CN102552107B - Two-phase release preparation containing zolpidem or salt of zolpidem and preparation method thereof - Google Patents
Two-phase release preparation containing zolpidem or salt of zolpidem and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a two-phase release preparation containing zolpidem or salt of zolpidem, which is characterized by comprising a normal medicine-containing fast release preparation and enteric fast release preparation and being suitable for respectively releasing zolpidem or salt of zolpidem in two preset periods of time. More than 90% dose of the normal medicine-containing fast release preparation is released within 30 minutes in 0.01M of hydrochloric acid buffer solution at 37 DEG C, and more than 90% dose of the enteric fast release preparation is released within 30 minutes in phosphate buffer solution of 6.8 potential of hydrogen (pH) at 37 DEG C. The two-phase release preparation containing zolpidem or salt of zolpidem is specific to the sleep characteristics of a patient with sleep difficulties and early waking, and has effects on patients with both sleeping difficulties and early waking simultaneously.
Description
Technical field
The present invention relates to the two-phase delivery formulations of a kind of zolpidem or its salt, the invention still further relates to the preparation method of the two-phase delivery formulations of this zolpidem or its salt.
Background technology
Insomnia is a kind of common sleep disorder, the difficulty falling asleep, the Depth of sleep that cause for a variety of causes are shallow or frequency is too short, early awakening and the length of one's sleep not enough or of poor quality etc.The common reason of insomnia that causes mainly contains environment reason, individual factors, body reason, Nervous and Mental Factors, emotional factor etc.Wherein, early awakening refers to weekly more than four times than the Zao 2-3 of normal condition hour or longer time awakening, and the phenomenon that can not again fall asleep.The people of insomnia is usually simultaneously with difficulty falling asleep and early awakening.The effective acting time of most of sleeping pill is generally at 4-6h, takes medicine routinely before sleep, treats difficulty falling asleep and early awakening symptom cannot be proved effective simultaneously, and this is also a blank in treatment of sleep disorders.
Zolpidem, a kind of Imidazopyridine class sedative hypnotic drug, Main Function is 1 receptor of the ω on GABA-BZDA subunit in brain, has stronger sedative-hypnotic effect and slight anxiety, of flaccid muscles and anticonvulsant action.Americanism obstacle diagnosis and statistic handbook the 4th edition are mentioned the choice drug that Non-benzodiazepine hypnotic drug zolpidem can be used as Primary insomnia.This medicine is developed by French Sanofi-Aventis company the earliest, for first Non-benzodiazepine sleeping pill, Zolpidemtar Trate conventional tablet is in Initial Public Offering in 1988, in December, 1992 is examined approval by U.S. FDA, in the U.S. and Chinese Time To Market, be respectively 1993 and 1996, successively in states such as American and Britain ,De, Switzerland, Spain, be widely used, all over the world, as sedative hypnotic, be widely used, have the trend that progressively replaces benzodiazepine.Oral zolpidem ordinary preparation, bioavailability is 70%, blood drug level peaking after medication 0.5-3h, average half-life is 2.4h, the persistent period is less than 6h.Improved slow releasing tablet for this reason, and in the listing of the 2005 Nian U.S., ProductName Ambian CR.
Zolpidem belongs to fugitive sleeping pill, and its half-life is short, and action time is short.In order to solve short problem of zolpidem half-life.CN1334729A discloses the controlled release preparation of a kind of zolpidem or its salt, and in said preparation, contained drug can present two-phase release in the scheduled time, and wherein first-phase is rapid release phase, and second-phase is slow release phase.But a large amount of clinical cases find, under the effect of sleeping pill,, then there is early awakening symptom in the patient 3-4 hour that at least can sleep peacefully.Therefore by slow releasing preparation, continue medication, the time administration that especially originally can sleep peacefully patient just seems and there is no need.After 3-4 hour, often because medicine discharged complete do not reach effective drug level and to early awakening bundle in hopeless.Simultaneously slow releasing preparation because of its release time longer, because of patient's individual variation, be difficult to effectively control rational blood drug level level, cause the symptoms such as most of patients m seq has one's head in the clouds, impact normal operation and life.
