CN104257611B - Pharmaceutical composition containing micronized fexofenadine hydrochloride - Google Patents
Pharmaceutical composition containing micronized fexofenadine hydrochloride Download PDFInfo
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Abstract
The invention provides micronized fexofenadine hydrochloride. The particle size of fexofenadine hydrochloride at 95% cumulative volume is 60mu m or below. The invention also provides a method for preparing the micronized fexofenadine hydrochloride, a pharmaceutical composition containing the micronized fexofenadine hydrochloride, as well as a preparation method of the pharmaceutical composition. According to the invention, a solid preparation by taking the micronized fexofenadine hydrochloride as the active ingredient has excellent dissolution rate in vitro and has high dissolution characteristics under various pH conditions, the corresponding effects of the medicine in vivo in different crowds can be effectively guaranteed, and the problem that the bioavailability of the medicine in vivo is reduced so as to influence the curative effect because the conventional fexofenadine hydrochloride medicine is difficult to dissolve in an in-vivo gastrointestinal environment is solved.
Description
Technical field
The present invention relates to field of medicaments, particularly relate to a kind of containing micronization fexofenadine hydrochloride pharmaceutical composition and pharmaceutical preparation thereof.
Background technology
Fexofenadine hydrochloride is a kind of second filial generation H1 receptor antagonist, and be the carboxylated metabolite of teldane, it optionally blocks H1 receptor, has good antihistamine effect, but without anti-five hydroxytryptamine, cholinolytic and adrenolytic.
Zooscopy shows, the bronchospasm that fexofenadine hydrochloride tablet optionally suppresses antigen to cause at sensitized guinea pig; Peritoneal mast cells can be suppressed to discharge histamine rat; It does not have anti-parasympathetic nervous physiological action or α * adrenoceptor blocking effect; And fexofenadine hydrochloride does not have sedation and other central nervous system effect.Therefore it is not by blood brain barrier, does not block the potassium channel of animal cardiac muscle cell; Potential the polarizing again of patient's heart function can not be affected, QT interval prolongation can not be made and produce cardiac toxicity.
Fexofenadine hydrochloride is poor solubility in aqueous, is used for showing insoluble problem in the described compound effectively giving patient in preparation.Well-designed preparation at least should can present the hydrophobic compound for the treatment of effective dose to the absorption site expected with absorbable form.When sending hydrophobic therapeutic agent and needing to interact with aqueous physiological environment (as gastric juice and intestinal juice), even above-mentioned MIN functional being all difficult to realizes.In addition, due to the difference of gastrointestinal function and food intake, the drug absorption in Different Individual may be obviously different.Therefore, determine that also control dose is quite difficult.
The unique distinction of fexofenadine hydrochloride is: in vitro in model even in higher dosage, it shows non-sedating completely.Reported outer fluidity transporter P-glycoprotein transport fexofenadine, and it is considered the important decision thing of fexofenadine hydrochloride pharmacokinetics.Since fexofenadine hydrochloride is the substrate of P-gp and some organic anions transhipment polypeptide (OATP), the medicine of food and co-administered has obvious impact by its oral administration biaavailability.In addition another challenge of the fexofenadine hydrochloride preparation of oral delivery form is the low solubility of fexofenadine hydrochloride, the dissolubility (dissolubility is every milliliter of pH1.2 aqueous buffer solution 0.2mg fexofenadine HCl) especially in gastric environment.
Patent documentation CN200910079332.2 discloses a kind of fexofenadine hydrochloride orally disintegrating tablet, containing fexofenadine hydrochloride, compound disintegrating agent, filler, lubricant, compound correctives, it is characterized in that wherein compound disintegrating agent is superdisintegrantes, addition inside and outside superdisintegrantes; Addition inside and outside compound correctives.
Patent documentation CN200810181039.2 discloses a kind of preparation method of fexofenadine hydrochloride orally disintegrating tablet.Based on the advantage of oral cavity disintegration tablet dosage form itself, this product not only solves that the disintegration existing for dosage form of external listing is poor, onset is slow and the shortcoming such as bioavailability is low, but also compensate for the blank of this product in China market, adapt to the growth requirement of Market Situation.
