CN105796514A - Alogliptin benzoate oral disintegrating tablet and preparation method thereof - Google Patents
Alogliptin benzoate oral disintegrating tablet and preparation method thereof Download PDFInfo
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- CN105796514A CN105796514A CN201410845140.9A CN201410845140A CN105796514A CN 105796514 A CN105796514 A CN 105796514A CN 201410845140 A CN201410845140 A CN 201410845140A CN 105796514 A CN105796514 A CN 105796514A
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Abstract
The invention relates to the field of drug alogliptin benzoate for treatment of type II diabetes, in particular to an alogliptin benzoate oral disintegrating tablet and a preparation method thereof. The invention discloses the alogliptin benzoate oral disintegrating tablet composed of alogliptin benzoate and acceptable pharmaceutical excipients. The alogliptin benzoate oral disintegrating tablet consists of 1-45 parts of alogliptin benzoate, 1-85 parts of a diluents, 20-95 parts of an adhesive, 1-60 parts of a disintegrating agent, 0.01-10 parts of a flavoring agent, 0.01-15 parts of a lubricant, and 0.01-12 parts of a flow aid. The alogliptin benzoate oral disintegrating tablet disclosed by the invention has the characteristics of smooth and bright surface, no splinter or sticking, and no cracking phenomenon during transportation. At the same time, during clinical application, the tablet can disintegrate rapidly in the oral cavity without auxiliary water drinking, the tablet is free of gritty feel and has good mouthfeel, and has a dissolution rate in a diluted hydrochloric acid solution up to more than 90%.
Description
Technical field
The present invention relates to treatment type Ⅱdiabetes mellitus medicine Egelieting field, relate in particular to Egelieting oral cavity disintegration tablet and preparation method thereof, belong to pharmaceutical preparation research field.
Background technology
Diabetes be a kind of with blood glucose rising be common trait endocrine, metabolic disease, it it is a kind of chronic disease perplexing the whole world, the current whole world there are about 2.3 hundred million patients, estimate that diabetic number in 2025 will be added to 300,000,000, the many sequela at 35～40 years old of type Ⅱdiabetes mellitus, account for diabetic more than 90%, in recent years also have the trend of rising along with the sickness rate in growth in the living standard child.Type Ⅱdiabetes mellitus becomes frequently-occurring disease common after tumor, cardiovascular and cerebrovascular disease, and its medication market expands year by year.
Egelieting (Alogliptinbenzoate) is a kind of serine protease DPP IV (DPP-IV) inhibitor for treating type Ⅱdiabetes mellitus.DPP-IV is a kind of transmembrane protein molecule, the cell of blood plasma and a lot of tissue is widely present, its degraded inactivation can be caused by the 2nd alanine of N end of hydrolysis glucagon-like-peptide-1 (GLP-1), Egelieting can by suppressing this enzyme to improve GLP-1 concentration, promote islet cells to produce insulin, reduce Glucagon concentrations simultaneously.
Up to the present, SYR-322 can be used for the patients with NIDDM that following glycemic control is bad: diet alone and Exercise therapy for treatment of knee joint person, and can be used alone SYR-322；Diet and exercise therapy and alpha-glucosidase inhibitor (α-glucosidaseinhibitor) or thiazolidinediones therapist, can add and use SYR-322.SYR-322 has very strong targeting specific, and when glucose is normal, this medicine does not have activity, is not result in hypoglycemia.The toleration of Patients with NIDDM para Toluic Acid's Egelieting is good, without dose-limiting toxicity, drug accumulation phenomenon does not occur when multiple dose administration, the infull patient of Liver and kidney function is also without adjusting dosage and the impact of Pharmacokinetic Results also unable to take food thing, also do not find severely adverse event and dead case under study for action, drop by the wayside because of untoward reaction also without patient.
In April, 2010, SYR-322 obtain Japan listing approval, commercialized product is the tablet of SYR-322, and specification has three kinds, respectively 6.25mg/ sheet, 12.5mg/ sheet, 25mg/ sheet.Adjuvant is mannitol, microcrystalline Cellulose, hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, magnesium stearate, hypromellose, titanium dioxide and pigment.
Summary of the invention
The inventors found that product in the market is conventional tablet, for the patient of old people, child and dysphagia, compliance is poor；Under water deficit conditions, the use of Egelieting tablet has been also affected by serious restriction simultaneously.
Accordingly, it is intended to find a kind of new Egelieting product forms, thus Problems existing in overcoming Egelieting product to use.
