CN109925289B - Desloratadine dispersible tablet - Google Patents
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Abstract
The invention provides a desloratadine dispersible tablet which consists of an internal addition granulation and an external addition material, wherein the internal addition granulation comprises desloratadine and solid acid which are mixed in a melting way, and the external addition material comprises pectin.
Description
Technical Field
The invention belongs to the field of antiallergic drugs and medicaments, and particularly provides a desloratadine dispersible tablet which consists of an internal addition granulation and an external material, wherein the internal addition granulation comprises desloratadine and solid acid which are melt-mixed, and the external material comprises pectin.
Background
Loratadine (Loratadine), chemical name 4- (8-chloro-5, 6-dihydro-11H-benzo [5,6 ]]-cyclohepta [1,2-b ]]Pyridin-11-enyl) -1-piperidinecarboxylic acid ethyl ester of formula C22H23ClN2O2The loratadine hydrochloride has the advantages of high molecular weight of 382.89, white or nearly white crystalline powder in appearance, no odor, melting point of 133-137 ℃, almost no solubility in water, slight solubility in hydrochloric acid solution, easy solubility in organic solvents such as ethanol, methanol, acetone and the like, and an active metabolite of the loratadine in vivo is desloratadine.
Loratadine belongs to a second-generation histamine H1-receptor antagonist, has a selective effect on peripheral receptors, and is clinically commonly used for the treatment of allergic dermatitis, allergic conjunctivitis, allergic rhinitis, pollinosis, urticaria and the like. The loratadine overcomes the lethargy caused by the central nervous inhibition of the first generation of antihistamines, and has the characteristics of high curative effect, quick response, strong action, no tolerance and no obvious adverse reaction. Currently, loratadine dosage forms on the market at home comprise enteric-coated tablets, orally disintegrating tablets, syrup, suspension, capsules and the like. Because the dissolving performance of loratadine, especially the dissolving performance in non-strong acid solution is not good, the loratadine in various dosage forms is mainly designed for improving the dissolution performance and the bioavailability thereof. Loratadine tablets are already on the market in several varieties, and their improvement is still directed to further improvements in their bioavailability, particularly in patients with gastric insufficiency.
Disclosure of Invention
In order to solve the problems, the applicant tries to melt and mix desloratadine and a suitable solid acid to prepare a suitable acid environment for dissolving/dissolving the desloratadine, and adds a proper amount of pectin and corn starch in an additive material to increase the viscosity of a medicine-containing part by matching with dissolved malic acid and even form a local micro jelly-like substance so as to improve the retention time of the medicine in the digestive tract, and finally realizes the effect of improving the dissolving/dissolving of the desloratadine and further improving the bioavailability of the desloratadine. By using the principle, the applicant invents an internal granulation method comprising melt mixing desloratadine and solid acid and corresponding desloratadine dispersible tablets with high bioavailability.
In one aspect, the present application provides a desloratadine dispersible tablet consisting of an internal granulation comprising melt-mixed desloratadine and a solid acid, and an external material.
Further, the solid acid is malic acid.
Further, the internal addition granulation comprises desloratadine and solid acid, calcium hydrophosphate and corn starch which are melt-mixed, and a purified water solvent is used for preparing the internal addition granulation, and the weight ratio of the desloratadine to the solid acid in the melt-mixed desloratadine and solid acid is 1: 0.5-2.
Further, 4.55% by weight of desloratadine and solid acid, 48.18% by weight of calcium hydrogen phosphate and 1.36% by weight of corn starch are melt-mixed, and the weight ratio of desloratadine to solid acid in the melt-mixed desloratadine and solid acid is 1: 1.
Further, the additional materials comprise microcrystalline cellulose, pectin, talcum powder, corn starch, sodium carboxymethyl starch and magnesium stearate.