Patent documentation CN201010184558.1 discloses a kind of oral cavity disintegration tablet containing fexofenadine or its salt; this oral cavity disintegration tablet adopts the technology preparation of enclose; when principal agent and clathrate exist with specific ratio; effectively can solve the taste of principal agent and the problem of disintegrate; convenient operation, transport and storage, applied range, applicable large-scale production.
Although above fexofenadine hydrochloride preparation achieves fater disintegration, the technological deficiency existed is that stripping is poor, and bioavailability is poor.
In addition, in combination of oral medication, another problem of fexofenadine hydrochloride preparation is its offending, dense and the taste of hardship and pleasant impression, and it causes, to treatment poor compliance, even not having compliance, and therefore produces passive impact to the effectiveness for the treatment of.
Generally speaking, by pulverizing that to medical compounds there is less particle diameter, contribute to the stripping property improving medicament, but for the solid preparation containing fexofenadine hydrochloride, the particle size distribution of drug microparticles and the not linear change of the bioavailability of medicament.Although prior art teaches the existence of the micronization technology of fexofenadine hydrochloride, but its bioavailability not makes patient satisfaction, is unsuitable for Clinical practice.
For above-mentioned reasons, the absorption improving oral administration medicine is the key point of the low bioavailability concerns solving poorly soluble medicine.
Summary of the invention
Object of the present invention solves the problem exactly, a kind of micronization fexofenadine hydrochloride with appropriate solubility is provided, this micronized fexofenadine hydrochloride all has good dissolution characteristic under multiple pH condition, effectively ensure that medicine can play respective action in different people colony.Meanwhile, present invention also offers containing this micronization fexofenadine hydrochloride is the solid composite medicament of active component.
Another object of the present invention is to provide the preparation method of above-mentioned micronized fexofenadine hydrochloride.
A kind of micronization fexofenadine hydrochloride, its feature is, the particle diameter at 95% cumulative volume place of fexofenadine hydrochloride is below 60 μm.
Above-mentioned micronized fexofenadine hydrochloride, is preferably, the particle diameter at its 95% cumulative volume place is below 30 μm; More preferably be, the particle diameter at its 95% cumulative volume place is below 20 μm.
As the present invention one preferred embodiment, present invention also offers a kind of preparation method of micronization fexofenadine hydrochloride, carry out precomminution by fexofenadine hydrochloride, making particle diameter is 50-100 μm of granule, adopt superfine communication technique to carry out micronization again, making particle diameter is 5-15 μm of fine powder.
As the present invention one preferred embodiment, precomminution adopts the conventional crushing technology in this area to carry out, and described technology comprises, but be not limited to grinding, extruding, collision, cutting, reducing mechanism used includes, but are not limited to mortar, ball mill, fluid energy mill, preferably adopts the fluid energy mill of impacting technology.
As the present invention one preferred embodiment, superfine communication technique is selected from mechanical activation comminution, vibrant pulverization, comminution by gas stream, Ultrasonic Pulverization, high pressure abrasive; Preferred airflow pulverization.Superfine communication technique equipment therefor is selected from QWJ-5 air-flow vortex pulverizer, QWJ-15 air-flow vortex pulverizer, CWM-80 super vortex mill, CWM-120 super vortex mill, CWJ-30 super micron mill, CWJ-45 super micron mill, preferred CWJ-30 type super micron mill.
Preferred, the concrete operation step that described airflow pulverization adopts is as follows: be that coarse grained fexofenadine hydrochloride injects super micron mill jointly with the noble gas after lyophilization by precomminution, high velocity air is adopted to pulverize, preferably, noble gas after lyophilization, preferred air or nitrogen, temperature is 0-15 DEG C, preferably 5 DEG C-10 DEG C, water content≤1%, during air Injection super micron mill, pressure is 0.8-1.5MPa, preferred 1.1-1.2MPa, super micron mill operating pressure is 0.8-1.5MPa, preferred 1.1-1.2MPa, internal operating temperature is 0-8 DEG C, preferably 2 DEG C-6 DEG C, grinding time is 30-200min, preferred 50-150min.
