacalcet hydrochloride 10%~50%；Pregelatinized starch 27%~54%；Microcrystalline cellulose 13%~26%；Polyethylene pyrrole Pyrrolidone 1%~5%；Crosslinked polyvinylpyrrolidone 1%~10%；Colloidal silicon dioxide 0.05%~2%；Magnesium stearate 0.05%~ 2%；
It is characterized by: the weight ratio of the pregelatinized starch and the microcrystalline cellulose is 1.5: 1；
The D of the cinacalcet hydrochloride90100 μm of <；
The D of the pregelatinized starch50100 μm of <, D90250 μm of <；
The D of the microcrystalline cellulose50100 μm of <, D90250 μm of <；
The preparation method of the cinacalcet hydrochloride quick releasing formulation has follow steps:
1. by the cinacalcet hydrochloride for meeting Particle size requirements, pregelatinized starch, being present in intragranular microcrystalline cellulose, polyethylene Pyrrolidones is uniformly mixed with intragranular crosslinked polyvinylpyrrolidone is present in；
2. appropriate purified water is added as wetting agent, the granulation of 30 meshes is crossed, the particle prepared is put into 60 DEG C of oven dryings, is controlled Make pellet moisture≤5%；
3. the particle after drying is crossed into 24 mesh sieves, then with the microcrystalline cellulose being present in outside particle, be present in outside particle Crosslinked polyvinylpyrrolidone be uniformly mixed, then be uniformly mixed with colloidal silicon dioxide and magnesium stearate；
4. detecting midbody particle content, determines tabletting after slice weight, obtain label；
5. with coating material to gained label be coated to get.
2. cinacalcet hydrochloride quick releasing formulation according to claim 1, it is characterised in that: the weight of the coating material is The 1%~6% of label weight.
3. cinacalcet hydrochloride quick releasing formulation according to claim 1, it is characterised in that: the coating material is stomach dissolution type Film coating pre-mix dose.
4. the preparation method of cinacalcet hydrochloride quick releasing formulation described in one of claims 1 to 3, it is characterised in that have following Step:
1. by the cinacalcet hydrochloride for meeting Particle size requirements, pregelatinized starch, being present in intragranular microcrystalline cellulose, polyethylene Pyrrolidones is uniformly mixed with intragranular crosslinked polyvinylpyrrolidone is present in；
2. appropriate purified water is added as wetting agent, the granulation of 30 meshes is crossed, the particle prepared is put into 60 DEG C of oven dryings, is controlled Make pellet moisture≤5%；
3. the particle after drying is crossed into 24 mesh sieves, then with the microcrystalline cellulose being present in outside particle, be present in outside particle Crosslinked polyvinylpyrrolidone be uniformly mixed, then be uniformly mixed with colloidal silicon dioxide and magnesium stearate；
4. detecting midbody particle content, determines tabletting after slice weight, obtain label；
5. with coating material to gained label be coated to get.
CN201611265248.6A 2016-12-30 2016-12-30 Cinacalcet hydrochloride quick releasing formulation and preparation method thereof Active CN106692098B (en)

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CN108815531B (en) * 2018-07-23 2021-04-30 深圳市优普惠药品股份有限公司 Novel pharmaceutic adjuvant and preparation method thereof
CN109700778B (en) * 2019-03-04 2021-08-13 南京恒生制药有限公司 Cinacalcet hydrochloride quick-release preparation and preparation method thereof
CN111450073A (en) * 2020-04-29 2020-07-28 福建海西新药创制有限公司 Pharmaceutical composition containing cinacalcet hydrochloride and preparation method thereof
CN112546010A (en) * 2020-12-02 2021-03-26 普莱赛思(天津)生命科技有限公司 Pharmaceutical composition for treating nephropathy and preparation method thereof

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EP2804588B1 (en) * 2012-01-17 2017-09-06 Zentiva Saglik Urunleri San. Ve Tic. A.S. Method for producing cinacalcet compositions for direct tableting
WO2015136329A1 (en) * 2014-03-14 2015-09-17 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Pharmaceutical composition of cinacalcet
CN105213346B (en) * 2015-11-02 2019-03-26 北京泰德制药股份有限公司 A kind of pharmaceutical composition and preparation method thereof containing cinacalcet hydrochloride

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