CN103877047A - Oxycodone hydrochloride dispersible tablet and preparation method thereof - Google Patents
Oxycodone hydrochloride dispersible tablet and preparation method thereof Download PDFInfo
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- CN103877047A CN103877047A CN201410114111.5A CN201410114111A CN103877047A CN 103877047 A CN103877047 A CN 103877047A CN 201410114111 A CN201410114111 A CN 201410114111A CN 103877047 A CN103877047 A CN 103877047A
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- oxycodone hydrochloride
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Abstract
The invention relates to an oxycodone hydrochloride dispersible tablet and a preparation method thereof, and belongs to the technical field of medicines. The oxycodone hydrochloride dispersible tablet comprises the following components in percentage by weight: 1-5 percent of oxycodone hydrochloride, 50-95 percent of disintegrating agent, 1-10 percent of lubricant and glidant and 1-10 percent of adhesive. The preparation method comprises the following steps: screening the components; uniformly mixing the oxycodone hydrochloride and the disintegrating agent; adding the adhesive to prepare a soft material; granulating, baking and straightening granulating; adding the disintegrating agent, the lubricant and the glidant, and uniformly mixing; determining tablet weight, and tabletting to obtain the oxycodone hydrochloride dispersible tablet. The medicine has stable quality, is beneficial to drug dissolution and absorption, is quick in response and convenient to take, can be taken orally after being dispersed with water, and also can be sucked in the mouth or swallowed.
Description
Invention field
The present invention relates to chemical pharmacy field, be specifically related to surgery anesthesia medication, for the pharmaceutical preparation of reduction of patient pain, i.e. a kind of oxycodone hydrochloride dispersible tablet and preparation method thereof.
Background of invention
Oxycodone hydrochloride is that one contains opioid compounds, and molecular weight is 351.83, and its chemistry is by name: 4,5-epoxy radicals-14-hydroxy-3-methoxy-17-methylmorphine alkane-6-keto hydrochloride.The crystalline powder that white is tasteless.
It is the semi-synthetic analgesic of potent opiates by the exploitation of Lehigh Valley Technologies company of the U.S. that hydrochloric acid is gently examined ketone (oxycodone hydrochloride), on October 20th, 2010 by the new drug approval of U.S. FDA, for alleviating the lasting moderate of human body to severe pain.Oxycodone hydrochloride belongs to the semi-synthetic derivant of morphine, its Analgesic Mechanism is more special, not only act on the μ _ opiate receptor in central nervous system, under some condition, can also act on K-opiate receptor, this medicine is weaker than morphine and methadone to the affinity of μ-opiate receptor in vivo, but its active metabolite oxymophone has stronger affinity to μ-opiate receptor.An alleviation for tumor patient myalgia is tested and is shown, total analgesic effect that oxymophone produces is 7-8 times of morphine, and peak value analgesic effect is 13 times of morphine.In addition,, compared with morphine, oxycodone hydrochloride also has higher oral administration biaavailability.
Oxycodone hydrochloride is as a generic drugs thing, now existing many pharmacy corporations, with different trade names and dosage form listing, are classified as II class controlled drug (schedule II controlled substance) because it has potential abuse risk by U.S. DEA and FDA.Euro-Celtique company of Luxembourg obtains United States Patent (USP) mandate (US5508042) on April 16th, 1996, for the protection of composition and the preparation method of OxyContin.The people such as the McGinity JW in the Austin of Texas university branch school for the non-film controlled release preparation of one of oxycodone hydrochloride, 3 obtain United States Patent (USP) mandate (us6488963) in December in 2002 by hot melt extruded legal system.Purdue Pharma company of the U.S. obtains United States Patent (USP) mandate (US7674799, US7674800, US7683072) respectively on March 9th, 2010 and 23 days, and composition and the preparation method etc. of synthesis technique, its slow releasing tablet and the capsule of these three patents to oxycodone hydrochloride have been carried out corresponding protection.In addition, in order to prevent that medicine from being abused, a kind of Tablet and Capsula agent that can prevent from artificially extracting oxycodone hydrochloride composition has been invented by German Grunenthal Gm bH company, and obtains United States Patent (USP) mandate (US7776314) on August 17th, 2010.
