CN107982258A - A kind of Febustat releases pellet preparations, preparation method - Google Patents
A kind of Febustat releases pellet preparations, preparation method Download PDFInfo
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- CN107982258A CN107982258A CN201711294358.XA CN201711294358A CN107982258A CN 107982258 A CN107982258 A CN 107982258A CN 201711294358 A CN201711294358 A CN 201711294358A CN 107982258 A CN107982258 A CN 107982258A
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- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/426—1,3-Thiazoles
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- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
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- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- Life Sciences & Earth Sciences (AREA)
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Abstract
A kind of Febustat releases pellet preparations, preparation method, it is related to drug preparation technique and application field, the fast release micropill preparation administering mode is oral administration, using blank capsule core as carrier, tolvaptan aqueous solution containing cosolvent and adhesive is upper drug solns, the tolvaptan dosage, according to weight ratio, tolvaptan dosage is the 0.1%~1% of the capsule core；The oral dose of tolvaptan is not higher than 150 milligrams.The Febustat releases the features such as pellet preparations are good with medicine-feeding rate height, content uniformity, and drug release rapid-onset is fast.Meanwhile the fast release micropill preparation has the characteristics that Clinical practice compliance is good, safe.In addition, blank capsule core fluid bed medicine-feeding method is suitable for the preparation of tolvaptan drug oral preparation.
Description
Technical field
The present invention relates to drug preparation technique and application field, releases pellet preparations more particularly to a kind of Febustat, prepares
Method and its application.
Background technology
Febustat is listed by Japanese Di Ren companies in 04 beginning of the year in Japanese publication first, its end of the year is on U. S. application
City, IPSEN companies apply listing in Europe；Febustat is xanthine oxidase inhibitor of new generation, is clinically used to treat
The excessive disease of uric acid（Gout）.
Gout is due to caused by crystal uric acid deposits in joint and causes inflammatory reaction.The target for the treatment of is by serum uric acid
Level is reduced to below 6mg/dL, and current standard care medicine is allopurinol (allopurinol), belongs to xanthine oxidation
Enzyme inhibitor.
Gout is due to that internal generation uric acid is excessive and kidney Scavenging activity declines, and accumulation, causes in uric acid body
Urate crystal deposits in joint and each internal organs.Therefore, the means that the treatment of gout is usually taken are：Promote uric acid excretion and suppression
Antidiuresis acid generation, and related symptoms are improved using adequate measure.The generation of internal uric acid is related with purine metabolism, in purine metabolism
Final step in, hypoxanthine is in xanthine oxidoreductase enzyme（XOR）Under the action of generate xanthine, further generation urine
Acid, the generation of uric acid can effectively be reduced by suppressing the activity of XOR.
Over 40 years, allopurinol is that clinically only one is used for the medicine for suppressing uric acid generation, and as the Huang of gout
Golden medicine is widely used in clinic, and original achievement is achieved in the treatment of antigout.But due to allopurinol pair also
The XOR of prototype has inhibitory action, in allopurinol（And active metabolite oxypurinol）With in the interaction of XOR, XOR
It can spontaneously be reduced and activity recovery due to the molybdenum activated centre in enzyme；It is purine analogue additionally, due to allopurinol, can not
Avoid cause to be related to purine and pyridine is metabolized the influence of other enzymatic activitys.Therefore, it is necessary to repeat big agent in allopurinol treatment
Amount is administered to maintain higher levels of drugs.Thus also bring serious or even fatal bad anti-caused by drug accumulation
Should.Febustat is new non-purines XOR enzyme inhibitors, it has XOR the selectivity of height, and to oxidized form and also
The XOR of prototype has significant inhibitory action, and it is respectively 0.6 and 3.1nM that it, which suppresses Ki and Ki ' value of XOR,.And Febustat exists
Under up to 100 μM of concentration, the following enzymatic activity for being related to internal purine and pyridine metabolism is not influenced：Guanine deaminizating
Enzyme, hypoxanthine-guanine phosphoribosyl transferase, purine nucleoside phosphorylase, aromatic phosphoric acid phosphoribosynltransferase and whey
Sour nucleosides acid decarboxylase etc..And Febustat influences the inhibitory action of XOR from the redox state of enzyme.In vitro study
Display：Febustat is compared with allopurinol, not only with very high selectivity but also with stronger activity.Febustat presses down
The IC50 of XOR is respectively 114,118 and 210nmol/L in xanthine oxidase and mouse and rat liver in cow's milk processed, and other
The corresponding IC50 of fast alcohol is respectively 1700,380 and 1100nmol/L.Zooscopy shows that Febustat can significantly reduce small
The blood uric acid levels of mouse, rat and chimpanzee, its effect are significantly stronger than allopurinol.Mouse oral Febustat and purine
The ED50 values that alcohol reduces plasma uric acid level are respectively 0.7 and 2.7mg/kg；Febustat reduces rat in a dose-dependent manner
Plasma uric acid level, its effect are 10 times strong compared with allopurinol；For chimpanzee, Febustat and allopurinol reduce uric acid
50% dosage is respectively 2mg/kg and 5mg/kg.