Further, the desloratadine dispersible tablet is internally granulated by weight and comprises desloratadine and solid acid which are mixed in a melting way, 4.55%, calcium hydrophosphate 48.18% and corn starch which are mixed in a melting way, and the additional materials comprise 36.20% of microcrystalline cellulose, 3.55% of pectin, 2.73% of talcum powder, 1.82% of corn starch, 0.91% of carboxymethyl starch sodium and 0.70% of magnesium stearate.
On the other hand, the application provides a preparation method of the desloratadine orally disintegrating tablet, which comprises the step of melt mixing desloratadine and solid acid at the temperature of 130-155 ℃ for 5-15 minutes.
Further, the preparation method of the desloratadine orally disintegrating tablet comprises the following steps:
(1) weighing the required amount of various components, sieving desloratadine with a 100-mesh sieve, sieving calcium hydrophosphate with a 200-mesh sieve, and sieving talcum powder with a 1250-mesh sieve;
(2) after uniformly mixing desloratadine and malic acid, heating to be molten at 155 ℃, and maintaining the molten state for 5 minutes;
(3) dispersing corn starch slightly more than the theoretical amount in cold water, stirring, starting timing when the temperature of an aqueous solution reaches 70 ℃, continuously stirring for more than 30 minutes, supplementing lost water after pulp boiling is finished, and reserving after the temperature is reduced to 75-80 ℃, wherein the solid content of the corn starch is 8.0%;
(3) putting calcium hydrogen phosphate, desloratadine and malic acid which are mixed in a melting mode into a wet granulation pot, stirring at 60rpm, cutting at 1500rpm, stopping the wet granulation pot after running for 5 minutes, adjusting the air pressure of a liquid adding tank to be 0.4Mpa, adding the corn starch slurry in a slurry spraying mode after the pipeline is full of the corn starch slurry, stopping the wet granulation pot after running for 8 minutes, and finishing wet granules by a granulator with the particle size of 8 multiplied by 8 mm;
(4) setting the air inlet temperature to be 70 ℃ and the material temperature to be 60 ℃, starting sampling when the material temperature reaches 40 ℃, detecting the drying weight loss of the material treated at 105 ℃ for 10 minutes, and stopping drying when the drying weight loss is less than or equal to 3.0%;
(5) the dry particles are granulated by a screen with the aperture of 0.65mm, and the set rotating speed is 470-530 rpm;
(6) premixing dry granules, microcrystalline cellulose, pectin, talcum powder, corn starch and sodium carboxymethyl starch, setting the rotating speed to be 10rpm, operating for 20 minutes, adding magnesium stearate, operating for 5 minutes, stopping the machine, and discharging;
(7) and (6) tabletting.
In another aspect, the present application provides a use of fine drug-containing particles in the preparation of a medicament for treating urticaria, pruritic skin diseases, allergic rhinitis, the fine drug-containing particles comprising 8.4% of desloratadine and solid acid, 89.1% of calcium hydrogen phosphate, and 2.5% of corn starch, wherein the weight ratio of desloratadine to solid acid in the desloratadine and solid acid is 1:1, and the fine drug-containing particles are prepared by using a purified aqueous solvent.
The desloratadine dispersible tablets/drug-containing particles can be used for treating various known/to-be-discovered diseases of the loratadine/desloratadine, such as urticaria, pruritic skin diseases, allergic rhinitis or preparing medicines for treating the diseases.
The components and solvents other than desloratadine, solid acid and pectin in the desloratadine dispersible tablet of the present application, including but not limited to microcrystalline cellulose, pectin, talc powder, corn starch, sodium carboxymethyl starch, magnesium stearate, calcium hydrogen phosphate, corn starch and purified water, can be replaced by other excipients or solvents with similar properties according to the common knowledge and simple experiment of the skilled person in the pharmaceutical field, and various excipients and solvents can be selected from the commercial products of various manufacturers or the products prepared by the manufacturers.
Besides orally disintegrating tablets, the drug-containing particles of the application can also be used for preparing other desloratadine dosage forms, including but not limited to oral preparations such as dispersible tablets, enteric-coated tablets, dry suspensions, suspensions and syrups, and external preparations such as sprays, film coatings, creams, ointments and patches.
