CN102727456A - Orally disintegrating tablet of poorly water-soluble drugs and method for preparing orally disintegrating tablet - Google Patents
Orally disintegrating tablet of poorly water-soluble drugs and method for preparing orally disintegrating tablet Download PDFInfo
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- CN102727456A CN102727456A CN2012102362629A CN201210236262A CN102727456A CN 102727456 A CN102727456 A CN 102727456A CN 2012102362629 A CN2012102362629 A CN 2012102362629A CN 201210236262 A CN201210236262 A CN 201210236262A CN 102727456 A CN102727456 A CN 102727456A
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Abstract
The invention relates to an orally disintegrating tablet preparation which can quickly release drugs and has a good taste, and in particular relates to a prescription and a preparation method which are designed for poorly water-soluble drugs. The method for preparing the orally disintegrating tablet comprises the steps that the drugs and all the adjuvants are sequentially subjected to spray-drying treatment in a same container, so the powdery or microparticle mixture is obtained. Because a layering spray-drying mode is adopted, part coating function is played and the disintegration is quick, the exposed drug parts can be dissolved at first, and then the coating parts and the core parts are sequentially dissolved, so a better concentration gradient is formed, and the drugs can be fully absorbed. Consequently, the quick disintegration and dissolution of the drugs can be realized without using the effervescing agent or using a small amount of the effervescing agent.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of have rapid delivery of pharmaceuticals and the good orally disintegrating tablet preparation of taste, is prescription and the method for preparing that designs for insoluble drug specifically.
Background technology
Oral cavity disintegration tablet is a kind of new oral dosage form.Disintegrate fast in the oral cavity that such preparation can be under anhydrous condition (or only having low amounts of water to exist) gets into digestive tract with swallowing act, in the oral cavity, does not have mucosa absorption, and absorption in the body, metabolic process are consistent with conventional tablet.According to estimates, there is 50% people that swallow tablet and capsule are had any problem approximately, influenced the compliance of Drug therapy.In department of pediatrics and old medicine and pharmacology field, in water, dissolving or suspend, can chew or can in mouth, very big demand being arranged rapid dissolved solid preparation.
The ultimate challenge of developing instant is exactly that the physical property and the disintegrating property of tablet all wants good.Italy Eurand company has developed Ziple ts technology, applicable to water-insoluble drug.This technology mainly is that adopt to add an amount of inorganic adjuvant of water-insoluble and effervescent combined, even under all lower situation of compression force and tablet hardness, instant also can have good physical property and disintegrating property simultaneously.Yet adopting the water-insoluble materials of larger proportion is to be easy to generate grittiness; Cause and take constantly, simultaneously the flavored action of effervescent is limited, and this is because effervescent need just can play effect under water function; And, take all factors into consideration the disintegrate and the medicine dissolution needs of whole tablet for oral environment, should not use in a large number; And more after a little while, can't produce sufficient bubble again and play the effect of covering poor taste.
Summary of the invention
The objective of the invention is to improve the deficiency of existing insoluble drug oral cavity disintegration tablet, a kind of taking convenience is provided, absorbs rapid-action, good mouthfeel and the high insoluble drug orally disintegrating tablet preparation of bioavailability.
The insoluble drug oral cavity disintegration tablet that reaches according to the invention, according to weight ratio, insoluble drug 5-50%, binding agent 1-10%, filler 20-90%, disintegrating agent 5-45%, effervescent 0-30%, fluidizer 0-5%, lubricant 0-3%.
The insoluble drug oral cavity disintegration tablet of further being addressed, according to weight ratio, insoluble drug 10-20%, binding agent 3-5%, filler 40-90%, disintegrating agent 10-40%, effervescent 0-30% also can comprise fluidizer 0-5%, lubricant 0-3%.
Further, above-mentioned insoluble drug oral cavity disintegration tablet, according to weight ratio, effervescent 5-20% also can comprise fluidizer 3-5%, lubricant 1-3%.
Wherein, Binding agent includes but are not limited to day hot glue family macromolecule polymer such as starch, pregelatinized Starch, dextrin, maltodextrin, sucrose, arabic gum or gelatin, hydrophilic cellulose base polymer, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone (PVP), alginic acid and alginate, xanthan gum, hydroxypropyl cellulose and hydroxypropyl emthylcellulose (HPMC); Can use use also capable of being combined separately.Be preferably polyvinylpyrrolidone (PVP), arabic gum, gelatin, hypromellose.