The oxycodone hydrochloride oral formulations that utilizes prior art to obtain, domestic production have a plain pharmacy conventional tablet of Beijing China, import medicine has slow releasing tablet and two of the controlled release tablets that Beijing Meng Di pharmaceutical Co. Ltd produces to produce official written replies.And in clinical practice, patient tends to use the import drugs of Beijing Meng Di pharmaceutical Co. Ltd subpackage, account for the market share approximately more than 90%, import drug price is high, increase patient's financial burden, and domestic dosage form of the same race has almost identical result of use.Meanwhile, due to reasons such as technologies of preparing, Tablet and Capsula agent exists after taking that dissolve scattered time limit is long, dissolution is low, it is poor to absorb, liver sausage first pass effect and the problem such as bioavailability is lower, thereby affects the performance of drug effect, also directly affects the effect for the treatment of.
Through clinical verification for many years, oxycodone hydrochloride is mainly used in reduction of patient pain, and for anesthesia in operating room medication, effect is remarkable.As capsule and the tablet of oral formulations, because it is taken and carry for convenience of more welcome by consumers in general.But the oral formulations of listing is oxycodone hydrochloride conventional tablet, slow releasing tablet and controlled release tablet at present, in 40 minutes, just disintegrate is complete, and slow releasing tablet and controlled release tablet are more of a specified duration, is unfavorable for that drug-eluting absorbs, thus onset immediately.
The invention provides a kind of new oxycodone hydrochloride dispersible tablet, stable and controllable for quality, disintegration rate is fast, and bioavailability is high, rapid-action, and production technology is simple.
Summary of the invention
The invention provides a kind of new oxycodone hydrochloride dispersible tablet and preparation method thereof, be mainly used in analgesia, and for surgery anesthesia medication, processing technology is simple, the quality of the pharmaceutical preparations is reliable and stable.
On the one hand, the invention provides a kind of oxycodone hydrochloride dispersible tablet, the component that it comprises following percentage by weight:
Oxycodone hydrochloride 1～5%
Disintegrating agent 50～95%
Lubricant and fluidizer 1～10%
Binding agent 1～10%.
Some embodiments therein, oxycodone hydrochloride dispersible tablet of the present invention, wherein, described disintegrating agent is one or more in starch, modified starch, cellulose powder, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, alginic acid, kaolin, veegum, silica sol.
Some embodiments therein, oxycodone hydrochloride dispersible tablet of the present invention, wherein, described lubricant and fluidizer are one or more in stearic acid, magnesium stearate, zinc stearate, calcium stearate, hard paraffin, hydrogenated vegetable oil, politef, Polyethylene Glycol, sodium benzoate, sodium laurylsulfate, glyceryl monostearate, monopalmitin, spermol, silicon dioxide, micropowder silica gel, Pulvis Talci, hydrated sodium aluminosilicate.
Some embodiments therein, oxycodone hydrochloride dispersible tablet of the present invention, wherein, described binding agent is one or more in hypromellose, starch slurry, dextrin, syrup, maltose, gelatine size, polyvinylpyrrolidone, Polyethylene Glycol, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, mucialga of arabic gummy.
Some embodiments therein, oxycodone hydrochloride dispersible tablet of the present invention, the component that it comprises following percentage by weight:
Make 1000.
On the other hand, the present invention relates to a kind of preparation method of oxycodone hydrochloride dispersible tablet of the present invention, it comprises following steps:
(1) oxycodone hydrochloride, adjuvant are crossed respectively to 100 mesh sieves, for subsequent use;
(2) take disintegrating agent by recipe quantity, add the oxycodone hydrochloride of recipe quantity, mix homogeneously;
(3) add binding agent to be mixed and made into soft material, granulate with 18-24 mesh sieve, granule is dried under 50-80 DEG C of condition;
(4) after granule is dried, 20 mesh sieve granulate;
(5) add disintegrating agent, lubricant and fluidizer to mix;
(6) sample examination, in mensuration granule, the content of oxycodone hydrochloride, determines sheet weight, tabletting, obtains oxycodone hydrochloride dispersible tablet.