Another object of the present invention is to provide a kind of pharmaceutical composition, be made up of above-mentioned micronized fexofenadine hydrochloride and pharmaceutically acceptable carrier or adjuvant, wherein micronized fexofenadine hydrochloride accounts for the 10%-40% of pharmaceutical composition gross weight, described adjuvant be selected from disintegrating agent, filler, binding agent, wetting agent, lubricant, sweeting agent more than one.
Described pharmaceutically acceptable carrier is extensive use in pharmaceutical techniques field, those skilled in the art can be suitable select, except aforesaid kind, stabilizing agent, emulsifying agent, fluidizer, coating materials etc. can also be comprised, or other carrier that it may occur to persons skilled in the art that or adjuvant.
Another object of the present invention is to provide a kind of containing fexofenadine hydrochloride pharmaceutical composition, and it can be tablet, capsule and granule, preferred tablet.This pharmaceutical composition comprises fexofenadine hydrochloride and suitable adjuvant.
The adjuvant of fexofenadine hydrochloride pharmaceutical composition of the present invention, include but not limited to disintegrating agent, filler, binding agent, wetting agent, lubricant, sweeting agent etc., wherein disintegrating agent is selected from one or more in carboxymethylstach sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose; Filler is selected from one or more in lactose, microcrystalline Cellulose, starch, sucrose, pregelatinized Starch, dicalcium phosphate dihydrate, mannitol, sorbitol; Binding agent is selected from one or more in hypromellose, PVP K30, sodium carboxymethyl cellulose, starch slurry; Wetting agent is selected from ethanol or water; Lubricant is selected from one or more in magnesium stearate, silicon dioxide, Pulvis Talci, sodium lauryl sulphate, sodium stearyl fumarate, PEG6000; Sweeting agent is selected from one or more in Aspartane, steviosin, sucralose, saccharin sodium.
Micronized fexofenadine hydrochloride pharmaceutical composition of the present invention, its preparation method comprises the steps:
(1) be that the fexofenadine hydrochloride of 3-10 μm and disintegrating agent, filler etc. cross 100 mesh sieves, then mix homogeneously respectively by micronized particle diameter;
(2) in the supplementary material powder of mix homogeneously, add binder solution or wetting agent, prepare soft material, cross 20-30 mesh sieve wet granular, 50-70 DEG C of forced air drying 30-90 minute;
(3) dry granule crosses 18 mesh sieve granulate, adds lubricant always mixed 5-15 minute, mix homogeneously;
(4) tabletting, filled capsules or pack, to obtain final product.
As one of preferred embodiment, the present invention's adopt superfine communication technique to prepare compound that particle diameter is the fexofenadine hydrochloride of 5-15 μm, improve the water-soluble of fexofenadine hydrochloride, improve bioavailability, add the clinical efficacy of pharmaceutical preparation.
Another object of the present invention is the pharmaceutical composition providing a kind of micronization fexofenadine hydrochloride, it is characterized in that, the particle diameter at 95% cumulative volume place of wherein said micronization fexofenadine hydrochloride is below 60 μm; The particle diameter at preferably described micronization fexofenadine hydrochloride 95% cumulative volume place is below 30 μm.
Another object of the present invention is to provide the application of the pharmaceutical composition of micronization fexofenadine hydrochloride in the pharmaceutical preparation preparing antihistamine effect.
Micronization fexofenadine hydrochloride of the present invention and compositions thereof have following therapeutic effect:
1. seasonal allergic rhinitis: be applicable to alleviate adult's symptom relevant with the seasonal allergic rhinitis of the child of more than 6 years old and 6 years old.As sneeze, rhinorrhea, nose, maxillary, throat are itched, itching eyes, humidity, rubescent.
2. chronic idiopathic urticaria: the skin symptom being applicable to the chronic idiopathic urticaria for the treatment of adult and more than 6 years old and 6 years old age child, can alleviate the quantity of pruritus and welt.
The general effective dosage ranges that in the per unit medicament of described relevant disease, activate micro powder changes into point fexofenadine hydrochloride is in about between 1-150mg, most preferably be 50-120mg, such as 60mg, described composition solid medicament can be used with single or fractionated dose, is finally to be determined by the doctor participating in treatment.