Febustat oral absorption is complete, after administration 0.7~1.3 it is small when, blood concentration reaches peak value, and half-life period 2~8 is small
When, most of medicine is present in vivo with free state, and the 30% of dosage is excluded in the form of active compound through kidney.Medicine mainly passes through
Liver metabolism, different degrees of renal function situation do not influence pharmacokinetic parameter.
The content of the invention
The purpose of the present invention one is that providing a kind of Febustat of Orally-administrable releases pellet preparations.The purpose of the present invention
Two are to provide the preparation method that a kind of Febustat releases pellet preparations.
To achieve the above object, solution of the invention is：A kind of Febustat is provided and releases pellet preparations, the speed
Pellet preparations administering mode is released to be administered orally, using blank capsule core as carrier, the tolvaptan containing cosolvent and adhesive is water-soluble
Liquid is upper drug solns, the tolvaptan dosage, according to weight ratio, tolvaptan dosage for the capsule core 0.1%~
1%；The oral dose of tolvaptan is not higher than 150 milligrams.
Further, the blank capsule core is sucrose capsule core or microcrystalline cellulose capsule core.
Further, one or more of the cosolvent in citric acid, acetic acid, hydrochloric acid, ascorbic acid.
Further, according to weight ratio, cosolvent dosage is the 20%~300% of tolvaptan.
Further, the adhesive be selected from hydroxypropyl methylcellulose (HPMC), povidone (PVP), syrup, starch slurry,
One or more in carmethose, gelatin, Arabic gum, methylcellulose.
Further, according to weight ratio, binder dosage is the 0.18%~1.68% of blank capsule core.
Further, any one described Febustat releases pellet preparations and further includes protective layer membrane material；The protective layer
One or more of the membrane material in acrylic resin, hydroxypropyl methylcellulose.
Further, the Febustat releases pellet preparations, and according to weight ratio, the dosage of protective layer membrane material is blank
The 1.0%~5.0% of capsule core.
Further, the fast release micropill can be loaded on after capsule or addition proper auxiliary materials be pressed into after tablet take orally to
Medicine.
To achieve the above object, solution of the invention is：The preparation side that a kind of Febustat releases pellet preparations is provided
Method, using blank capsule core as carrier, using the tolvaptan aqueous solution containing cosolvent and adhesive as upper drug solns, using fluid bed bottom
Spray prescription method and prepare load medicine pellet, add protective layer membrane material solution and release pellet preparations through fluidized bed coating acquisition Febustat.
A kind of Febustat releases the preparation method of pellet preparations, including：
Step 1：The preparation of upper drug solns；
Step 2：Spray medicine in fluid bed bottom；
Step 3：Fluidized bed coating-protection film layer；
Step 4：After dry.
Further, the step 1 is specially to weigh tolvaptan by formula, and the citron acid solution for adding formula ratio is molten
Solution, is configured to quantitatively upper drug solns in the pure water solution for being then dissolved in including adhesive.
Further, the step 2 is specially and the blank capsule core of formula ratio is placed in fluid bed, starts fluid bed, to
The upper drug solns prepared in fluid bed in quantitative input step one.