In order to realize this purpose, we disclose a kind of Egelieting oral cavity disintegration tablet being made up of SYR-322 and acceptable excipient substance, described Egelieting oral cavity disintegration tablet is made up of SYR-322 and diluent, binding agent, disintegrating agent, correctives, lubricant and the fluidizer of recipe quantity, and wherein each components by weight is SYR-322 1 ~ 45 part, diluent 1 ~ 85 part, binding agent 20 ~ 95 parts, disintegrating agent 1 ~ 60 part, correctives 0.01 ~ 10 part, lubricant 0.01 ~ 15 part, fluidizer 0.01 ~ 12 part.
The wherein said benzoate that active ingredient benzoic acid Egelieting is Egelieting, molecular formula is C18H21N5O2.C7H6O2, molecular weight is 461.51, and structural formula is:
Preferred as one, described each components by weight is, SYR-322 4 ~ 30 parts, diluent 10 ~ 60 parts, binding agent 40 ~ 85 parts, disintegrating agent 5 ~ 45 parts, correctives 0.5 ~ 3 part, lubricant 0.5 ~ 3 part, fluidizer 0.5 ~ 3 part.
Wherein binding agent more preferably scope is 70 ~ 80 parts, and the scope that correctives is more highly preferred to is 1%, and the scope that lubricant is more highly preferred to is 1%, and the scope that fluidizer is more highly preferred to is 1%.
Meanwhile, diluent therein, binding agent, disintegrating agent, correctives, lubricant and fluidizer are disclosed its preferred version by the present invention further:
Wherein said diluent is one or more mixture in pregelatinized Starch, mannitol, lactose, polyvinylpolypyrrolidone.
Described binding agent is water.
Described disintegrating agent is one or more mixture in microcrystalline Cellulose, pregelatinized Starch, polyvinylpolypyrrolidone, L-hydroxypropyl cellulose.
Described correctives is Aspartane and/or cyclamate.
Described lubricant is magnesium stearate and/or Pulvis Talci.
Described fluidizer is micropowder silica gel.
In the present invention, we also disclosed a kind of method preparing Egelieting oral cavity disintegration tablet, its preparation method comprises the following steps,
(1) active ingredient benzoic acid Egelieting being crossed 100 mesh sieves, 80 mesh sieves crossed by other all adjuvants, standby；
(2) diluent of recipe quantity, disintegrating agent, correctives and fluidizer and SYR-322 are mixed, obtain mixture A；
(3) binding agent of recipe quantity is added mixture A to granulate, dry, obtain granule B after granulate；
(4) lubricant is added in granule B, mixing, tabletting, obtain Egelieting oral cavity disintegration tablet.
Wherein, SYR-322 1 ~ 45 part, diluent 1 ~ 85 part, binding agent 20 ~ 95 parts, disintegrating agent 1 ~ 60 part, correctives 0.01 ~ 10 part, lubricant 0.01 ~ 15 part, fluidizer 0.01 ~ 12 part；Preferably, SYR-322 4 ~ 30 parts, diluent 10 ~ 60 parts, binding agent 40 ~ 85 parts, disintegrating agent 5 ~ 45 parts, correctives 0.5 ~ 3 part, lubricant 0.5 ~ 3 part, fluidizer 0.5 ~ 3 part.
Wherein binding agent more preferably scope is 70 ~ 80 parts, and the scope that correctives is more highly preferred to is 1%, and the scope that lubricant is more highly preferred to is 1%, and the scope that fluidizer is more highly preferred to is 1%.
Meanwhile, wherein the diluent of indication is one or more mixture in pregelatinized Starch, mannitol, lactose, polyvinylpolypyrrolidone；Binding agent is water；Disintegrating agent is one or more mixture in microcrystalline Cellulose, pregelatinized Starch, polyvinylpolypyrrolidone, L-hydroxypropyl cellulose；Correctives is Aspartane and/or cyclamate；Lubricant is magnesium stearate and/or Pulvis Talci；Fluidizer is micropowder silica gel.
Meanwhile, the present invention further discloses described preparation method temperature conditions is 0 ~ 30 DEG C, it is preferred to carry out under the temperature conditions of 20 ~ 28 DEG C.
The disclosed Egelieting oral cavity disintegration tablet smooth surface morphology of the present invention, bright clean, without sliver and sticking, without sliver phenomenon in transport；Simultaneously when clinical practice, in oral cavity, do not need auxiliary drinking-water, it is possible to disintegrate rapidly, without sand type, good mouthfeel.Dissolution in dilute hydrochloric acid solution reaches more than 90%.