Excipient of the present invention comprises, but be not limited to, ion-exchanger, aluminum, aluminium stearate, lecithin, serum albumin, as human albumin, buffer substance is as phosphate, glycine, sorbic acid, potassium sorbate, the partial glycerol ester admixture of saturated vegetable fatty acid, water, salt or electrolyte, as protamine sulfate, sodium hydrogen phosphate, potassium hydrogen phosphate, sodium chloride, zinc salt, colloid silicon, magnesium trisilicate, polyvinylpyrrolidone, polyacrylate, wax, polyethylene-polyoxypropylene-blocking-up polymer, lanoline, sugar, as lactose, dextrose plus saccharose, starch is as corn starch and potato starch, the derivant of cellulose and it is as sodium carboxymethyl cellulose, ethyl cellulose and cellulose acetate, natural gum powder, Fructus Hordei Germinatus, gelatin, Pulvis Talci, adjuvant is as cocoa butter and suppository wax, oily as Oleum Arachidis hypogaeae semen, Oleum Gossypii semen, safflower oil, Oleum Sesami, olive oil, Semen Maydis oil and Oleum Glycines, glycols compound, as propylene glycol and Polyethylene Glycol, esters is as ethyl oleate and ethyl laurate, agar, buffer agent is as magnesium hydroxide and aluminium hydroxide, alginic acid, pyrogen-free water, Deng oozing salt, Lin Ge (family name) solution, ethanol, phosphate buffer solution, and other nontoxic proper lubrication agent are as sodium laurylsulfate and magnesium stearate, coloring agent, releasing agent, coating dress material, sweeting agent, flavoring agent and spice, antiseptic and antioxidant.
Pharmaceutical composition of the present invention can also optionally contain one or more diluent.The example of diluent comprises mannitol, sorbitol, biphosphate calcium dihydrate, microcrystalline Cellulose and efflorescence cellulose.Preferred diluent is microcrystalline Cellulose.Microcrystalline Cellulose can be obtained from several suppliers, comprises Avicel PH101, Avicel PH102, Avicel PH103, Avicel PH105 and Avicel PH200 that FMCCorporation manufactures.
Pharmaceutical composition of the present invention can also optionally contain disintegrating agent.Disintegrating agent can be the one in several modified starches, modified cellulose polymer or polycarboxylic acids, such as crosslinked Carboxymethyl cellulose sodium, Explotab, polacrilin potassium and calcium carboxymethylcellulose (CMCCalcium).In one embodiment, disintegrating agent is croscarmellose sodium.Croscarmellose sodium NF type A obtains with trade name " Ac-di-sol " on market.
Pharmaceutical composition of the present invention can also optionally contain one or more surfactants or wetting agent.Surfactant can be anion, cation or neutral surface active agent.Anion surfactant comprises sodium lauryl sulfate, dodecyl sodium sulfate, oleyl sodium sulfate and the sodium laurate mixing with stearate and Talcum.Cationic surfactant comprises benzalkonium chloride and alkyl trimethyl ammonium bromide.Neutral surface active agent comprises glycerol list olein, polyoxyethylene sorbitan fatty acid ester, polyvinyl alcohol and anhydro sorbitol fat.The embodiment of wetting agent comprises poloxamer, polyoxyethylene alkyl ether, castor oil derivatives and polyoxyethylene 8 stearate fat.
The present invention can also optionally join antioxidant in preparation, thereby gives its chemical stability.Antioxidant is selected from the extract of a-tocopherol, Y-tocopherol, S-tocopherol, tocopherol enrichment natural origin, sodium or calcium salt, the Vitamin C acyl cetylate of L-AA and it, amass wealth by heavy taxation propyl propionate, amass wealth by heavy taxation misery ester, amass wealth by heavy taxation sour dodecyl ester, Yoshinox BHT (BHT) and butylated hydroxyanisol (BHA).In one embodiment, antioxidant is BHT or BHA.
