CN101185623A - Mycophenolate mofetil dry suspension agent - Google Patents
Mycophenolate mofetil dry suspension agent Download PDFInfo
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- CN101185623A CN101185623A CNA2007100931018A CN200710093101A CN101185623A CN 101185623 A CN101185623 A CN 101185623A CN A2007100931018 A CNA2007100931018 A CN A2007100931018A CN 200710093101 A CN200710093101 A CN 200710093101A CN 101185623 A CN101185623 A CN 101185623A
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Abstract
The invention discloses a mycophenolate mofetil dry suspension, which consists of the following components and contents (weight unit): 125-600 portions of mycophenolate mofetil, 400-1000 portions of loading agents, 10-60 portions of sweetening agents, 50-100 portions of suspending agents, and appropriate quantity of wetting agents. The dry suspension has the advantages of easy administration, large production, easy quality control and convenient administration of patients.
Description
Technical field
The present invention relates to a kind of mycophenolate mofetil dry suspension agent.
Background technology
(Mycophenolate Mofetil is that (MycophenolicAcid, 2-ethyl ester analog derivative MPA) form MPA through taking off ester to mycophenolic acid in vivo MMF) to Mycophenolate Mofetil.It is a kind of novel immunosuppressant, has the oral administration biaavailability height, can specific effect in lymphocyte, side effect such as no Liver and kidney toxicity and bone marrow depression can be safely and other immunosuppressant use in conjunction.
The Mycophenolate Mofetil dosage form of listing only has capsule and lyophilized injectable powder at present, for adapting to all ages and classes patient's compliance, needs the further novel form of exploitation Mycophenolate Mofetil.
Summary of the invention
Technical problem to be solved by this invention provides the dry suspension type of Mycophenolate Mofetil.
Mycophenolate mofetil dry suspension agent of the present invention comprises following component and content (weight portion):
125～600 parts of Mycophenolate Mofetil
400～1000 parts of filleies
10～60 parts of sweeting agents
50～100 parts of suspending agents
Wetting agent is an amount of.
The content of described mycophenolate mofetil dry suspension agent is preferably:
400～600 parts of Mycophenolate Mofetil
700～900 parts of filleies
20～50 parts of sweeting agents
60～90 parts of suspending agents
Wetting agent is an amount of.
Above-mentioned filler is selected from any one in sucrose, lactose, microcrystalline Cellulose, starch, mannitol and the sorbitol, preferably sucrose.
Above-mentioned sweeting agent is selected from any one in steviosin, aspartame, glucide and the xylitol, preferred steviosin.
Above-mentioned suspending agent is selected from any one in hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, arabic gum, xanthan gum and the methylcellulose, preferred hydroxypropyl emthylcellulose.
Above-mentioned wetting agent is any one in ethanol, distilled water, propylene glycol, the glycerol, preferred distilled water.
Most preferred component of described mycophenolate mofetil dry suspension agent and content (weight portion) are as follows:
500 parts of Mycophenolate Mofetil
890 parts of sucrose
30 parts of steviosin
80 parts of hydroxypropyl emthylcelluloses
Distilled water is an amount of.
As oral dry suspension type, it have taking convenience, volume of production big, be convenient to quality control, be beneficial to advantages such as the patient takes.The supplementary product kind of mycophenolate mofetil dry suspension agent of the present invention is few, and cost is low, and consumption is suitable.Gained suspensoid settling volume is all more qualified than, uniformity of dosage units, meets the pertinent regulations under Chinese Pharmacopoeia two editions appendix oral suspensions items in 2005.
With mycophenolate mofetil dry suspension agent of the present invention (sample lot number: 030,513 030,514 030515), carry out accelerated test, put into the hermetic container of RH75% (sodium chloride saturated solution) by commercially available back, in 40 ℃ of calorstats, 1,2,3, each sampling in June once, detect every index.The results are shown in Table 1.