The preparation method of above-mentioned micronization fexofenadine hydrochloride, the method fexofenadine hydrochloride raw material is passed through pulverizing, grinding, spraying dry or obtained by the method etc. being applicable to sieve.
beneficial effect of the present invention
Present inventor surprisingly finds, only have when the particle diameter at 95% cumulative volume place of fexofenadine hydrochloride is below 60 μm, particularly below 30 μm, when optimum is below 20 μm, with the solid preparation that this micronized fexofenadine hydrochloride is active component, there is excellent dissolution in vitro, under multiple pH condition, all there is good dissolution characteristic, effectively ensure that medicine can play respective action in different people colony, solve existing fexofenadine hydrochloride medicine in vivo gastrointestinal tract environment be subject to the time not easily stripping of other drug or food effect, medicine bioavailability is in vivo caused to reduce and the problem that affects the treatment.
Micronization fexofenadine hydrochloride provided by the invention, the evaluation of its dissolution in vitro evaluates at the dissolution of the medium Chinese medicine of multiple pH value by measuring fexofenadine hydrochloride solid preparation, the mensuration of described dissolution carries out measuring according to the method for testing described in embodiment below, and described assay method is as annex XC first method or the second method are implemented according to Chinese Pharmacopoeia 2010 editions described methods.
Detailed description of the invention
Following examples further illustrate of the present invention, but never limit the scope of the present invention.Elaborate the present invention further referring to embodiment, but it will be appreciated by those skilled in the art that the present invention is not limited to the preparation method of these embodiments and use.And those skilled in the art can carry out equivalent replacement, combination, improvement to the present invention according to description of the invention or modify, but these all will comprise within the scope of the invention.
preparation example 1
Mechanical crusher is used to carry out superfine grinding to fexofenadine hydrochloride raw material, collect the feed particles after pulverizing, use Malvern laser particle analyzer to measure its grain size of micropowder, the particle diameter at 95% cumulative volume place, below 30 μm, obtains micronized fexofenadine hydrochloride.
preparation example 2
Jet mill is used to carry out superfine grinding to fexofenadine hydrochloride raw material, collect the feed particles after pulverizing, use Malvern laser particle analyzer to measure its grain size of micropowder, the particle diameter at 95% cumulative volume place, below 20 μm, obtains micronized fexofenadine hydrochloride.
preparation example 3
(1) adopted by fexofenadine hydrochloride the fluid energy mill of impacting technology to carry out precomminution, making particle diameter is 80 μm of granules,
(2) adopt CWJ-30 type super micron mill to carry out micronizing to above-mentioned coarse granule, be ground into 5-10 μm of fine powder,
Pulverization conditions: the air themperature after lyophilization is 6 DEG C, water content 0.5%, during injection super micron mill, pressure is 0.8MPa, and the operating pressure of super micron mill is 0.8MPa, and internal operating temperature is 6 DEG C, and grinding time is 50min.
embodiment 1
After the micronized fexofenadine hydrochloride 20g of preparation example 1 is mixed homogeneously with microcrystalline Cellulose 20g, lactose 100g, hypromellose 10g, cross-linking sodium carboxymethyl cellulose 5g, after adding suitable amount of adhesive wet granulation, oven dry, granulate, add tabletting after magnesium stearate 2g mix homogeneously, obtained 1000.
embodiment 2
After micronized for preparation example 2 fexofenadine hydrochloride 20g is mixed homogeneously with microcrystalline Cellulose 20g, lactose 100g, hypromellose 10g, cross-linking sodium carboxymethyl cellulose 5g, after adding suitable amount of adhesive wet granulation, oven dry, granulate, add tabletting after magnesium stearate 2g mix homogeneously, obtained 1000.
embodiment 3
After micronized for preparation example 3 fexofenadine hydrochloride 20g is mixed homogeneously with microcrystalline Cellulose 20g, lactose 100g, hypromellose 10g, cross-linking sodium carboxymethyl cellulose 5g, after adding suitable amount of adhesive wet granulation, oven dry, granulate, add tabletting after magnesium stearate 2g mix homogeneously, obtained 1000.