The preferred dosage form of drug composition of the present invention is the tablet of preparing by compression method.Described tablet can carry out film with the mixture such as hydroxypropyl cellulose and hydroxypropyl emthylcellulose, contains titanium dioxide and/or other coloring agent, such as ferrum oxide, dyestuff and Se Dian in this mixture; The mixture of polyvinyl alcohol (PVA) and Polyethylene Glycol (PEG), contains titanium dioxide and/or other coloring agent, such as ferrum oxide, dyestuff and Se Dian; Or any other suitable instant-free coating agent.Coating provides taste masked and other stability to final tablet.What commercially available film provided for Colorcon is preparation mixture of powders
The present invention can also add sweeting agent and/or fumet.
Compared with prior art, excellent results of the present invention is as follows:
(1) oxycodone hydrochloride dispersible tablet is made up of medicine and disintegrating agent and good excipient, therefore its in 2 minutes rapidly disintegrate be uniformly dispersed, oral after promptly disintegrate become homodisperse fine particle, be conducive to drug-eluting and absorb.
(2) taking convenience, oxycodone hydrochloride dispersible tablet can add aqueous dispersion deutostoma clothes, also can be contained in mouth and suck and take or swallow, and takes more convenient.
(3) oxycodone hydrochloride dispersible tablet has improved the stability of medicine, has ensured the quality of medicine, has extended the storage period of medicine.Sample keeps sample 6 months through accelerated test 6 months and room temperature, and significant change does not all occur for its character, dispersing uniformity, content and microorganism project, meets quality standard regulation.This product shows through the accelerated test investigation result of 6 months: indices is all stable.
The oxycodone hydrochloride dispersible tablet being made by said method all complies with relevant regulations in inspection aspect content, weight differential, stripping, disintegration, dispersing uniformity.This product can add aqueous dispersion deutostoma clothes, also can be contained in mouth and suck and take or swallow.Can be used for treatment analgesia, and for anesthesia in operating room medication.
Detailed description of the invention
Further explain the present invention below in conjunction with embodiment, but embodiment does not limit in any form to the present invention.
Embodiment 1: oxycodone hydrochloride dispersible tablet, component is as follows:
Make 1000.
Preparation method is as follows:
(1) first oxycodone hydrochloride, starch, microcrystalline Cellulose are crossed respectively to 100 mesh sieves, for subsequent use.
(2) take starch, microcrystalline Cellulose, mix homogeneously by prescription.Add the oxycodone hydrochloride of recipe quantity, mix homogeneously, adds binding agent 1% hypromellose aqueous solution soft material processed, and 20 mesh sieves are granulated, and in 50-60 DEG C of oven dry, 20 mesh sieve granulate, add cross-linking sodium carboxymethyl cellulose, magnesium stearate, silicon dioxide to mix.
(3) sample examination granule content, according to measured granule content, calculates sheet weight, tabletting.
(4) the full review of sampling, packs to obtain finished product after qualified.
Disintegration is all disintegrates by No. 2 screen clothes in 2 minutes in 37 DEG C of water, meet the pharmacopeia annex dispersible tablet regulation of disintegration.
Embodiment 2: oxycodone hydrochloride dispersible tablet, component is as follows:
Make 1000.
Preparation method is as follows:
(1) first oxycodone hydrochloride, starch, microcrystalline Cellulose are crossed respectively to 100 mesh sieves, for subsequent use.
(2) take starch, microcrystalline Cellulose, mix homogeneously by prescription.Add the oxycodone hydrochloride of recipe quantity, mix homogeneously, adds polyvinyl pyrrolidone soft material processed, and 20 mesh sieves are granulated, and in 50-60 DEG C of oven dry, 20 mesh sieve granulate, add cross-linking sodium carboxymethyl cellulose, magnesium stearate, micropowder silica gel to mix.