Filler is tasteless or sweet cpd; Include but are not limited to mannitol, xylitol, sorbitol, maltose 、 Chi ?alcohol, microcrystalline Cellulose,
SMCC, polymerization sugar
coupling sugar, glucose, lactose, sucrose, dextrin and starch etc.; Can use separately, also can Combination application.Be preferably mannitol, xylitol, sorbitol.
Disintegrating agent includes but are not limited to crospolyvinylpyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), low substituted hydroxy-propyl methylcellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa) and soybean polysaccharide
etc.; Can use use also capable of being combined separately.Be preferably crospolyvinylpyrrolidone (PVPP).
Fluidizer includes but are not limited to micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, hydrated sodium aluminosilicate.Lubricant includes but are not limited to magnesium stearate, calcium stearate, zinc stearate, glyceryl monostearate, Polyethylene Glycol, hydrogenated vegetable oil, sodium stearyl fumarate, polyoxyethylene monostearate, single Laurel sucrose acid ester, sodium laurylsulfate, lauryl alcohol sulphuric acid younger sister, Stepanol MG and Pulvis Talci etc.; Can use use also capable of being combined separately.
Effervescent includes but are not limited to the mixture of malic acid, citric acid or citric acid and sodium bicarbonate or sodium carbonate.
Above-mentioned oral cavity disintegration tablet, it promptly carries out spray drying treatment with medicine, each adjuvant successively through special method for preparing in same container, obtain being mixture Powdered or the microparticle shape.Except fluidizer and lubricant, the adjuvant of all the other kinds, for example binding agent, filler, disintegrating agent, three's order can change arbitrarily or or will wherein a kind ofly join in other two kinds with arbitrary proportion.Also can take same processing when increasing other kind adjuvants.
Concrete method for preparing comprises:
1. with medicine, filler, disintegrating agent mixed dissolution in solvent, be called solution 1 respectively, solution 2, solution 3.
2. solution 1 is carried out spray drying in fluid bed or spray dryer earlier, make medicine be " boiling " state after, spray into solution 2 and solution 3 more successively, drying obtains being solids Powdered or the microparticle shape.
3. with the 2. the solids that obtains of step mix, mix direct compression or granulation with other adjuvants.
Need to prove that the order that above-mentioned solution 2 and 3 sprays into is unrestricted, only need spray into successively.Preferably, spray into disintegrating agent solution 3 at last.
Preferably, above-mentioned method for preparing can be divided equally disintegrating agent equivalent or arbitrary proportion is dissolved in each solution, in the ie in solution 1 and 2, and refabrication solution 3 not.
Preferably, above-mentioned method for preparing can with the part adhesive be dissolved in the solvent form solution 4 after, the 2. in the step, spray into after solution 1 makes medicine be " boiling " state spraying into.Can also equivalent or arbitrary proportion be dissolved in the solution 2,3 and spray into together.
Likewise, above-mentioned method for preparing is treated to spray into after medication medication is " boiling " state after also can also can taking said method to form solution 5 correctives, can also equivalent or arbitrary proportion be dissolved in solution 2,3, spray into together in 4.
Different with common spray drying is that the present invention comprises disintegrating agent with medicine and main adjuvant, after binding agent, filler etc. get into spray drying successively, can cover the bad of medicine better and ask that simultaneously, disintegrate is rapid.Also disintegrate fast under the situation that does not need effervescent.
Preferably; Having under the situation of effervescent; Add in 3. in above-mentioned steps, perhaps one of them adds in the solution with equivalent or arbitrary proportion with acid moieties/alkali part in 2. in step, and remaining alkali part/acid moieties mixes perhaps tabletting after the granulation of back direct compression with other adjuvants.Owing to adopt the spray-dired mode of layering, when the effect of part coating is arranged and disintegrate rapid, and the dissolving that can take the lead in of exposed drug moiety is followed successively by the coating part, the core is thought of as Concentraton gradient preferably, making it medicine can fully be absorbed.Therefore, inapplicable effervescent perhaps uses a small amount of effervescent just can realize the quick disintegrate stripping of medicine.