Further, fluid bed medicine-feeding parameter is set by the process conditions of optimization during drug solns in the input, including
150~180m3h-1 of fan delivery, 2~7rmin-1 of feed flow revolution speed, 25~40 DEG C of temperature of charge, atomizing pressure
0.16MPa。
Further, the step 3 is specially to prepare 5% protective layer membrane material solution by formula ratio, and fluidized bed coating parameter is set
It is set to 150~180m3h-1 of fan delivery, feed flow 5~15rmin-1 of revolution speed, temperature of charge control is at 25~30 DEG C, mist
Change pressure 0.3MPa.Further, the step 4 is specially after the completion of being coated, to adjust fluid bed parameter, coating micro-pill is in 30
~40 DEG C of 15~45min of fluidized drying.
Embodiment
The above of the present invention is described in detail below in conjunction with specific embodiment, but this should not be interpreted as this hair
Bright technical solution is only limitted to following embodiments.
The formula of embodiment 11
| Tolvaptan | 800mg |
| Microcrystalline cellulose blank capsule core | 4000g |
| 0.3% acetum | 200ml |
| Hydroxypropyl methylcellulose (HPMC) | 300g |
| Talcum powder | 50g |
| Water | 5500g |
Preparation method：
(1) preparation of drug solns on：Tolvaptan 800mg is weighed by formula, adds 0.3% acetum 200mL dissolvings, then
It is dissolved in the aqueous solution for including hydroxypropyl methylcellulose (HPMC) 100g and is configured to drug solns on 1500g.
(2) medicine is sprayed at fluid bed bottom：Microcrystalline cellulose blank capsule core 4000g is placed in fluid bed, starts fluid bed, if
Put fluid bed medicine-feeding parameter:Fan delivery 150m3h-1, feed flow revolution speed 5rmin-1, temperature of charge control are 30~40
DEG C, atomizing pressure 0.16MPa, add medicine under fluidized state, after the completion of medicine-feeding, fluidized drying 15min.
(3) fluidized bed coating-protection film layer：Pure water 4100g is weighed by formula, lower add under stirring is stirred and adds into hydroxypropyl
Methylcellulose (HPMC) 200g, stirs dissolved clarification, and the protective layer membrane material solution that concentration is 5% is made, and adds talcum powder 50g, at a high speed
Emulsifying homogeneous 10 minutes, film layer coating solution must be protected by crossing 60 mesh sieves.Fluidized bed coating parameter is set：Fan delivery 180m3h-
1, feed flow revolution speed 15rmin-1, temperature of charge control are prevented under 25~35 DEG C, atomizing pressure 0.3MPa, fluidized state
Cuticular layer is coated.
(4) dry afterwards：After the completion of coating, coating micro-pill is in 30~40 DEG C of fluidized drying 30min.
The formula of embodiment 22
| Tolvaptan | 1500mg |
| Sucrose blank capsule core | 4000g |
| 0.1% citron acid solution | 300ml |
| Povidone (PVP) | 8g |
| Acrylic resin | 200g |
| Water | 5000g |
Preparation method：
(1) preparation of drug solns on：Tolvaptan 1500mg is weighed by formula, adds 0.1% citron acid solution 300mL dissolvings,
Drug solns on 1500g are configured in the aqueous solution for being then dissolved in including povidone (PVP) 8g.
(2) medicine is sprayed at fluid bed bottom：Sucrose blank capsule core 4000g is placed in fluid bed, starts fluid bed, fluidisation is set
Bed medicine-feeding parameter:Fan delivery 150m3h-1, feed flow revolution speed 5rmin-1, temperature of charge control are in 30~40 DEG C, atomization
Pressure 0.16MPa, adds medicine under fluidized state, after the completion of medicine-feeding, fluidized drying 15min.
(3) fluidized bed coating-protection film layer：Pure water about 3600g is weighed by formula, is added under stirring into acrylic resin
200g, stirs dissolved clarification, and the protective layer membrane material solution that concentration is 5% is made, and talcum powder 50g, high-speed emulsifying homogeneous are added under stirring
10 minutes, film layer coating solution must be protected by crossing 60 mesh sieves.Fluidized bed coating parameter is set：Fan delivery 180m3h-1, solution feed pump
Rotating speed 15rmin-1, temperature of charge control carry out protection film layer bag under 25~35 DEG C, atomizing pressure 0.3MPa, fluidized state
Clothing.(4) dry afterwards：After the completion of coating, coating micro-pill is in 30~40 DEG C of fluidized drying 30min.