Detailed Description
The main reagents are as follows:
desloratadine: hainanpril pharmaceutical products, Inc.;
malic acid: anhui mountain river pharmaceutic adjuvant, Inc.;
microcrystalline cellulose, pectin, talc, corn starch, sodium starch glycolate, magnesium stearate, calcium hydrogen phosphate, corn starch: produced by Anhui mountain river pharmaceutic adjuvant corporation, Lianchong DuPont Fine chemical corporation, Huzhou expedition pharmaceutical corporation, Guangxi Longshenghua talc development corporation, JRS, etc.
Example 1 preparation of dispersible tablets of desloratadine.
Formulation 1
Internal granulation: melt-mixed desloratadine and malic acid 4.55% (weight ratio of desloratadine to malic acid 1:1), calcium hydrogen phosphate 48.18%, corn starch 1.36%
Adding materials: 36.20 percent of microcrystalline cellulose, 3.55 percent of pectin, 2.73 percent of talcum powder, 1.82 percent of corn starch, 0.91 percent of sodium carboxymethyl starch and 0.70 percent of magnesium stearate.
Formulation 2
Internal granulation: melt-mixed desloratadine and malic acid 4.55% (weight ratio of desloratadine to malic acid 1:1), calcium hydrogen phosphate 48.18%, corn starch 1.36%
Adding materials: 39.75% of microcrystalline cellulose, 2.73% of talcum powder, 1.82% of corn starch, 0.91% of carboxymethyl starch sodium and 0.70% of magnesium stearate.
Comparative formulation
Internal granulation: 7.45 percent of desloratadine, 48.18 percent of calcium hydrophosphate and 1.36 percent of corn starch
Adding materials: 39.75 percent of microcrystalline cellulose, 4.63 percent of talcum powder, 2.82 percent of corn starch, 0.91 percent of carboxymethyl starch sodium and 0.70 percent of magnesium stearate.
The preparation process comprises the following steps:
(1) weighing the required amount of various components, sieving desloratadine with a 100-mesh sieve, sieving calcium hydrophosphate with a 200-mesh sieve, and sieving talcum powder with a 1250-mesh sieve;
(2) after uniformly mixing desloratadine and malic acid, heating to be molten at 155 ℃, and maintaining the molten state for 5 minutes (formulas 1 and 2)/no-melt mixing step (comparative formula);
(3) dispersing corn starch slightly more than the theoretical amount in cold water, stirring, starting timing when the temperature of an aqueous solution reaches 70 ℃, continuously stirring for more than 30 minutes, supplementing lost water after pulp boiling is finished, and reserving after the temperature is reduced to 75-80 ℃, wherein the solid content of the corn starch is 8.0%;
(3) putting calcium hydrogen phosphate, desloratadine and malic acid which are mixed in a melting mode into a wet granulation pot, stirring at 60rpm, cutting at 1500rpm, stopping the wet granulation pot after running for 5 minutes, adjusting the air pressure of a liquid adding tank to be 0.4Mpa, adding the corn starch slurry in a slurry spraying mode after the pipeline is full of the corn starch slurry, stopping the wet granulation pot after running for 8 minutes, and finishing wet granules by a granulator with the particle size of 8 multiplied by 8 mm;
(4) setting the air inlet temperature to be 70 ℃ and the material temperature to be 60 ℃, starting sampling when the material temperature reaches 40 ℃, detecting the drying weight loss of the material treated at 105 ℃ for 10 minutes, and stopping drying when the drying weight loss is less than or equal to 3.0%;
(5) the dry particles are granulated by a screen with the aperture of 0.65mm, and the set rotating speed is 470-530 rpm;
(6) premixing dry granules, microcrystalline cellulose, pectin, talcum powder, corn starch and sodium carboxymethyl starch, setting the rotating speed to be 10rpm, operating for 20 minutes, adding magnesium stearate, operating for 5 minutes, stopping the machine, and discharging;
(7) and (6) tabletting.