(3) sample examination granule content, according to measured granule content, calculates sheet weight, tabletting.
(4) the full review of sampling, packs to obtain finished product after qualified.
In 37 DEG C of water, in 2 minutes, all disintegrate, also by No. 2 screen clothes, meets the pharmacopeia annex dispersible tablet regulation of disintegration.
Embodiment 3: oxycodone hydrochloride dispersible tablet, component is as follows:
Make 1000.
Preparation method is as follows:
(1) first oxycodone hydrochloride, starch are crossed respectively to 100 mesh sieves, for subsequent use.
(2) take starch by prescription, add the oxycodone hydrochloride of recipe quantity, mix homogeneously, add binding agent 5% starch slurry soft material processed, 20 mesh sieves are granulated, in 50-60 DEG C of oven dry, 20 mesh sieve granulate, add polyvinylpolypyrrolidone, magnesium stearate, silica sol to mix.
(3) sample examination granule content, according to measured granule content, calculates sheet weight, tabletting.
(4) the full review of sampling, packs to obtain finished product after qualified.
Disintegration is all disintegrates by No. 2 screen clothes in 2 minutes in 37 DEG C of water, meet the pharmacopeia annex dispersible tablet regulation of disintegration.
Embodiment 4: oxycodone hydrochloride dispersible tablet, component is as follows:
Preparation method is as follows:
(1) first oxycodone hydrochloride, starch, carboxymethyl starch sodium are crossed respectively to 100 mesh sieves, for subsequent use.
(2) take starch, carboxymethyl starch sodium, mix homogeneously by prescription.Add the oxycodone hydrochloride of recipe quantity, mix homogeneously, adds binding agent 1% hypromellose aqueous solution soft material processed, and 20 mesh sieves are granulated, and in 50-60 DEG C of oven dry, 20 mesh sieve granulate, add low-substituted hydroxypropyl cellulose and magnesium stearate to mix.
(3) sample examination granule content, according to measured granule content, calculates sheet weight, tabletting.
(4) the full review of sampling, packs to obtain finished product after qualified.
Disintegration is all disintegrates by No. 2 screen clothes in 2 minutes in 37 DEG C of water, meet the pharmacopeia annex dispersible tablet regulation of disintegration.
Biological activity test
3 batches of following three kinds of tests are embodiment 1 formulation and technology and prepare.
(1) table 1 is dissolution (%) comparative result of oxycodone hydrochloride dispersible tablet and commercially available oxycodone hydrochloride ordinary tablet (the plain pharmacy of Beijing China, 5mg/ sheet).
With reference to dissolution method (2010 editions two annex XC bis-methods of Chinese Pharmacopoeia).
Ordinary tablet cumulative percentage dissolution (%) is sold relatively in table 1 oxycodone hydrochloride dispersible tablet and market
As can be seen from Table 1, the dissolution in vitro of oxycodone hydrochloride dispersible tablet in 10-30min is obviously better than ordinary tablet.
(2) oxycodone hydrochloride dispersible tablet assay
Measure with reference to high-efficient liquid phase technique (two annex VD of Chinese Pharmacopoeia version in 2010).
Table 2 oxycodone hydrochloride dispersible tablet assay
| Batch | Oxycodone hydrochloride dispersible tablet content (%) |
| Batch 1 | 100.28 |
| Batches 2 | 100.25 |
| Batches 3 | 100.26 |
As can be seen from Table 2, the content of the oxycodone hydrochloride dispersible tablet requirement that conforms with the regulations.
(3) the quality stability comparison of oxycodone hydrochloride dispersible tablet
Oxycodone hydrochloride dispersible tablet accelerated test: the oxycodone hydrochloride dispersible tablet of blister package is put under 2 DEG C of 40 DEG C of scholars of temperature, relative humidity 75% scholar's 5% condition and placed six months, outcome quality is stable, and indices is as shown in table 3.