40 ℃ of table 1 mycophenolate mofetil dry suspension agents, six months accelerated tests of 75%RH
| Lot number | Time (moon) | The investigation project | |||||
| Appearance luster | The settling volume ratio | Acidity | Content (%) | The always assorted rate (%) of related substance (%) | Microbial limit | ||
| 030513 | 0 | White or off-white powder, it is sweet to distinguish the flavor of | 0.96 | 6.4 | 100.36 | 0.132 | Qualified |
| 1 | White or off-white powder, it is sweet to distinguish the flavor of | 0.95 | 6.5 | 101.81 | 0.120 | Qualified | |
| 2 | White or off-white powder, it is sweet to distinguish the flavor of | 0.93 | 6.7 | 98.51 | 0.390 | Qualified | |
| 3 | White or off-white powder, it is sweet to distinguish the flavor of | 0.94 | 6.7 | 97.77 | 0.332 | Qualified | |
| 6 | White or off-white powder, it is sweet to distinguish the flavor of | 0.95 | 6.8 | 98.66 | 0.316 | Qualified | |
| 030514 | 0 | White or off-white powder, it is sweet to distinguish the flavor of | 0.98 | 6.5 | 102.51 | 0.102 | Qualified |
| 1 | White or off-white powder, it is sweet to distinguish the flavor of | 0.96 | 6.5 | 101.56 | 0.129 | Qualified | |
| 2 | White or off-white powder, it is sweet to distinguish the flavor of | 0.96 | 6.6 | 100.98 | 0.321 | Qualified | |
| 3 | White or off-white powder, it is sweet to distinguish the flavor of | 0.96 | 6.6 | 101.27 | 0.348 | Qualified | |
| 6 | White or off-white powder, it is sweet to distinguish the flavor of | 0.94 | 6.7 | 99.40 | 0.333 | Qualified | |
| 030515 | 0 | White or off-white powder, it is sweet to distinguish the flavor of | 0.97 | 6.3 | 100.69 | 0.123 | Qualified |
| 1 | White or off-white powder, it is sweet to distinguish the flavor of | 0.96 | 6.4 | 99.74 | 0.138 | Qualified | |
| 2 | White or off-white powder, it is sweet to distinguish the flavor of | 0.95 | 6.5 | 98.00 | 0.363 | Qualified | |
| 3 | White or off-white powder, it is sweet to distinguish the flavor of | 0.95 | 6.8 | 97.79 | 0.349 | Qualified | |
| 6 | White or off-white powder, it is sweet to distinguish the flavor of | 0.94 | 6.7 | 98.52 | 0.285 | Qualified |
As seen mycophenolate mofetil dry suspension agent is under the commercially available back condition, 40 ℃ * RH75% environment place down six months more stable, removing related substance slightly increases, its every index does not have significant change.
With mycophenolate mofetil dry suspension agent of the present invention (sample lot number: 030,513 030,514 030515), carry out the long-term investigation test, mycophenolate mofetil dry suspension agent is pressed commercially available back, place 25 ℃, the biochemical incubator of 60%RH, regularly sampling detects every index, the results are shown in Table 2.