embodiment 4
(1) be that the fexofenadine hydrochloride 30g of less than 20 μm and cross-linking sodium carboxymethyl cellulose 20g, mannitol 50g, microcrystalline Cellulose 120g cross 100 mesh sieves, then mix homogeneously respectively by micronized for preparation example 2 particle diameter;
(2) in the supplementary material powder of mix homogeneously, add 2% hypromellose 50% alcoholic solution and prepare soft material, cross 20 mesh sieve wet granulars, 50 DEG C of forced air dryings 90 minutes;
(3) dry granule crosses 18 mesh sieve granulate, adds lubricant always mixed 5 minutes, mix homogeneously;
(4) tabletting, to obtain final product.
embodiment 5
(1) be that the fexofenadine hydrochloride 30g of 5-10 μm and cross-linking sodium carboxymethyl cellulose 20g, mannitol 50g, microcrystalline Cellulose 120g cross 100 mesh sieves, then mix homogeneously respectively by micronized for preparation example 3 particle diameter;
(2) in the supplementary material powder of mix homogeneously, add 2% hypromellose 50% alcoholic solution and prepare soft material, cross 20 mesh sieve wet granulars, 50 DEG C of forced air dryings 90 minutes;
(3) dry granule crosses 18 mesh sieve granulate, adds lubricant always mixed 5 minutes, mix homogeneously;
(4) tabletting, to obtain final product.
embodiment 6
(1) be that the fexofenadine hydrochloride 60g of 5-10 μm and cross-linking sodium carboxymethyl cellulose 8g, pregelatinized Starch 33g, microcrystalline Cellulose 75g sieve respectively by micronized for preparation example 3 particle diameter, then mix homogeneously;
(2) in the supplementary material powder of mix homogeneously, add polyvidone aqueous solution and prepare soft material, cross sieve series wet granular, dry by specified temp;
(3) dry pellet through sieves granulate, adds magnesium stearate always mixed 5 minutes, mix homogeneously;
(4) tabletting, to obtain final product.
comparative example 1
(1) after fexofenadine hydrochloride (particle diameter: the 120-250 μm) 20g of routine being mixed homogeneously with microcrystalline Cellulose 20g, lactose 100g, hypromellose 10g, cross-linking sodium carboxymethyl cellulose 5g, after adding suitable amount of adhesive wet granulation, oven dry, granulate, add tabletting after magnesium stearate 2g mix homogeneously, obtained 1000.
comparative example 2
(1) fexofenadine hydrochloride (particle diameter: the 120-250 μm) 30g and cross-linking sodium carboxymethyl cellulose 20g of routine, mannitol 50g, microcrystalline Cellulose 120g are crossed 100 mesh sieves, then mix homogeneously respectively;
(2) in the supplementary material powder of mix homogeneously, add 2% hypromellose 50% alcoholic solution and prepare soft material, cross 20 mesh sieve wet granulars, 50 DEG C of forced air dryings 90 minutes;
(3) dry granule crosses 18 mesh sieve granulate, adds lubricant always mixed 5 minutes, mix homogeneously;
(4) tabletting, to obtain final product.
the dissolution of test example 1 determination experiment example 1-5 and comparative example 1-2
Get the tablet of above-described embodiment 1-5, comparative example 1-2, test according to dissolution method (Chinese Pharmacopoeia version in 2010 two annex XC first methods), respectively with the buffer 900ml of 3 kinds of different pH value for dissolution medium, speed setting is 50 turns per minute, operate in accordance with the law, sampling and measuring through 45 minutes time, the dissolution of 45 minutes sees the following form 1 and table 2.
Table 1
| Sample | PH1.0 | PH5.0 | PH6.8 |
| Embodiment 1 | 91.0％ | 87.3％ | 85.5％ |
| Embodiment 2 | 93.3％ | 91.5％ | 88.3％ |
| Embodiment 3 | 99.8％ | 93.3％ | 90.7％ |
| Comparative example 1 | 73.0％ | 67.3％ | 61.2％ |
Result: embodiment 3 is better than embodiment 2 and is better than embodiment 1 and is better than comparative example 1, the preparation that the preparation that the fexofenadine hydrochloride that visible the present invention has specified particle diameter distribution is formed adopts the fexofenadine hydrochloride of conventional particle size distribution to prepare compared with prior art has better stripping; More crucially, the stripping of preparation prepared by the fexofenadine hydrochloride obtained by separating twice described in embodiment 3 is better.