And preparation method disclosed in this invention is simple, it is low to consume energy, need not just can produce in a large number by special equipment, applicable industrialized great production.Having production cost low, labor cost is low, it is not necessary to especially or the control of specific condition and monitoring, and industrial applications has good prospects.
Detailed description of the invention
For being further appreciated by the present invention, below in conjunction with implementing technical scheme disclosed in this invention is described in detail, protection scope of the present invention is not limited by the following examples.
Experimental technique described in following example, if no special instructions, is conventional method, involved reagent and material, if no special instructions, is the commercially available prod of commercial sources.
Embodiment 1
Prescription: SYR-322 34g
Lactose 48.5g
Pregelatinized Starch 30g
Microcrystalline Cellulose 18g
L-hydroxypropyl cellulose 15g
Aspartane 1.5g
Micropowder silica gel 1.5g
Water 118.8g
Magnesium stearate 1.5g
Make 1000
Preparation technology: the SYR-322 of the lactose of recipe quantity, pregelatinized Starch, microcrystalline Cellulose, L-hydroxypropyl cellulose, Aspartane and micropowder silica gel and recipe quantity is mixed, add the water granulation of recipe quantity, dry, granulate, it is eventually adding the magnesium stearate mixing of recipe quantity, determine tablet weight and hardness, tabletting, obtains Egelieting oral cavity disintegration tablet.Whole preparation technology completes at 25 DEG C.
Outward appearance: the Egelieting sheet oral cavity disintegration tablet prepared by this law is off-white color, smooth surface morphology.
Ifs vitro disintegration: take prepared Egelieting oral cavity disintegration tablet 1, be placed in the water of 2ml37 DEG C, stands, and complete disintegrate in 37 seconds, whole disintegrate things all can pass through 40 mesh sieves.
Dissolution: taking this Egelieting oral cavity disintegration tablet 6 with the dilute hydrochloric acid of pH2.0 for dissolution medium, detect its dissolution, the dissolution of 15min is 96.5%.(Chinese Pharmacopoeia two annex Ⅹ C the second methods of version in 2010).
Embodiment 2
Prescription: SYR-322 17g
Lactose 65.5g
Pregelatinized Starch 30g
Microcrystalline Cellulose 18g
L-hydroxypropyl cellulose 15g
Aspartane 1.5g
Micropowder silica gel 1.5g
Water 118.8g
Magnesium stearate 1.5g
Make 1000
Preparation technology: the SYR-322 of the lactose of recipe quantity, pregelatinized Starch, microcrystalline Cellulose, L-hydroxypropyl cellulose, Aspartane and micropowder silica gel and recipe quantity is mixed, add the water granulation of recipe quantity, dry, granulate, it is eventually adding the magnesium stearate mixing of recipe quantity, determine tablet weight and hardness, tabletting, obtains Egelieting oral cavity disintegration tablet.Whole preparation technology completes at 25 DEG C.
Outward appearance: the Egelieting sheet oral cavity disintegration tablet prepared by this law is off-white color, smooth surface morphology.
Ifs vitro disintegration: take prepared Egelieting oral cavity disintegration tablet 1, be placed in the water of 2ml37 DEG C, stands, and complete disintegrate in 42 seconds, whole disintegrate things all can pass through 40 mesh sieves.
Dissolution: taking this Egelieting oral cavity disintegration tablet 6 with the dilute hydrochloric acid of pH2.0 for dissolution medium, detect its dissolution, the dissolution of 15min is 94.8%.(Chinese Pharmacopoeia two annex Ⅹ C the second methods of version in 2010).
Embodiment 3
Prescription: SYR-322 8.5g
Lactose 74g
Pregelatinized Starch 30g
Microcrystalline Cellulose 18g
L-hydroxypropyl cellulose 15g
Aspartane 1.5g
Micropowder silica gel 1.5g
Water 118.8g
Magnesium stearate 1.5g
Make 1000
Preparation technology: the SYR-322 of the lactose of recipe quantity, pregelatinized Starch, microcrystalline Cellulose, L-hydroxypropyl cellulose, Aspartane and micropowder silica gel and recipe quantity is mixed, add the water granulation of recipe quantity, dry, granulate, it is eventually adding the magnesium stearate mixing of recipe quantity, determine tablet weight and hardness, tabletting, obtains Egelieting oral cavity disintegration tablet.Whole preparation technology completes at 25 DEG C.