Six months accelerated test testing results of table 3 oxycodone hydrochloride dispersible tablet
| Inspection batch | Outward appearance | Disintegration/s | Dispersing uniformity | Dissolution % | Content % |
| Batch 1 | White is smooth | 36 | Conform with the regulations | 100.32 | 100.25 |
| Batches 2 | White is smooth | 39 | Conform with the regulations | 100.29 | 100.22 |
| Batches 3 | White is smooth | 37 | Conform with the regulations | 100.34 | 100.26 |
Claims (6)
1. an oxycodone hydrochloride dispersible tablet, the component that it comprises following percentage by weight:
Oxycodone hydrochloride 1～5%
Disintegrating agent 50～95%
Lubricant and fluidizer 1～10%
Binding agent 1～10%.
2. oxycodone hydrochloride dispersible tablet according to claim 1, wherein, described disintegrating agent is one or more in starch, modified starch, cellulose powder, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, alginic acid, kaolin, veegum, silica sol.
3. oxycodone hydrochloride dispersible tablet according to claim 1, wherein, described lubricant and fluidizer are one or more in stearic acid, magnesium stearate, zinc stearate, calcium stearate, hard paraffin, hydrogenated vegetable oil, politef, Polyethylene Glycol, sodium benzoate, sodium laurylsulfate, glyceryl monostearate, monopalmitin, spermol, silicon dioxide, micropowder silica gel, Pulvis Talci, hydrated sodium aluminosilicate.
4. oxycodone hydrochloride dispersible tablet according to claim 1, wherein, described binding agent is one or more in hypromellose, starch slurry, dextrin, syrup, maltose, gelatine size, polyvinylpyrrolidone, Polyethylene Glycol, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, mucialga of arabic gummy.
5. according to the oxycodone hydrochloride dispersible tablet described in claim 1-4 any one, the component that it comprises following percentage by weight:
Make 1000.
6. a preparation method for oxycodone hydrochloride dispersible tablet claimed in claim 1, it comprises following steps:
(1) oxycodone hydrochloride, adjuvant are crossed respectively to 100 mesh sieves, for subsequent use;
(2) take disintegrating agent by recipe quantity, add the oxycodone hydrochloride of recipe quantity, mix homogeneously;
(3) add binding agent to be mixed and made into soft material, granulate with 18-24 mesh sieve, granule is dried under 50-80 DEG C of condition;
(4) after granule is dried, 20 mesh sieve granulate;
(5) add disintegrating agent, lubricant and fluidizer to mix;
(6) sample examination, in mensuration granule, the content of oxycodone hydrochloride, determines sheet weight, tabletting, obtains oxycodone hydrochloride dispersible tablet.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021028640A1 (en) * | 2019-08-13 | 2021-02-18 | Ethypharm | Low-dosage orodispersible opioid tablet and method for preparing same |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1555794A (en) * | 2004-01-02 | 2004-12-22 | 肖广常 | Orazitan dispersion tablet and its preparation method |
| CN101264329A (en) * | 2008-04-25 | 2008-09-17 | 北京阜康仁生物制药科技有限公司 | Medicinal composition for diminishing inflammation and ease pain and preparation and use thereof |
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2014
- 2014-03-25 CN CN201410114111.5A patent/CN103877047A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1555794A (en) * | 2004-01-02 | 2004-12-22 | 肖广常 | Orazitan dispersion tablet and its preparation method |
| CN101264329A (en) * | 2008-04-25 | 2008-09-17 | 北京阜康仁生物制药科技有限公司 | Medicinal composition for diminishing inflammation and ease pain and preparation and use thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021028640A1 (en) * | 2019-08-13 | 2021-02-18 | Ethypharm | Low-dosage orodispersible opioid tablet and method for preparing same |
| FR3099881A1 (en) * | 2019-08-13 | 2021-02-19 | Ethypharm Sa | Low strength opioid orodispersible tablet and its preparation method. |
| CN114258300A (en) * | 2019-08-13 | 2022-03-29 | 埃迪制药公司 | Low dose orodispersible opioid tablet and method of making same |
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Application publication date: 20140625 |