Need explanatorily be when taking pelletizing press sheet technology, when selecting fluidizer, lubricant are arranged, after granulation, to add.Preferably, prescription is formed, and according to weight ratio is:
Wherein, above-mentioned adjuvant can use preferred other adjuvants to replace.
Above-mentioned oral cavity disintegration tablet, its preparation method comprises:
1. insoluble drug, filler, disintegrating agent, binding agent are dissolved in respectively in the solvent, are called solution A 1 respectively, solution A 2, solution A 3.
2. solution A 1 is carried out spray drying earlier, make medicine be " boiling " state after, spray into solution A 2 and solution A 3 more successively, drying obtains being solids Powdered or the microparticle shape.
3. with the 2. the solids that obtains of step mix, mix direct compression with other adjuvants.Further, prescription is formed, and according to weight ratio is:
Wherein, above-mentioned adjuvant can use preferred other adjuvants to replace.
Above-mentioned oral cavity disintegration tablet, its preparation method comprises:
1. insoluble drug, filler, disintegrating agent, binding agent are dissolved in respectively in the solvent, are called solution A 1 respectively, solution A 2, solution A 3.Simultaneously, one of them is dissolved in solution A 2 or A3 with citric acid/sodium bicarbonate, perhaps is dissolved in solution A 2 and A3 behind the five equilibrium.
2. solution A 1 is carried out spray drying earlier, make medicine be " boiling " state after, spray into solution A 2 and solution A 3 more successively, drying obtains being solids Powdered or the microparticle shape.
3. with the 2. the solids that obtains of step mix, mix direct compression with other adjuvants.
In the present invention, related solvent promptly makes to be not limited to particular types by dissolved solvents such as medicine, adjuvant, as long as make that chemical compound can good solvent, can select organic solvent, and for example acetone, ethanol etc. also can be selected water.
Insoluble drug of the present invention is not limited to the field of specifically treating, and is not limited to certain compounds structure, and only the dissolution properties to medicine has requirement.
The specific embodiment
Below come further to explain or explanation content of the present invention through embodiment.Described embodiment has been merely and has helped to understand content of the present invention, should not be understood that the qualification to purport of the present invention and protection domain.
Drug release determination method of the present invention is release medium referring to two appendix of Chinese Pharmacopoeia version in 2010 with water.
Embodiment 1
Prescription is formed, and according to weight ratio is:
Method for preparing comprises:
1. insoluble drug, binder/disintegrant, filler are dissolved in 95% ethanol, are called solution B 1 respectively, solution B 2, solution B 3.
2. solution B 1 is carried out spray drying earlier, make medicine be " boiling " state after, spray into solution B 2 and solution B 3 more successively, drying obtains being solids Powdered or the microparticle shape.
3. with the 2. the solids that obtains of step mix, mix direct compression after the intermediate content detection with magnesium stearate.
Embodiment 2
Prescription is formed, and according to weight ratio is:
Method for preparing comprises:
1. insoluble drug, binding agent, disintegrating agent/filler are dissolved in the acetone solvent, are called solution C 1 respectively, solution C 2, solution C 3.
2. solution C 1 is carried out spray drying earlier, make medicine be " boiling " state after, spray into solution C 2 and solution C 3 more successively, drying obtains being solids Powdered or the microparticle shape.
3. with the 2. the solids that obtains of step mix, after the intermediate content detection, mix direct compression with magnesium stearate.
Embodiment 3
Prescription is formed, and according to weight ratio is:
Method for preparing comprises:
1. insoluble drug, binding agent, filler are dissolved in the acetone, are called solution D 1 respectively, solution D 2, solution D 3 adds solution D 2 respectively with branches such as disintegrating agents, solution D 3.
2. solution D 1 is carried out spray drying earlier, make medicine be " boiling " state after, spray into solution D 2 and solution D 3 more successively, drying obtains being solids Powdered or the microparticle shape.
3. with the 2. the solids that obtains of step mix, granulate, 50 ℃ of dryings are crossed 20 mesh sieves, after the intermediate content detection, mix tabletting with magnesium stearate.