Table 2 mycophenolate mofetil dry suspension agent keep sample for a long time (25 ℃, RH60%) investigate
| Lot number | Time (moon) | The investigation project | |||
| Appearance luster | The settling volume ratio | Acidity | Content (%) | The always assorted rate (%) of related substance (%) | Microbial limit |
| 030513 | 0 | White or off-white powder, it is sweet to distinguish the flavor of | 0.96 | 6.4 | 100.36 | 0.132 | Qualified |
| 3 | White or off-white powder, it is sweet to distinguish the flavor of | 0.95 | 6.5 | 100.78 | 0.131 | Qualified | |
| 6 | White or off-white powder, it is sweet to distinguish the flavor of | 0.93 | 6.7 | 99.57 | 0.120 | Qualified | |
| 9 | White or off-white powder, it is sweet to distinguish the flavor of | 0.93 | 6.5 | 99.24 | 0.159 | Qualified | |
| 12 | White or off-white powder, it is sweet to distinguish the flavor of | 0.94 | 6.5 | 99.23 | 0.162 | Qualified | |
| 18 | White or off-white powder, it is sweet to distinguish the flavor of | 0.93 | 6.6 | 101.5 | 0.301 | Qualified | |
| 24 | White or off-white powder, it is sweet to distinguish the flavor of | 0.92 | 6.7 | 102.2 | 0.234 | Qualified | |
| 030514 | 0 | White or off-white powder, it is sweet to distinguish the flavor of | 0.98 | 6.5 | 102.51 | 0.102 | Qualified |
| 3 | White or off-white powder, it is sweet to distinguish the flavor of | 0.95 | 6.5 | 99.29 | 0.174 | Qualified | |
| 6 | White or off-white powder, it is sweet to distinguish the flavor of | 0.94 | 6.6 | 100.17 | 0.133 | Qualified | |
| 9 | White or off-white powder, it is sweet to distinguish the flavor of | 0.93 | 6.7 | 99.59 | 0.159 | Qualified | |
| 12 | White or off-white powder, it is sweet to distinguish the flavor of | 0.93 | 6.8 | 98.94 | 0.176 | Qualified | |
| 18 | White or off-white powder, it is sweet to distinguish the flavor of | 0.93 | 6.8 | 102.1 | 0.270 | Qualified | |
| 24 | White or off-white powder, it is sweet to distinguish the flavor of | 0.92 | 6.9 | 100.7 | 0.256 | Qualified | |
| 030515 | 0 | White or off-white powder, it is sweet to distinguish the flavor of | 0.97 | 6.3 | 100.69 | 0.123 | Qualified |
| 3 | White or off-white powder, it is sweet to distinguish the flavor of | 0.96 | 6.4 | 99.28 | 0.147 | Qualified | |
| 6 | White or off-white powder, it is sweet to distinguish the flavor of | 0.93 | 6.5 | 99.04 | 0.105 | Qualified | |
| 9 | White or off-white powder, it is sweet to distinguish the flavor of | 0.94 | 6.6 | 98.05 | 0.156 | Qualified | |
| 12 | White or off-white powder, it is sweet to distinguish the flavor of | 0.92 | 6.6 | 98.44 | 0.211 | Qualified | |
| 18 | White or off-white powder, it is sweet to distinguish the flavor of | 0.93 | 6.7 | 100.9 | 0.270 | Qualified | |
| 24 | White or off-white powder, it is sweet to distinguish the flavor of | 0.94 | 6.7 | 101.8 | 0.255 | Qualified |
Long-term test results shows, this product was placed 2 years under 25 ℃, the condition of RH60%, and every after testing index is all qualified, thus these product place 2 years stable.
With mycophenolate mofetil dry suspension agent of the present invention (the sample lot number is 051212,051215,051217), put under 25 ℃, RH60% condition by commercially available back, respectively at sampling in 3,6,9,12,18 months, detect every index, the results are shown in following table:
| Lot number | Time (moon) | Character | Content (%) | Related substance (%) |
| 051212 | 0 | White powder, it is sweet to distinguish the flavor of | 101.5 | 0.04 |
| 3 | Off-white powder, it is sweet to distinguish the flavor of | 100.9 | 0.10 | |
| 6 | Off-white powder, it is sweet to distinguish the flavor of | 96.6 | 0.14 | |
| 9 | Off-white powder, it is sweet to distinguish the flavor of | 98.1 | 0.09 | |
| 12 | Off-white powder, it is sweet to distinguish the flavor of | 96.7 | 0.11 | |
| 18 | Off-white powder, it is sweet to distinguish the flavor of | 97.6 | 0.09 | |
| 051215 | 0 | White powder, it is sweet to distinguish the flavor of | 102.1 | 0.03 |
| 3 | Off-white powder, it is sweet to distinguish the flavor of | 100.0 | 0.08 | |
| 6 | Off-white powder, it is sweet to distinguish the flavor of | 98.1 | 0.13 | |
| 9 | Off-white powder, it is sweet to distinguish the flavor of | 99.4 | 0.11 | |
| 12 | Off-white powder, it is sweet to distinguish the flavor of | 98.7 | 0.13 | |
| 18 | Off-white powder, it is sweet to distinguish the flavor of | 97.27 | 0.10 |
| 051217 | 0 | White powder, it is sweet to distinguish the flavor of | 103.2 | 0.08 |
| 3 | Off-white powder, it is sweet to distinguish the flavor of | 99.7 | 0.09 | |
| 6 | Off-white powder, it is sweet to distinguish the flavor of | 98.8 | 0.12 | |
| 9 | Off-white powder, it is sweet to distinguish the flavor of | 101.9 | 0.11 | |
| 12 | Off-white powder, it is sweet to distinguish the flavor of | 98.9 | 0.11 | |
| 18 | Off-white powder, it is sweet to distinguish the flavor of | 97.74 | 0.11 |
This long-term test results shows, this product was placed 18 months under 25 ℃, the condition of RH60%, and every after testing index is all qualified, thus these product place 18 months stable.