The dispersible tablets prepared contain 5 mg of desloratadine.
The rotary tablet press used in the preparation was manufactured by Guangzhou gold mechanical equipment, Inc., YC-9; (ii) a The mixer is manufactured by Sichuan Teng Dry engineering Co., Ltd, Changzhou, SYH-1000; wet granulators (not designated as a special model) were manufactured by Nanjing Ruiban pharmaceutical Equipment, Inc.
EXAMPLE 2 stability of Desloratadine dispersible tablets
High temperature conditions: placing the mixture in a constant temperature box at 60 ℃;
high humidity conditions: placing at 25 ℃ and 90% humidity;
strong light condition: under the illumination condition of 5000Lx
Content determination: referring to the second part of the 2010 edition of the chinese pharmacopoeia, appendix VD and HPLC methods of the "study of bioavailability of desloratadine" section: using an Agilent 1100 high performance liquid chromatography system, an Agilent C18 column (4.6mm × 150mm, 5 μm); the mobile phase is acetonitrile: 20 mmol/l ammonium acetate buffer: 1% formic acid 80: 20: 3, the flow rate is 0.5 ml/min, the column temperature is 20 ℃, and the detection wavelength is 247 nm.
Desloratadine dissolution experiments were performed with reference to the chinese pharmacopoeia (method of XC, second part, 2010 version): taking 5 ml of solution (supplementing the same amount of dissolution medium) at 5, 10, 15 and 30 minutes after 50 rpm of dissolution medium of 500 ml, filtering, and taking filtrate for HPLC detection; weighing a proper amount of desloratadine reference substance which is dried to constant weight, adding a dissolving medium to dissolve and quantitatively diluting the desloratadine reference substance into a solution containing 10 micrograms/milliliter of the desloratadine as the reference substance. The dissolution instrument is produced by Tianjin Tianda Tiandai science and technology development Limited company.
The results are shown in the following table:
*the appearance was a white-like tablet appearance with no visible speckles or abnormalities.
Experiments show that the dispersible tablets of the formulas 1 and 2 and the comparative formula can still meet the requirement that the sum of impurities in pharmacopeia is less than or equal to 1.0 percent after being subjected to high-temperature, high-humidity and high-light conditions for 15 days, and the dissolution performance is not obviously changed. After further long-term storage experiments and accelerated aging experiments, the method can be used for actual production.
Example 2 high pH dissolution test of Desloratadine dispersible tablets
The HPLC method, the dissolution determination method and the instrument are the same as the stability of the desloratadine dispersible tablets, and the average value is obtained in three experiments.
The dissolution test results are shown in the following table:
dissolution effect in PBS buffer solution of pH 4.5
| Sample (I) | 5 minutes (%) | 10 minutes (%) | 20 minutes (%) | 30 minutes (%) |
| Formulation 1 | 94.9 | 96.3 | 99.7 | 100.1 |
| Formulation 2 | 94.7 | 95.9 | 99.5 | 100.3 |
| Comparative formulation | 60.2 | 65.7 | 70.5 | 72.9 |
Dissolution effect in purified water of pH 6.7
| Sample (I) | 5 minutes (%) | 10 minutes (%) | 20 minutes (%) | 30 minutes (%) |
| Formulation 1 | 60.9 | 67.2 | 74.8 | 90.1 |
| Formulation 2 | 59.3 | 65.2 | 71.0 | 86.5 |
| Comparative formulation | 38.2 | 44.4 | 54.7 | 61.3 |
The data show that the dissolution performance of the formulas 1 and 2 is obviously better than that of the comparative formula at high pH, particularly the dissolution performance in a buffer solution with pH 4.5 basically reaches the dissolution capacity (basically complete dissolution in 10 minutes) of a common loratadine tablet in artificial gastric juice with pH2 reported in the literature, and the dissolution performance is also obviously better than that of the comparative formula in purified water. The acid environment created by melt mixing the desloratadine and the proper fixed acid can obviously improve the dissolving/dissolving effect of the desloratadine. In addition, trace amounts of jelly/floc debris were visible at the edge of the instrument during dissolution testing of formulation 1, which was more pronounced in purified water.