In addition, pulse site-specific drug delivery mini-pill when CN101574328 discloses selecting of a kind of zolpidem salt, the outer time lag layer for the hypotonicity acrylic resin coating with containing quaternary ammonium salt group of its micropill, having controlled intermediate layer medicine and organic acid discharges, time hysteresis through after a while discharges medicine, during this selecting, pulse site-specific drug delivery mini-pill is only for the symptom of early awakening, and the difficulty falling asleep being usually accompanied for early awakening symptom does not have therapeutic effect.
Summary of the invention
The invention provides the two-phase delivery formulations of a kind of zolpidem or its salt, it is characterized in that it is comprised of common pastille quick releasing formulation and enteric-coated quick releasing formulation two parts, in two periods that are adapted at being scheduled to, discharge respectively zolpidem or its salt, common pastille quick releasing formulation more than 90% the discharging in 30min of its dose in the hydrochloride buffer of the 0.01M of 37 ℃, enteric-coated quick releasing formulation more than 90% the discharging in 30min of its dose in pH6.8 phosphate buffer.
Preferably, described enteric-coated quick releasing formulation burst size of 0-2 hour in the hydrochloride buffer of the 0.01M of 37 ℃ is less than 10%.
More preferably, total content of dispersion of described zolpidem or its salt is calculated as 6-16mg by zolpidem.
More preferably, described zolpidem or its salt are Zolpidemtar Trate.
Preferably, described enteric-coated quick releasing formulation comprises zolpidem or its salt, and receivable enteric material on pharmaceutics.
More preferably, described enteric material is one or more in crylic acid resin, hydroxypropyl methylcellulose diethyl phthalate, Hydroxypropyl Methyl Cellulose Phthalate, and its weight accounts for the 60%-90% of whole enteric-coated quick releasing formulation weight.
More preferably, described enteric-coated quick releasing formulation also comprises plasticizer, and described plasticizer comprises phthalate, one or more in citric acid ester type, Polyethylene Glycol, stearic acid, and its weight accounts for the 10%-40% of whole enteric-coated quick releasing formulation weight.
More preferably, described two-phase delivery formulations is tablet, and its preparation method is as follows:
A. medicine is mixed homogeneously with other adjuvant except lubricant, add mix lubricant even, make common pastille quick releasing formulation;
B. medicine is mixed homogeneously with filler, add wetting agent soft material processed, extrude round as a ballly, obtain rapid release ball core, enteric coated, make enteric-coated quick releasing formulation;
C. common pastille quick releasing formulation is mixed homogeneously with enteric-coated quick releasing formulation, tabletting, obtains.
More preferably, described two-phase delivery formulations is powder, and wherein each phase scalable dosage is to realize individual administration.
Or more preferably, described two-phase delivery formulations is capsule, wherein each phase scalable dosage is to realize individual administration.
The present invention is directed to difficulty falling asleep and early awakening patient's sleep characteristics, for simultaneously all effective with the patient of difficulty falling asleep and early awakening.Before sleeping, take two-phase delivery formulations of the present invention, wherein common pastille quick releasing formulation instant performance drug effect in 30 minutes, helps patient to fall asleep as early as possible; Through after a period of time, blood drug level reduces, but patient still can keep sleep, enteric-coated quick releasing formulation interval discharges for 2-4 hour again, reach rapidly treatment blood drug level level, make patient when being about to awaken, obtain effective blood drug concentration, thereby extend patient's the length of one's sleep.Owing to adopting enteric material, enteric-coated quick releasing formulation is mainly at intestinal absorption, and enteric coating has been avoided the hydrolysis of gastric enzyme, thereby escapes enzyme barrier, has improved the bioavailability of medicine at enteral.Medicine must could dissolve release through gastric emptying to intestinal, has reduced individual variation, and release time is relatively accurate.Alleviated because of slow releasing preparation longlyer release time simultaneously, and maintained for a long time certain blood drug level, to patient, brought the m seq malaise symptoms such as have one's head in the clouds.In addition, due to the compaction of pellet technology that adopts common pastille powder to mix with enteric-coated quick releasing ball core, it is compared and has more advantage with two release capsules and with double-deck fast slow releasing tablet: as realized two delivery formulations that dosage is cut apart; Do not use gelatine capsule shell, avoided the problem of aging that is prone in depositing, when taking medicine, avoided capsule to stick to the problem that in esophagus, impact discharges simultaneously yet.