We have carried out the bioequivalence test of mycophenolate mofetil dry suspension agent in addition.
Mycophenolate Mofetil sheet (MMF): ICN Dutch Holdings B.V, Humacao, PR produces, the company limited packing of Shanghai Roche Group
Dosage regimen: binary cycle two preparation trial design are adopted in test, and experimenter 20 people are divided into two groups at random.Oral test preparation mycophenolate mofetil dry suspension agent 1 bag (500mg), or 1 of reference preparation MMF (500mg) respectively intersects after the week and takes medicine.Take (dry suspension with a small amount of warm water suspendible then take) with about 250ml drinking water.Administration can be drunk water after 2 hours, 4 hours laggard unified standard meal of administration.
Evaluation criterion: finish blood drug level-time data of Bioavailability of Human Body and bioequivalence process of the test experimenter thereof,, and carry out evaluation of bioequivalence after handling by statistics with BAPP computed in software pharmacokinetic parameter.With two preparation AUC meansigma methods ratios 80～125% as bioequivalent criterion.
Statistical method: all are finished pharmacokinetics process of the test experimenter blood drug level-time data through BAPP computed in software pharmacokinetic parameter, all programs and raw data all stay shelves, the measurement data descriptive statistics adopts mean ± standard deviation, will adopt methods such as t check, variance analysis to carry out statistical inference.
The result:
(1) Mycophenolate Mofetil sheet (MMF) is a reference preparation, uses area-method AUC
0-72And AUC
0-∞The relative bioavailability F of estimation mycophenolate mofetil dry suspension agent of the present invention
1And F
2Be respectively 100.93 ± 15.04% and 100.15 ± 12.51%, bioavailability meets the requirements.
Behind (2) 20 the oral 500mg of experimenter mycophenolate mofetil dry suspension agents of the present invention, the half-life of estimation is 16.80 ± 4.01h, and peak time and peak concentration are respectively 0.40 ± 0.10h and 19.29 ± 6.78ug/ml, AUC
0-72Be 39.22 ± 10.43ugh/ml, AUC
0-∞Be 40.58 ± 10.49ugh/ml.The half-life of estimating behind the oral Mycophenolate Mofetil sheet is 16.77 ± 4.10h, and peak time is 0.7 ± 0.4h, and peak concentration is 18.22 ± 7.19ug/ml, AUC
0-72Be 39.38 ± 10.46ugh/ml, AUC
0-∞Be 41.00 ± 10.49ugh/ml ± 10.88ugh/ml.Tmax non parametric tests result shows, reference preparation and be subjected to test preparation difference that the significance meaning is arranged, the absorption rate of mycophenolate mofetil dry suspension agent illustrates that significantly greater than Mycophenolate Mofetil sheet (p＜0.05) two kinds of preparations difference on absorption rate has the significance meaning.The Cmax, the AUC that show two kinds of preparations through variance analysis
0-72And AUC
0-∞No significant difference (p＞0.05) is further with couple Cmax, the AUC of two kinds of preparations of one-side t check analyses demonstration
0-72And AUC
0-∞Bioequivalence promptly shows two kinds of preparations bioequivalence aspect degree of absorption.