Embodiment 4
Prescription is formed, and according to weight ratio is:
Method for preparing comprises:
1. insoluble drug, binding agent, filler are dissolved in the acetone, are called solution E 1 respectively, solution E 2, solution E 3 adds solution E 2 respectively, solution E 3 with disintegrating agent and one of them five equilibrium of citric acid/sodium bicarbonate.
2. solution E 1 is carried out spray drying earlier, make medicine be " boiling " state after, spray into solution E 2 and solution E 3 more successively, drying obtains being solids Powdered or the microparticle shape.
3. with the 2. after the solids that obtains of step and the residue adjuvant mixing intermediate content detection, mix tabletting with magnesium stearate.
The foregoing description sample is detected: place 2ml water, measure complete disintegration time and mouthfeel.See following table for details.
The disintegration time of each embodiment insoluble drug of table 1
What need explanation is that above embodiment is just to illustrating the present invention.Under the prerequisite that does not depart from spirit of the present invention and essence, those skilled in the art can design multiple alternative of the present invention and improvement project, and it all should be understood to be within protection scope of the present invention.
Claims (10)
1. the oral cavity disintegration tablet of an insoluble drug, according to weight ratio, tadalafil and pharmaceutically-acceptable salts 5-50% thereof; Binding agent 1-10%, filler 20-90%, disintegrating agent 5-45%; Fluidizer 0-5%, lubricant 0-3%, wherein; In same container, medicine, binding agent, filler, disintegrating agent are carried out spray drying treatment successively, obtain being mixture Powdered or the microparticle shape.
2. the described oral cavity disintegration tablet of claim 1, according to weight ratio, tadalafil and pharmaceutically-acceptable salts 10-20% thereof, binding agent 3-5%, filler 40-90%, disintegrating agent 10-40%, fluidizer 0-5%, lubricant 0-3%.
3. claim 1 or 2 described oral cavity disintegration tablets according to weight ratio, also can comprise effervescent 5-20%.
4. like each described oral cavity disintegration tablet of claim 1-3; Said binding agent is selected from day hot glue family macromolecule polymer such as starch, pregelatinized Starch, dextrin, maltodextrin, sucrose, arabic gum or gelatin, hydrophilic cellulose base polymer, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone (PVP), alginic acid and alginate, xanthan gum, hydroxypropyl cellulose and hydroxypropyl emthylcellulose (HPMC); Can use use also capable of being combined separately; Filler is tasteless or sweet cpd; Include but are not limited to mannitol, xylitol, sorbitol, maltose 、 Chi ?alcohol, microcrystalline Cellulose,
SMCC, polymerization sugar
coupling sugar, glucose, lactose, sucrose, dextrin and starch; Can use separately, also can Combination application; Disintegrating agent selects crospolyvinylpyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), low substituted hydroxy-propyl methylcellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa) and soybean polysaccharide
can use use also capable of being combined separately; Fluidizer is selected from micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, hydrated sodium aluminosilicate; Lubricant is selected from magnesium stearate, calcium stearate, zinc stearate, glyceryl monostearate, Polyethylene Glycol, hydrogenated vegetable oil, sodium stearyl fumarate, polyoxyethylene monostearate, single Laurel sucrose acid ester, sodium laurylsulfate, lauryl alcohol sulphuric acid younger sister, Stepanol MG and Pulvis Talci; Can use use also capable of being combined separately.
5. the described oral cavity disintegration tablet of claim 4, binding agent is polyvinylpyrrolidone (PVP), arabic gum, gelatin, hypromellose; Filler is mannitol, xylitol, sorbitol; Disintegrating agent is crospolyvinylpyrrolidone (PVPP); Lubricant is magnesium stearate, calcium stearate.
6. the described oral cavity disintegration tablet of claim 3, effervescent includes but are not limited to the mixture of malic acid, citric acid or citric acid and sodium bicarbonate or sodium carbonate.
7. the described oral cavity disintegration tablet of claim 1-5 is write out a prescription and is formed, and according to weight ratio is:
Medicine 15-20%,
Binding agent and disintegrating agent polyvinylpyrrolidone (PVP) 10-15%,
Filler mannitol 40-80%,
Fluidizer magnesium stearate 1-2%.