Table 2
| Sample | PH1.0 | PH5.0 | PH6.8 |
| Embodiment 4 | 94.5％ | 92.2％ | 90.9％ |
| Embodiment 5 | 99.9％ | 95.4％ | 92.7％ |
| Comparative example 2 | 71.4％ | 68.3％ | 63.5％ |
Result: embodiment 5 is better than embodiment 4 and is better than comparative example 2, the preparation that the preparation that the fexofenadine hydrochloride that visible the present invention has specified particle diameter distribution is formed adopts the fexofenadine hydrochloride of conventional particle size distribution to prepare compared with prior art has better stripping; More crucially, the stripping of preparation prepared by the fexofenadine hydrochloride obtained by separating twice described in embodiment 5 is better.
test example 2 measures the dissolubility of the fexofenadine hydrochloride of different-grain diameter
According to preparation example 1-3, preparation has the fexofenadine hydrochloride of specified particle diameter, makes supersaturated solution, and calculate the dissolubility of fexofenadine hydrochloride in water by detection level, result is as follows:
Conclusion: from above test data, the dissolubility of fexofenadine hydrochloride reduces along with the increase of particle diameter.
test example 3 measures the bioavailability of the fexofenadine hydrochloride of different-grain diameter
According to the preparation method of embodiment 1-5 and comparative example 1-2, the fexofenadine hydrochloride of specified particle diameter and conventional particle size is adopted to prepare corresponding preparation respectively, then oral rear by detecting blood drug level, judge its bioavailability result:
* the bioavailability of comparative example 1 and comparative example 2 is respectively 35% and 38%.
Conclusion: known by above-mentioned data, preparation bioavailability prepared by the fexofenadine hydrochloride of particle diameter 5-10 μm is best, next is the fexofenadine hydrochloride that 95% particle diameter is less than 20 μm, preparation bioavailability prepared by the fexofenadine hydrochloride of particle size < 5 μm again, then be the preparation bioavailability that particle diameter is less than the fexofenadine hydrochloride of 30 μm, and be much higher than the preparation of the conventional particle size fexofenadine hydrochloride of comparative example 1 and 2; So the fexofenadine hydrochloride selecting particle diameter 5-10 μm or 95% particle diameter to be less than 20 μm both ensure that bioavailability, made again production technology feasible, absolutely proved benefit of the present invention and innovation.
Claims (5)
1. the pharmaceutical composition of a micronization fexofenadine hydrochloride, it is characterized in that, be made up of micronized fexofenadine hydrochloride and pharmaceutically acceptable adjuvant, the particle diameter at 95% cumulative volume place of wherein said micronization fexofenadine hydrochloride is below 20 μm, micronization fexofenadine hydrochloride accounts for the 10%-40% of pharmaceutical composition gross weight, described adjuvant, be selected from disintegrating agent, filler, binding agent, wetting agent, lubricant, sweeting agent more than one.
2. pharmaceutical composition according to claim 1, is characterized in that, this pharmaceutical composition is tablet.
3. the preparation method of the medicinal composition tablets containing micronized fexofenadine hydrochloride as claimed in claim 2, it comprises the steps:
(1) be that the fexofenadine hydrochloride of 3-10 μm and disintegrating agent, filler cross 100 mesh sieves, then mix homogeneously respectively by micronized particle diameter,
(2) in the supplementary material powder of mix homogeneously, add binder solution or wetting agent, prepare soft material, cross 20-30 mesh sieve wet granular, 50-70 DEG C of forced air drying 30-90 minute,
(3) dry granule crosses 18 mesh sieve granulate, adds lubricant always mixed 5-15 minute, mix homogeneously,
(4) tabletting, to obtain final product.
4. a micronization fexofenadine hydrochloride, it is characterized in that, the particle diameter at 95% cumulative volume place of fexofenadine hydrochloride is below 20 μm, its preparation method is, fexofenadine hydrochloride is carried out precomminution, making particle diameter is 50-100 μm of granule, then adopts superfine communication technique to carry out micronization, and making particle diameter is 5-15 μm of fine powder.
5. the application of pharmaceutical composition according to claim 1 in the pharmaceutical preparation preparing antihistamine effect.
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