Accompanying drawing explanation
Fig. 1 shows according to release graphics in the body of embodiments of the invention.
The specific embodiment
Embodiment 1: containing the two-phase releasing piece of 10mg Zolpidemtar Trate
Common pastille rapid release powder:
Prescription:
Technique: by the Zolpidemtar Trate of recipe quantity, lactose/starch mixture, microcrystalline Cellulose PH102, Macrogol 4000, carboxymethyl starch sodium mix homogeneously, adds the magnesium stearate of recipe quantity, and mix homogeneously, obtains.
Enteric-coated quick releasing micropill
Ball core
Enteric coating
Technique: by the Zolpidemtar Trate of recipe quantity, microcrystalline Cellulose PH101, low-substituted hydroxypropyl cellulose, sucrose mix homogeneously, add 10% starch slurry soft material processed, extrudes round as a ballly, makes rapid release ball core, enteric coating, coating weightening finish 10-15%.
The immediate-release granules preparing is mixed homogeneously with enteric coated particles, tabletting and get final product.
Adopt Chinese Pharmacopoeia (version in 2010) appendix II Their Dissolution Test in vitro method, two methods, using 900ml0.01M hydrochloric acid as first stage release medium, keep 37 ℃, slurry method stirs (50rpm), at 5min, 15min, 30min, 1h, 2h, samples respectively.Release medium is adjusted to pH6.8, and respectively at 5min, 15min, 30min and 45min sampling, by measuring 270nm place UV Absorption degree, determine stripping percent.
Result is illustrated in table 1.Show that common pastille quick releasing formulation was complete stripping in 15 minutes; in 15min-2h interval, remain unchanged; illustrate that enteric coating well protected rapid release ball core in acid medium, avoid it in acid medium, to discharge, the final stripping of hydrochloric acid of 0.1M is not as the hydrochloric acid solution of 0.01M.In pH6.8 buffer, enteric coated micropill part discharges completely in 15min.Whole release profiles is stepped, two-phase rapid release characteristic.
Table 1
Embodiment 2: containing the two-phase releasing piece of 12.5mg Zolpidemtar Trate
Common pastille rapid release powder
Technique: by the Zolpidemtar Trate of recipe quantity, mannitol, microcrystalline Cellulose PH200, cross-linking sodium carboxymethyl cellulose mix homogeneously, adds the calcium stearate of recipe quantity, and mix homogeneously, obtains.
Enteric-coated quick releasing micropill
Ball core
Enteric coating
Technique: by the Zolpidemtar Trate of recipe quantity, microcrystalline Cellulose PH101, low-substituted hydroxypropyl cellulose, lactose mix homogeneously, add 0.1% sodium carboxymethyl cellulose soft material processed, extrude (35rpm) round as a ball (600rpm), make rapid release ball core, enteric coating, coating weightening finish 25-30%.
The immediate-release granules preparing is mixed homogeneously with enteric coated particles, tabletting and get final product.
Adopt Chinese Pharmacopoeia (version in 2010) appendix II Their Dissolution Test in vitro method, two methods, using 900ml0.01M hydrochloric acid as first stage release medium, keep 37 ℃, slurry method stirs (50rpm), at 5min, 15min, 30min, 1h, 2h, samples respectively.Release medium is adjusted to pH6.8, and respectively at 5min, 15min, 30min and 45min sampling, determine stripping percent by measuring 270nm place UV Absorption degree.
Result is illustrated in table 2.Show that common pastille quick releasing formulation was complete stripping in 15 minutes; in 15min-2h interval, remain unchanged; illustrate that enteric coating well protected rapid release ball core in acid medium, avoid it in acid medium, to discharge, the final stripping of hydrochloric acid of 0.1M is not as the hydrochloric acid solution of 0.01M.In pH6.8 buffer, enteric coated micropill part discharges completely in 15min.Whole release profiles is stepped, two-phase rapid release characteristic.