8. the oral cavity disintegration tablet of claim 3 or 6 said tadalafils and pharmaceutically-acceptable salts thereof is write out a prescription and is formed, and according to weight ratio is:
9. the method for preparing of the said oral cavity disintegration tablet of claim 1-8 comprises:
1. with medicine, filler, disintegrating agent mixed dissolution in solvent, be called solution 1 respectively, solution 2, solution 3;
2. solution 1 is carried out spray drying earlier, make medicine be " boiling " state after, spray into solution 2 and solution 3 more successively, drying obtains being solids Powdered or the microparticle shape;
3. with the 2. the solids that obtains of step mix, mixes the direct compression or the tabletting afterwards of granulating with other adjuvants;
Wherein, above-mentioned steps 2. in, solution 2 and 3 the order that sprays into are unrestricted, and only are to spray into successively;
Perhaps, step 1. in, disintegrating agent equivalent is divided equally or arbitrary proportion is dissolved in each solution, in the ie in solution 1 and 2, and refabrication solution 3 not.
10. like the method for preparing of the said oral cavity disintegration tablet of claim 9; The part adhesive is dissolved in formation solution 4 in the solvent; The 2. in the step, after making medicine be " boiling " state, solution 1 sprays into or equivalent or arbitrary proportion are dissolved in and spray into together in the solution 2,3 spraying into;
Likewise, above-mentioned method for preparing is treated to spray into after medication medication is " boiling " state after also can also can taking said method to form solution 5 correctives, can also equivalent or arbitrary proportion be dissolved in solution 2,3, spray into together in 4.
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| CN201210236262.9A CN102727456B (en) | 2012-07-03 | 2012-07-03 | Drug port cavity disintegrating tablet and preparation method thereof |
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| CN102727456A true CN102727456A (en) | 2012-10-17 |
| CN102727456B CN102727456B (en) | 2016-06-22 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103271885A (en) * | 2013-05-23 | 2013-09-04 | 浙江华海药业股份有限公司 | Tadalafil orally disintegrating tablet and preparation method thereof |
| CN105213333A (en) * | 2014-06-30 | 2016-01-06 | 深圳海王药业有限公司 | A kind of tadanafil pharmaceutical composition and preparation method thereof |
| CN112022827A (en) * | 2020-09-30 | 2020-12-04 | 上海信谊天平药业有限公司 | Cyproheptadine hydrochloride quick-release pharmaceutical preparation and preparation method thereof |
| CN114392240A (en) * | 2022-01-20 | 2022-04-26 | 北京微智瑞医药科技有限公司 | Vitamin C orally disintegrating micro-tablets and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101193638A (en) * | 2005-04-13 | 2008-06-04 | 拜耳医药保健股份公司 | Therapeutic combination in case of benign prostate hyperplasia |
| WO2011030351A2 (en) * | 2009-09-03 | 2011-03-17 | Rubicon Research Private Limited | Taste - masked pharmaceutical compositions |
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2012
- 2012-07-03 CN CN201210236262.9A patent/CN102727456B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101193638A (en) * | 2005-04-13 | 2008-06-04 | 拜耳医药保健股份公司 | Therapeutic combination in case of benign prostate hyperplasia |
| WO2011030351A2 (en) * | 2009-09-03 | 2011-03-17 | Rubicon Research Private Limited | Taste - masked pharmaceutical compositions |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103271885A (en) * | 2013-05-23 | 2013-09-04 | 浙江华海药业股份有限公司 | Tadalafil orally disintegrating tablet and preparation method thereof |
| CN105213333A (en) * | 2014-06-30 | 2016-01-06 | 深圳海王药业有限公司 | A kind of tadanafil pharmaceutical composition and preparation method thereof |
| CN112022827A (en) * | 2020-09-30 | 2020-12-04 | 上海信谊天平药业有限公司 | Cyproheptadine hydrochloride quick-release pharmaceutical preparation and preparation method thereof |
| CN114392240A (en) * | 2022-01-20 | 2022-04-26 | 北京微智瑞医药科技有限公司 | Vitamin C orally disintegrating micro-tablets and preparation method thereof |
| CN114392240B (en) * | 2022-01-20 | 2023-12-19 | 北京微智瑞医药科技有限公司 | Vitamin C orally disintegrating micro-tablet and preparation method thereof |
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| CN102727456B (en) | 2016-06-22 |
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