EXAMPLE 3 bioavailability study of Desloratadine dispersible tablets
According to the literature (xujie et al, "HPLC fluorimetric assay and bioequivalence study of plasma concentrations of loratadine", pharmaceutical press, 2004, vol.39, phase 2 and literature cited therein) and the applicant's researchers' practice, preliminary studies of small sample volumes of pharmacokinetics and bioavailability are not suitable for statistical methods due to the differences in the P450 enzyme system, the pharmacokinetic profile and bioavailability of loratadine vary greatly from individual to individual. The applicant, in studying the pharmacokinetic profile and bioavailability of the loratadine dosage forms of the present application in comparison with other similar dosage forms, used a comparison in the same volunteers. Bioequivalence experiments with larger sample sizes were in the tissue after formulation was determined.
Test subject
3 volunteer subjects (2 men, age 26, 28 years, weight 69.9kg, 76.1 kg; 1 woman, age 27 years, weight 62.1kg) were recruited. The normal functions of the heart, the liver and the lung, the normal biochemical indexes of the main related blood and no major diseases or medical history are confirmed by the subject through routine physical examination. No other medicines are used in the 1 month before the test, no medicines and health products are used during the test period, and the smoking and the drinking are forbidden.
Experimental protocol
After fasting for 12 hours, the subjects took 2 tablets (10 mg of active ingredient) of desloratadine dispersible tablet of formulation 1 of the present application earlier between 7:00 and 8: 00. Pre-dose and post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5,6, 8, 12, 24, 36 hours of forearm venous blood 3mL was placed in an anticoagulated blood collection tube, centrifuged 3000 minutes to separate plasma for 15 minutes and stored in a freezer at-20 ℃ as an analytical sample.
After the last blood draw, the subjects had a 10 day drug removal period and after a further 12 hour fast, had been given 2 tablets (10 mg of active ingredient) of desloratadine dispersible tablets of formula 2(1 example) of the present application and comparative formula (2 examples) between 7:00 and 8:00 early. Pre-dose and post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5,6, 8, 12, 24, 36 hours of forearm venous blood 3mL was placed in an anticoagulated blood collection tube, centrifuged 3000 minutes to separate plasma for 15 minutes and stored in a freezer at-20 ℃ as an analytical sample.
If the subject had a disease or drug use during the drug washout period, the subject's experiment was terminated and the results were not taken (4 subjects, one of whom had not completed the experiment due to the common cold, data not included in the protocol).
Sample processing
During analysis, 0.5 ml of plasma is sucked and added into a test tube, 20 microliters of clozapine internal standard solution of 1.25 micrograms/ml is added and mixed evenly. Adding 3ml of ether, mixing uniformly, centrifuging for 5000-10 minutes, taking an ether layer, drying in a vacuum drying oven until the ether layer is dry, adding 0.2 ml of mobile phase dissolving residue, mixing uniformly, centrifuging for 4000-15 minutes, and taking 50 microliters of supernatant for subsequent liquid chromatography-mass spectrometry analysis.
Liquid chromatography-mass spectrometry analysis blood concentration and data processing
An Agilent 1100 high performance liquid chromatograph system, Agilent LC/MSD Trap XCT mass spectrometer was used.
A chromatographic column: agilent C18 column (4.6mm × 150mm, 5 μm); the mobile phase is acetonitrile: 20 mmol/l ammonium acetate buffer: 1% formic acid 80: 20: 3, flow rate 0.5 ml/min, column temperature 20 ℃.