Outward appearance: the Egelieting sheet oral cavity disintegration tablet prepared by this law is off-white color, smooth surface morphology.
Ifs vitro disintegration: take prepared Egelieting oral cavity disintegration tablet 1, be placed in the water of 2ml37 DEG C, stands, and complete disintegrate in 40 seconds, whole disintegrate things all can pass through 40 mesh sieves.
Dissolution: taking this Egelieting oral cavity disintegration tablet 6 with the dilute hydrochloric acid of pH2.0 for dissolution medium, detect its dissolution, the dissolution of 15min is 96.1%.(Chinese Pharmacopoeia two annex Ⅹ C the second methods of version in 2010).
Embodiment 4 Egelieting oral cavity disintegration tablet stability study
Egelieting oral cavity disintegration tablet prepared by example 1 is carried out study on the stability, and result is in Table 1.
Method:
(1) hot test
Take Egelieting oral cavity disintegration tablet and put in the clean container that opening is suitable, place 10 days at 60 DEG C, in sampling in the 5th day and the 10th day, detect by stability high spot reviews project (character, content and have related substance).
(2) high wet test
Take Egelieting oral cavity disintegration tablet and put in the clean container that opening is suitable, place 10 days under 25 DEG C of relative humidity 90 ± 5% conditions, in sampling in the 5th day and the 10th day, detect by stability high spot reviews project (character, content and have related substance).
(3) exposure experiments to light
Take Egelieting oral cavity disintegration tablet and put in the clean container that opening is suitable, place 10 days when 4500 ± 500lx, in sampling in the 5th day and the 10th day, detect by stability high spot reviews project (character, content and have related substance).
Table 1 Egelieting oral cavity disintegration tablet study on the stability result
The comparative efficacy test of embodiment 5 Egelieting oral cavity disintegration tablet and tradition Egelieting tablet
(1) Egelieting oral cavity disintegration tablet and the tradition Egelieting tablet impact on normal rat blood sugar
nullMethod: extracting male Wistar rat 60，Body weight 180g ~ 220g，It is randomly divided into 5 groups by body weight，Often group 12，Respectively blank group，Egelieting sheet low dose group (0.15mg/kg)，Egelieting sheet high dose group (0.3mg/kg)，Egelieting oral cavity disintegration tablet low dose group (0.15mg/kg) and Egelieting oral cavity disintegration tablet high dose group (0.3mg/kg)，Before administration，Rat Fast can't help water 12h，According to 1.0ml/100g body weight，Give distilled water to blank group，Administration group gives tested medicine，At 30min，60min and 180min is in tail vein blood separation serum，Measure serum glucose (SerumGlu) value，Calculate each group of blood glucose meansigma methods and standard deviation，And compare with blank group respectively，Carry out t inspection.
Result: gained Egelieting oral cavity disintegration tablet low dose group of the present invention and Egelieting sheet low dose group all can significantly reduce rat blood sugar value, compares with blank group and has significant difference (P < 0.05).Egelieting oral cavity disintegration tablet high dose group with and Egelieting sheet high dose group all can significantly reduce rat blood sugar value in pole, compare with blank group there is pole significant difference (P < 0.01).(result is in Table 2)
Table 2 Egelieting oral cavity disintegration tablet and the tradition Egelieting tablet impact (X ± D) on normal rat blood sugar
Note: compare with blank group, * P < 0.05, * * P < 0.01
(2) glucose load is caused the impact of hyperglycemic rat by Egelieting oral cavity disintegration tablet and tradition Egelieting tablet
Method: extracting male Wistar rat 60, body weight 180g ~ 220g, it is randomly divided into 5 groups by body weight, often group 12, respectively blank group, Egelieting sheet low dose group, Egelieting sheet high dose group, Egelieting oral cavity disintegration tablet low dose group and Egelieting oral cavity disintegration tablet high dose group, before administration, Rat Fast can't help water 12h, in tail vein blood separation serum, measure 0h serum glucose (SerumGlu) value, administration group gavage gives 1h after glucose, 2h, 3h is respectively at tail vein blood separation serum, measure serum glucose (SerumGlu) value, calculate each group of blood glucose meansigma methods and standard deviation, and compare with blank group respectively, carry out t inspection.