The formula of embodiment 33
| Tolvaptan | 1800mg |
| Sucrose blank capsule core | 4000g |
| 0.6% hydrochloric acid solution | 700ml |
| Syrup | 70g |
| Acrylic resin | 200g |
| Water | 4500g |
Preparation method：
(1) preparation of drug solns on：Tolvaptan 1800mg is weighed by formula, adds 0.6% hydrochloric acid solution 700mL dissolvings, so
It is dissolved in afterwards in the aqueous solution for including syrup 70g and is configured to drug solns on 1500g.
(2) medicine is sprayed at fluid bed bottom：Sucrose blank capsule core 4000g is placed in fluid bed, starts fluid bed, fluidisation is set
Bed medicine-feeding parameter:Fan delivery 150m3h-1, feed flow revolution speed 5rmin-1, temperature of charge control are in 30~40 DEG C, atomization
Pressure 0.16MPa, adds medicine under fluidized state, after the completion of medicine-feeding, fluidized drying 15min.
(3) fluidized bed coating-protection film layer：Pure water about 3000g is weighed by formula, is added under stirring into acrylic resin
200g, stirs dissolved clarification, and concentration is made as 5% protective layer membrane material solution, addition talcum powder 60g, high-speed emulsifying homogeneous 10 minutes,
Film layer coating solution must be protected by crossing 60 mesh sieves.Fluidized bed coating parameter is set：Fan delivery 180m3h-1, feed flow revolution speed
15rmin-1, temperature of charge control carry out protection film layer coating under 25~35 DEG C, atomizing pressure 0.3MPa, fluidized state.
(4) dry afterwards：After the completion of coating, coating micro-pill is in 30~40 DEG C of fluidized drying 30min.
The formula of embodiment 44
| Tolvaptan | 100mg |
| Sucrose blank capsule core | 400g |
| 6% ascorbic acid solution | 100ml |
| Starch slurry | 0.8g |
| HPMC | 20g |
| Water | 500g |
Preparation method：
(1) preparation of drug solns on：Tolvaptan 100mg is weighed by formula, adds 6% ascorbic acid solution 100mL dissolvings, so
It is dissolved in afterwards in the aqueous solution for including starch slurry 0.8g and is configured to drug solns on 150g.
(2) medicine is sprayed at fluid bed bottom：Sucrose blank capsule core 400g is placed in fluid bed, starts fluid bed, fluidisation is set
Bed medicine-feeding parameter:Fan delivery 150m3h-1, feed flow revolution speed 2rmin-1, temperature of charge control are in 30~40 DEG C, atomization
Pressure 0.16MPa, adds medicine under fluidized state, after the completion of medicine-feeding, fluidized drying 15min.
(3) fluidized bed coating-protection film layer：Pure water about 350g is weighed by formula, stirs lower addition HPMC 20g, stirring is molten
Clearly, the protective layer membrane material solution that concentration is 5% is made, adds talcum powder 6g, high-speed emulsifying homogeneous 10 minutes, crossing 60 mesh sieves must prevent
Cuticular layer coating solution.Fluidized bed coating parameter is set：Fan delivery 180m3h-1, feed flow revolution speed 5rmin-1, material temperature
Degree control carries out protection film layer coating under 25~35 DEG C, atomizing pressure 0.3MPa, fluidized state.
(4) dry afterwards：After the completion of coating, coating micro-pill is in 30~40 DEG C of fluidized drying 30min.
The formula of embodiment 55
| Tolvaptan | 150mg |
| Sucrose blank capsule core | 4000g |
| 0.1% citric acid soln | 200ml |
| Carmethose | 70g |
| HPMC | 200g |
| Water | 5000g |
Preparation method：
(1) preparation of drug solns on：Tolvaptan 150mg is weighed by formula, adds 0.1% citric acid soln 200mL dissolvings, so
It is dissolved in afterwards in the aqueous solution for including carmethose 70g and is configured to drug solns on 1500g.
(2) medicine is sprayed at fluid bed bottom：Sucrose blank capsule core 4000g is placed in fluid bed, starts fluid bed, fluidisation is set
Bed medicine-feeding parameter:Fan delivery 150m3h-1, feed flow revolution speed 5rmin-1, temperature of charge control are in 30~40 DEG C, atomization
Pressure 0.16MPa, adds medicine under fluidized state, after the completion of medicine-feeding, fluidized drying 15min.