Mass spectrum: ESI ion source, mass spectrometry conditions: positive ionization (clozapine 327 → 270, desloratadine 311 → 259), capillary voltage 4000 kv, atomizing gas pressure 30 psi, drying gas temperature 350 degrees celsius, drying gas flow 8 liters/min.
The obtained blood drug concentrations were fitted to the biventricular model using PKS program and pharmacokinetic parameters were calculated, AUC was calculated using the trapezoidal method.
Results of the experiment
Preliminary results indicate that the bioavailability of the formulation 1 of the present application is significantly better than that of the comparative formulation (AUC values close to 2 times), and also significantly higher than that of the formulation 2(AUC values close to 1.3 times) under similar dissolution performance. In combination with the phenomena observed in the dissolution test, the dissolved malic acid reacts with pectin and corn starch to increase the viscosity of the drug-containing part and even form local micro-jelly to improve the retention time of the drug in the digestive tract, and finally the bioavailability of the desloratadine is improved.
Claims (2)
1. A desloratadine dispersible tablet, which consists of an internal addition granulation and an external addition material, wherein the internal addition granulation comprises desloratadine and solid acid which are mixed in a melting way, wherein the solid acid is 4.55 percent, the calcium hydrophosphate is 48.18 percent, and the corn starch is 1.36 percent, and the internal addition granulation is prepared by using a purified water solvent; the solid acid is malic acid; the weight ratio of desloratadine to solid acid in the melt-mixed desloratadine and solid acid is 1: 1; the preparation method of the melt-mixed desloratadine and the solid acid comprises the steps of melt-mixing the desloratadine and the solid acid for 5-15 minutes at 155 ℃; the additional materials comprise 36.20 percent of microcrystalline cellulose, 3.55 percent of pectin, 2.73 percent of talcum powder, 1.82 percent of corn starch, 0.91 percent of sodium carboxymethyl starch and 0.70 percent of magnesium stearate;
the percentage is calculated by the total weight of the desloratadine dispersible tablets.
2. A desloratadine dispersible tablet according to claim 1 characterized in that the desloratadine dispersible tablet is prepared by a process comprising:
(1) weighing the required amount of various components, sieving desloratadine with a 100-mesh sieve, sieving calcium hydrophosphate with a 200-mesh sieve, and sieving talcum powder with a 1250-mesh sieve;
(2) after uniformly mixing desloratadine and malic acid, heating to be molten at 155 ℃, and maintaining the molten state for 5 minutes;
(3) dispersing corn starch in cold water, stirring, starting timing when the temperature of an aqueous solution reaches 70 ℃, continuously stirring for more than 30 minutes, supplementing lost water after pulp boiling is finished, and reserving after the temperature is reduced to 75-80 ℃, wherein the solid content of the corn starch is 8.0%;
(4) putting calcium hydrogen phosphate, desloratadine and malic acid which are mixed in a melting mode into a wet granulation pot, stirring at 60rpm, cutting at 1500rpm, stopping the wet granulation pot after running for 5 minutes, adjusting the air pressure of a liquid adding tank to be 0.4Mpa, adding the corn starch slurry in a slurry spraying mode after the pipeline is full of the corn starch slurry, stopping the wet granulation pot after running for 8 minutes, and finishing wet granules by a granulator with the particle size of 8 multiplied by 8 mm;
(5) setting the air inlet temperature to be 70 ℃ and the material temperature to be 60 ℃, starting sampling when the material temperature reaches 40 ℃, detecting the drying weight loss of the material treated at 105 ℃ for 10 minutes, and stopping drying when the drying weight loss is less than or equal to 3.0%;
(6) the dry particles are granulated by a screen with the aperture of 0.65mm, and the set rotating speed is 470-530 rpm;
(7) premixing dry granules, microcrystalline cellulose, pectin, talcum powder, corn starch and sodium carboxymethyl starch, setting the rotating speed to be 10rpm, operating for 20 minutes, adding magnesium stearate, operating for 5 minutes, stopping the machine, and discharging;
(8) and (6) tabletting.
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