Table 2
Embodiment 3: containing the two-phase releasing piece of 12.5mg Zolpidemtar Trate
Common pastille rapid release powder:
Technique: by the Zolpidemtar Trate of recipe quantity, lactose, microcrystalline Cellulose PH102, carboxymethyl starch sodium mix homogeneously, adds the magnesium stearate of recipe quantity, and mix homogeneously, obtains.
Enteric-coated quick releasing micropill:
Enteric coating:
Technique: by the Zolpidemtar Trate of recipe quantity, microcrystalline Cellulose PH101, polyvinylpolypyrrolidone, ethylmethylcellulose mix homogeneously, add 10% pregelatinized Starch slurry soft material processed, extrudes round as a ballly, makes rapid release ball core, enteric coating, the coating 15-25% that increases weight.
The immediate-release granules preparing is mixed homogeneously with enteric coated particles, tabletting and get final product.
Adopt Chinese Pharmacopoeia (version in 2010) appendix II Their Dissolution Test in vitro method, two methods, using 900ml0.01M hydrochloric acid as first stage release medium, keep 37 ℃, slurry method stirs (50rpm), at 5min, 15min, 30min, 1h, 2h, samples respectively.Release medium is adjusted to pH6.8, and respectively at 5min, 15min, 30min and 45min sampling, by measuring 270nm place UV Absorption degree, determine stripping percent.
Result is illustrated in table 3.Show that common pastille quick releasing formulation was complete stripping in 15 minutes; in 15min-2h interval, remain unchanged; illustrate that enteric coating well protected rapid release ball core in acid medium, avoid it in acid medium, to discharge, the final stripping of hydrochloric acid of 0.1M is not as the hydrochloric acid solution of 0.01M.In pH6.8 buffer, enteric coated micropill part discharges completely in 15min.Whole release profiles is stepped, two-phase rapid release characteristic.
Table 3
Embodiment 4: containing the two-phase releasing piece of 12.5mg Zolpidemtar Trate
Common pastille rapid release powder:
Technique: by the Zolpidemtar Trate of recipe quantity, lactose, microcrystalline Cellulose PH102, carboxymethyl starch sodium mix homogeneously, adds the magnesium stearate of recipe quantity, and mix homogeneously, obtains.
Enteric-coated quick releasing micropill:
Enteric coating:
Technique: by the Zolpidemtar Trate of recipe quantity, microcrystalline Cellulose PH101, polyvinylpolypyrrolidone, ethylmethylcellulose mix homogeneously, add 10% pregelatinized Starch slurry soft material processed, extrudes round as a ballly, makes rapid release ball core, enteric coating, the coating 15-25% that increases weight.
The immediate-release granules preparing is mixed homogeneously with enteric coated particles, tabletting and get final product.
Adopt Chinese Pharmacopoeia (version in 2010) appendix II Their Dissolution Test in vitro method, two methods, using 900ml0.01M hydrochloric acid as first stage release medium, keep 37 ℃, slurry method stirs (50rpm), at 5min, 15min, 30min, 1h, 2h, samples respectively.Release medium is adjusted to pH6.8, and respectively at 5min, 15min, 30min and 45min sampling, by measuring 270nm place UV Absorption degree, determine stripping percent.
Result is illustrated in table 4.Show that common pastille quick releasing formulation was complete stripping in 15 minutes; in 15min-2h interval, remain unchanged; illustrate that enteric coating well protected rapid release ball core in acid medium, avoid it in acid medium, to discharge, the final stripping of hydrochloric acid of 0.1M is not as the hydrochloric acid solution of 0.01M.In pH6.8 buffer, enteric coated micropill part discharges completely in 15min.Whole release profiles is stepped, two-phase rapid release characteristic.