(3) fluidized bed coating-protection film layer：Pure water about 3500g is weighed by formula, stirs lower addition HPMC 200g, stirring
Dissolved clarification, is made the protective layer membrane material solution that concentration is 5%, adds talcum powder 20g, high-speed emulsifying homogeneous 10 minutes, crosses 60 mesh sieves
Film layer coating solution must be protected.Fluidized bed coating parameter is set：Fan delivery 180m3h-1, feed flow revolution speed 12rmin-1,
Temperature of charge control carries out protection film layer coating under 25~35 DEG C, atomizing pressure 0.3MPa, fluidized state.
(4) dry afterwards：After the completion of coating, coating micro-pill is in 30~40 DEG C of fluidized drying 30min.
Claims (10)
1. a kind of Febustat releases pellet preparations, it is characterised in that the fast release micropill preparation administering mode is oral administration,
Using blank capsule core as carrier, the tolvaptan aqueous solution containing cosolvent and adhesive is upper drug solns, and the tolvaptan is used
Amount, according to weight ratio, tolvaptan dosage is the 0.1~1% of the capsule core；The oral dose of tolvaptan is not higher than 150 millis
Gram.
2. Febustat as claimed in claim 1 releases pellet preparations, it is characterised in that the blank capsule core is sucrose capsule core
Or microcrystalline cellulose capsule core；One or more of the cosolvent in citric acid, acetic acid, hydrochloric acid, ascorbic acid or according to
Weight ratio, cosolvent dosage are the 20~300% of tolvaptan.
3. Febustat as claimed in claim 1 releases pellet preparations, it is characterised in that it is fine that the adhesive is selected from hydroxypropyl first
The one or more in element, povidone, syrup, starch slurry, carmethose, gelatin, Arabic gum, methylcellulose are tieed up,
According to weight ratio, binder dosage is the 0.18~1.68% of blank capsule core.
4. any one Febustat releases pellet preparations as described in claims 1 to 3, it is characterised in that further includes protection tunic
Material；One or more of the protective layer membrane material in acrylic resin, hydroxypropyl methylcellulose；According to weight ratio, protection
The dosage of tunic material is the 1.0~5.0% of blank capsule core.
5. any one Febustat releases pellet preparations as described in Claims 1 to 4, it is characterised in that the fast release micropill
Be loaded on capsule or addition proper auxiliary materials after be pressed into tablet after be administered orally.
6. a kind of Febustat releases the preparation method of pellet preparations, it is characterised in that using blank capsule core as carrier, with containing cosolvent
And the tolvaptan aqueous solution of adhesive is upper drug solns, prescription method is sprayed using fluid bed bottom and prepares load medicine pellet, is added anti-
Sheath membrane material solution obtains Febustat through fluidized bed coating and releases pellet preparations.
7. a kind of Febustat releases the preparation method of pellet preparations, including：
Step 1：The preparation of upper drug solns；
Step 2：Spray medicine in fluid bed bottom；
Step 3：Fluidized bed coating-protection film layer；
Step 4：After dry.
8. preparation method as claimed in claim 7, it is characterised in that the step 1 be specially by formula weigh support cut down it is general
It is smooth, the citron acid solution dissolving of formula ratio is added, it is molten to be configured to quantitative medicine-feeding in the aqueous solution for being then dissolved in including adhesive
Liquid.
9. preparation method as claimed in claim 7, it is characterised in that the step 2 is specially by the blank capsule core of formula ratio
It is placed in fluid bed, starts fluid bed, the upper drug solns prepared into fluid bed in quantitative input step one, the input medicine-feeding
Fluid bed medicine-feeding parameter, including 150~180m3h-1 of fan delivery, solution feed pump is set to turn by the process conditions of optimization during solution
2~7rmin-1 of speed, 25~40 DEG C of temperature of charge, atomizing pressure 0.16MPa.
10. preparation method as claimed in claim 7, it is characterised in that the step 3 is specially to prepare 5% by formula ratio to prevent
Sheath membrane material solution, fluidized bed coating parameter are arranged to 150~180m3h-1 of fan delivery, 5~15rmin- of feed flow revolution speed
1, temperature of charge control is at 25~30 DEG C, atomizing pressure 0.3MPa；The step 4 is specially after the completion of being coated, to adjust fluid bed
Parameter, coating micro-pill is in 30~40 DEG C of 15~45min of fluidized drying.
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