Conclusion: mycophenolate mofetil dry suspension agent of the present invention and Mycophenolate Mofetil sheet difference on absorption rate have the significance meaning, the absorption rate of mycophenolate mofetil dry suspension agent is significantly greater than the Mycophenolate Mofetil sheet, and two kinds of preparations bioequivalence aspect degree of absorption.
The present invention is further detailed explanation below in conjunction with the specific embodiment.
The specific embodiment
Embodiment 1
Mycophenolate Mofetil 500g
Microcrystalline Cellulose 900g
Aspartame 20g
Sodium carboxymethyl cellulose 60g
Ethanol is an amount of
Preparation method is as follows:
(1) the precision Mycophenolate Mofetil that takes by weighing recipe quantity is crossed 100 mesh sieves.
(2) precision takes by weighing microcrystalline Cellulose, aspartame, the sodium carboxymethyl cellulose of recipe quantity, and behind mistake 100 mesh sieves, equivalent is progressively increased step by step, mix homogeneously respectively.
(3) (1) and (2) equivalent is progressively increased step by step, mix homogeneously must mix powder.
(4) will mix powder and add an amount of ethanol system soft material, 40 orders are granulated.
(5) 40～70 ℃ of oven dry, 40 order granulate.
(6) intermediate detection qualified after, packing gets product.
Embodiment 2
Mycophenolate Mofetil 500g
Sucrose 890g
Steviosin 30g
Hydroxypropyl emthylcellulose 80g
Distilled water is an amount of
Preparation method is with embodiment 1.
This optimization formula, the controllability of its preparation process that to be us higher at drug content in the stability of principal agent in suspensoid and this product and cause, and the settling volume of dry suspension quality index than and outward appearance, flowability be main starting point, carry out prescription screening and get.The selection result such as following table:
| The name of an article, evaluation | 1 2 3 4 5 6 | |
| Mycophenolate Mofetil microcrystalline Cellulose sorbitol lactose sucrose steviosin hydroxypropyl emthylcellulose sodium carboxymethyl cellulose distilled water | 500 500 500 500 500 500 900------900------900------890 900 900 10 20 25 30 40 45---80 100 60 30 30 30----an amount of an amount of | |
| Screening index | The situation of granulating angle of repose outward appearance settling volume compares sweet taste | 43.6 ° of 34.6 ° 34.7 ° 33.5 ° 35.9 ° 36.5 ° general general even fine powder bulky grain single-size single-size single-size single-sizes 0.6 0.2 0.87 0.96 0.88 0.96 are sweetless sweetless suitable too sweet too sweet |
Embodiment 3
Mycophenolate Mofetil 250g
Mannitol 450g
Xylitol 15g
Methylcellulose 45g
Propylene glycol is an amount of
Preparation method is with embodiment 1.
Embodiment 4
Mycophenolate Mofetil 125g
Lactose 225g
Glucide 10g
Arabic gum 25g
Glycerol is an amount of
Preparation method is with embodiment 1.
Embodiment 5
Mycophenolate Mofetil 125g
Sorbitol 225g
Aspartame 10g
Xanthan gum 25g
Propylene glycol is an amount of
Preparation method is with embodiment 1.
Claims (10)
1. a mycophenolate mofetil dry suspension agent is characterized in that, comprises following component and content (weight portion):
125～600 parts of Mycophenolate Mofetil
400～1000 parts of filleies
10～60 parts of sweeting agents
50～100 parts of suspending agents
Wetting agent is an amount of.