Table 4
Embodiment 5: containing the two-phase releasing piece of 4mg Zolpidemtar Trate
Common pastille rapid release powder
Technique: by the Zolpidemtar Trate of recipe quantity, lactose/starch mixture, microcrystalline Cellulose PH102, Macrogol 4000, carboxymethyl starch sodium mix homogeneously, adds the magnesium stearate of recipe quantity, and mix homogeneously, obtains.
Enteric-coated quick releasing micropill
Ball core
Enteric coating
Technique: by the Zolpidemtar Trate of recipe quantity, microcrystalline Cellulose PH101, low-substituted hydroxypropyl cellulose, sucrose mix homogeneously, add 10% starch slurry soft material processed, extrudes round as a ballly, makes rapid release ball core, enteric coating, coating weightening finish 10-15%.
The immediate-release granules preparing is mixed homogeneously with enteric coated particles, tabletting and get final product.
Adopt Chinese Pharmacopoeia (version in 2010) appendix II Their Dissolution Test in vitro method, two methods, using 900ml0.01M hydrochloric acid as first stage release medium, keep 37 ℃, slurry method stirs (50rpm), at 5min, 15min, 30min, 1h, 2h, samples respectively.Release medium is adjusted to pH6.8, and respectively at 5min, 15min, 30min and 45min sampling, by measuring 270nm place UV Absorption degree, determine stripping percent.
Result is illustrated in table 5.Show that common pastille quick releasing formulation was complete stripping in 15 minutes; in 15min-2h interval, remain unchanged; illustrate that enteric coating well protected rapid release ball core in acid medium, avoid it in acid medium, to discharge, the final stripping of hydrochloric acid of 0.1M is not as the hydrochloric acid solution of 0.01M.In pH6.8 buffer, enteric coated micropill part discharges completely in 15min.Whole release profiles is stepped, two-phase rapid release characteristic.
Table 5
Embodiment 6: containing the two-phase releasing piece of 16mg Zolpidemtar Trate
Common pastille rapid release powder
Technique: by the Zolpidemtar Trate of recipe quantity, lactose/starch mixture, microcrystalline Cellulose PH102, Macrogol 4000, carboxymethyl starch sodium mix homogeneously, adds the magnesium stearate of recipe quantity, and mix homogeneously, obtains.
Enteric-coated quick releasing micropill
Ball core
Enteric coating
Technique: by the Zolpidemtar Trate of recipe quantity, microcrystalline Cellulose PH101, low-substituted hydroxypropyl cellulose, sucrose mix homogeneously, add 10% starch slurry soft material processed, extrudes round as a ballly, makes rapid release ball core, enteric coating, coating weightening finish 10-15%.
The immediate-release granules preparing is mixed homogeneously with enteric coated particles, tabletting and get final product.
Adopt Chinese Pharmacopoeia (version in 2010) appendix II Their Dissolution Test in vitro method, two methods, using 900ml0.01M hydrochloric acid as first stage release medium, keep 37 ℃, slurry method stirs (50rpm), at 5min, 15min, 30min, 1h, 2h, samples respectively.Release medium is adjusted to pH6.8, and respectively at 5min, 15min, 30min and 45min sampling, by measuring 270nm place UV Absorption degree, determine stripping percent.
Result is illustrated in table 6.Show that common pastille quick releasing formulation was complete stripping in 15 minutes; in 15min-2h interval, remain unchanged; illustrate that enteric coating well protected rapid release ball core in acid medium, avoid it in acid medium, to discharge, the final stripping of hydrochloric acid of 0.1M is not as the hydrochloric acid solution of 0.01M.In pH6.8 buffer, enteric coated micropill part discharges completely in 15min.Whole release profiles is stepped, two-phase rapid release characteristic.
Table 6
Be more than that the immediate-release granules preparing is mixed homogeneously with enteric coated particles, tabletting makes tablet.Immediate-release granules and enteric coated particles can also be prepared as to powder or the capsule of comparting packaging, patient can be according to the sleep feature of oneself and the tolerance degree to medicine, and the dose personalized medicine of amounting to according to the volume of granule, does not repeat them here.