Result: gained Egelieting oral cavity disintegration tablet low dose group of the present invention and Egelieting sheet low dose group all can significantly reduce rat blood sugar value, compares with blank group and has significant difference (P < 0.05).Egelieting oral cavity disintegration tablet high dose group with and Egelieting sheet high dose group all can significantly reduce rat blood sugar value in pole, compare with blank group there is pole significant difference (P < 0.01).(result is in Table 3)
Glucose load is caused the impact (X ± D) of hyperglycemic rat with tradition Egelieting tablet by table 3 Egelieting oral cavity disintegration tablet
Note: compare with blank group, * P < 0.05, * * P < 0.01
Claims (10)
1. an Egelieting oral cavity disintegration tablet, it is characterized in that, described Egelieting oral cavity disintegration tablet is made up of SYR-322 and diluent, binding agent, disintegrating agent, correctives, lubricant and the fluidizer of recipe quantity, and wherein each components by weight is SYR-322 1 ~ 45 part, diluent 1 ~ 85 part, binding agent 20 ~ 95 parts, disintegrating agent 1 ~ 60 part, correctives 0.01 ~ 10 part, lubricant 0.01 ~ 15 part, fluidizer 0.01 ~ 12 part.
2. Egelieting oral cavity disintegration tablet according to claim 1, it is characterized in that, described each components by weight is, SYR-322 4 ~ 30 parts, diluent 10 ~ 60 parts, binding agent 40 ~ 85 parts, disintegrating agent 5 ~ 45 parts, correctives 0.5 ~ 3 part, lubricant 0.5 ~ 3 part, fluidizer 0.5 ~ 3 part.
3. Egelieting oral cavity disintegration tablet according to claim 1 and 2, is characterized in that, described diluent is one or more mixture in pregelatinized Starch, mannitol, lactose, polyvinylpolypyrrolidone.
4. Egelieting oral cavity disintegration tablet according to claim 1 and 2, is characterized in that, described binding agent is water.
5. Egelieting oral cavity disintegration tablet according to claim 1 and 2, is characterized in that, described disintegrating agent is one or more mixture in microcrystalline Cellulose, pregelatinized Starch, polyvinylpolypyrrolidone, L-hydroxypropyl cellulose.
6. Egelieting oral cavity disintegration tablet according to claim 1 and 2, is characterized in that, described correctives is Aspartane and/or cyclamate.
7. Egelieting oral cavity disintegration tablet according to claim 1 and 2, is characterized in that, described lubricant is magnesium stearate and/or Pulvis Talci.
8. Egelieting oral cavity disintegration tablet according to claim 1 and 2, is characterized in that, described fluidizer is micropowder silica gel.
9. the method preparing in claim 1 to 8 Egelieting oral cavity disintegration tablet described in any one, is characterized in that, comprise the following steps,
(1) active ingredient benzoic acid Egelieting being crossed 100 mesh sieves, 80 mesh sieves crossed by other all adjuvants, standby；
(2) diluent of recipe quantity, disintegrating agent, correctives and fluidizer and SYR-322 are mixed, obtain mixture A；
(3) binding agent of recipe quantity is added mixture A to granulate, dry, obtain granule B after granulate；
(4) lubricant is added in granule B, mixing, tabletting, obtain Egelieting oral cavity disintegration tablet.
10. preparation method according to claim 9, is characterized in that, preparation temperature condition is 0 ~ 30 DEG C, it is preferred to 20 ~ 28 DEG C.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115887396A (en) * | 2023-01-06 | 2023-04-04 | 北京中科利华医药研究院有限公司 | Methazolamide orally disintegrating tablet and preparation method and application thereof |
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| CN103877054A (en) * | 2012-12-21 | 2014-06-25 | 北大方正集团有限公司 | Alogliptin benzoate tablet and preparation method thereof |
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- 2014-12-31 CN CN201410845140.9A patent/CN105796514A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103877054A (en) * | 2012-12-21 | 2014-06-25 | 北大方正集团有限公司 | Alogliptin benzoate tablet and preparation method thereof |
| CN103156819A (en) * | 2013-03-29 | 2013-06-19 | 山东罗欣药业股份有限公司 | Benzoic acid alogliptin composition troche and preparation method thereof |
Non-Patent Citations (1)
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| 郭慧玲等主编: "《药剂学》", 28 February 2014, 中山大学出版社 * |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115887396A (en) * | 2023-01-06 | 2023-04-04 | 北京中科利华医药研究院有限公司 | Methazolamide orally disintegrating tablet and preparation method and application thereof |
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Application publication date: 20160727 |