2. according to the described mycophenolate mofetil dry suspension agent of claim 1, it is characterized in that, comprise following component and content (weight portion):
400～600 parts of Mycophenolate Mofetil
700～900 parts of filleies
20～50 parts of sweeting agents
60～90 parts of suspending agents
Wetting agent is an amount of.
3. according to claim 1 or 2 described mycophenolate mofetil dry suspension agents, it is characterized in that described filler is selected from any one in sucrose, lactose, microcrystalline Cellulose, starch, mannitol and the sorbitol.
4. state mycophenolate mofetil dry suspension agent according to claim 3, it is characterized in that, described filler is a sucrose.
5. according to claim 1 or 2 described mycophenolate mofetil dry suspension agents, it is characterized in that described sweeting agent is selected from any one in steviosin, aspartame, glucide and the xylitol.
6. state mycophenolate mofetil dry suspension agent according to claim 5, it is characterized in that, described sweeting agent is a steviosin.
7. according to claim 1 or 2 described mycophenolate mofetil dry suspension agents, it is characterized in that described suspending agent is selected from any one in hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, arabic gum, xanthan gum and the methylcellulose.
8. state mycophenolate mofetil dry suspension agent according to claim 7, it is characterized in that, described suspending agent is a hydroxypropyl emthylcellulose.
9. according to claim 1 or 2 described mycophenolate mofetil dry suspension agents, it is characterized in that described wetting agent is any one in ethanol, distilled water, propylene glycol, the glycerol.
10. a mycophenolate mofetil dry suspension agent is characterized in that, comprises following component and content (weight portion):
500 parts of Mycophenolate Mofetil
890 parts of sucrose
30 parts of steviosin
80 parts of hydroxypropyl emthylcelluloses
Distilled water is an amount of.
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| CN200710093101A CN100574761C (en) | 2007-12-04 | 2007-12-04 | Mycophenolate mofetil dry suspension agent |
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|---|---|---|---|
| CN200710093101A CN100574761C (en) | 2007-12-04 | 2007-12-04 | Mycophenolate mofetil dry suspension agent |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101926776A (en) * | 2010-08-13 | 2010-12-29 | 清远容大生物工程有限公司 | Salinomycin sodium suspension as well as preparation method and application thereof |
| WO2011117883A1 (en) * | 2010-03-23 | 2011-09-29 | Alkem Laboratories Ltd. | Pharmaceutical composition of mycophenolate mofetil and process for preparing thereof |
| CN106913531A (en) * | 2015-12-25 | 2017-07-04 | 山东新时代药业有限公司 | A kind of MMF freeze-dried composition and preparation method thereof |
| WO2018167628A1 (en) | 2017-03-13 | 2018-09-20 | Ftf Pharma Private Limited | Pharmaceutical composition of oral suspension of immunosuppressive agents |
-
2007
- 2007-12-04 CN CN200710093101A patent/CN100574761C/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011117883A1 (en) * | 2010-03-23 | 2011-09-29 | Alkem Laboratories Ltd. | Pharmaceutical composition of mycophenolate mofetil and process for preparing thereof |
| CN101926776A (en) * | 2010-08-13 | 2010-12-29 | 清远容大生物工程有限公司 | Salinomycin sodium suspension as well as preparation method and application thereof |
| CN101926776B (en) * | 2010-08-13 | 2012-07-18 | 清远容大生物工程有限公司 | Salinomycin sodium suspension as well as preparation method and application thereof |
| CN106913531A (en) * | 2015-12-25 | 2017-07-04 | 山东新时代药业有限公司 | A kind of MMF freeze-dried composition and preparation method thereof |
| CN106913531B (en) * | 2015-12-25 | 2020-05-01 | 山东新时代药业有限公司 | Mycophenolate mofetil freeze-dried composition and preparation method thereof |
| WO2018167628A1 (en) | 2017-03-13 | 2018-09-20 | Ftf Pharma Private Limited | Pharmaceutical composition of oral suspension of immunosuppressive agents |
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| Publication number | Publication date |
|---|---|
| CN100574761C (en) | 2009-12-30 |
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