Although embodiment of the present invention are open as above, but it is not restricted to listed utilization in description and embodiment, it can be applied to various applicable the field of the invention completely, for those skilled in the art, can easily realize other modification, therefore do not deviating under the general concept that claim and equivalency range limit, the present invention is not limited to specific details and illustrates here and the legend of describing.
Claims (7)
1. the two-phase delivery formulations of a zolpidem or its salt, it is characterized in that it is comprised of common pastille quick releasing formulation and enteric-coated quick releasing formulation two parts, wherein, described enteric-coated quick releasing formulation comprises zolpidem or its salt, and acceptable enteric material on pharmaceutics, described enteric material is crylic acid resin, hydroxypropyl methylcellulose diethyl phthalate, one or more in Hydroxypropyl Methyl Cellulose Phthalate, its weight accounts for the 60%-90% of whole enteric-coated quick releasing formulation weight, in two periods that described preparation is adapted at being scheduled to, discharge respectively zolpidem or its salt, common pastille quick releasing formulation more than 90% the discharging in 30min of its dose in the hydrochloride buffer of the 0.01M of 37 ℃, enteric-coated quick releasing formulation more than 90% the discharging in 30min of its dose in pH6.8 phosphate buffer, described enteric-coated quick releasing formulation burst size of 0-2 hour in the hydrochloride buffer of the 0.01M of 37 ℃ is less than 10%.
2. the two-phase delivery formulations of zolpidem as claimed in claim 1 or its salt, is characterized in that, total content of dispersion of described zolpidem or its salt is calculated as 6-16mg by zolpidem.
3. the two-phase delivery formulations of zolpidem as claimed in claim 2 or its salt, is characterized in that, described zolpidem or its salt are Zolpidemtar Trate.
4. the two-phase delivery formulations of zolpidem as claimed in claim 3 or its salt, it is characterized in that, described enteric-coated quick releasing formulation also comprises plasticizer, described plasticizer comprises phthalate, one or more in citric acid ester type, Polyethylene Glycol, stearic acid, its weight accounts for the 10%-40% of whole enteric-coated quick releasing formulation weight.
5. the two-phase delivery formulations of zolpidem as claimed in claim 4 or its salt, is characterized in that, described two-phase delivery formulations is tablet, and its preparation method is as follows:
A. medicine is mixed homogeneously with other adjuvant except lubricant, add mix lubricant even, make common pastille quick releasing formulation;
B. medicine is mixed homogeneously with filler, add wetting agent soft material processed, extrude round as a ballly, obtain rapid release ball core, enteric coated, make enteric-coated quick releasing formulation;
C. common pastille quick releasing formulation is mixed homogeneously with enteric-coated quick releasing formulation, tabletting, obtains.
6. the two-phase delivery formulations of zolpidem as claimed in claim 4 or its salt, is characterized in that, described two-phase delivery formulations is powder, and wherein each phase scalable dosage is to realize individual administration.
7. the two-phase delivery formulations of zolpidem as claimed in claim 4 or its salt, is characterized in that, described two-phase delivery formulations is capsule, and wherein each phase scalable dosage is to realize individual administration.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1334729A (en) * | 1998-12-04 | 2002-02-06 | 圣诺菲-合成实验室公司 | Controlled-release dosage forms comprising zolpidem or salt thereof |
| CN101574328A (en) * | 2009-06-18 | 2009-11-11 | 中国药科大学 | Timing pulsed release micro-pill of zolpidem salt |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1334729A (en) * | 1998-12-04 | 2002-02-06 | 圣诺菲-合成实验室公司 | Controlled-release dosage forms comprising zolpidem or salt thereof |
| CN101574328A (en) * | 2009-06-18 | 2009-11-11 | 中国药科大学 | Timing pulsed release micro-pill of zolpidem salt |
Non-Patent Citations (2)
| Title |
|---|
| 谢齐昂等.酒石酸唑吡坦双脉冲控释微丸的研制.《中国药学杂志》.2009,第44卷(第17期), |
| 酒石酸唑吡坦双脉冲控释微丸的研制;谢齐昂等;《中国药学杂志》;20090930;第44卷(第17期);第1312-1320页 * |
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