CN106539778A - Preoperative buccal oral cavity effervescent tablet of a kind of pediatric anesthesia and preparation method thereof - Google Patents
Preoperative buccal oral cavity effervescent tablet of a kind of pediatric anesthesia and preparation method thereof Download PDFInfo
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- CN106539778A CN106539778A CN201611119211.2A CN201611119211A CN106539778A CN 106539778 A CN106539778 A CN 106539778A CN 201611119211 A CN201611119211 A CN 201611119211A CN 106539778 A CN106539778 A CN 106539778A
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- effervescent tablet
- oral cavity
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- dexmedetomidine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
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- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
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- Engineering & Computer Science (AREA)
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Abstract
The invention discloses preoperative buccal oral cavity effervescent tablet of a kind of pediatric anesthesia and preparation method thereof, its composition is dexmedetomidine hydrochloride, tartaric acid, sodium acid carbonate, Aspartame, sodium chloride, mannitol, binder and lubricant；Its preparation method is by tartaric acid, sodium acid carbonate, mannitol, Aspartame and sodium chloride, stir in being added to mixer after sieving respectively together, then dexmedetomidine hydrochloride is added in said mixture and is sufficiently stirred for, it is subsequently adding PVP ethanol solutions, softwood is obtained after being sufficiently stirred for, above-mentioned softwood is sieved, is dried and after whole grain, add PEG6000, compressing tablet is carried out after being sufficiently stirred for, is obtained final product.The present invention remarkable result be, for the infant for preparing row operation, downern dexmedetomidine hydrochloride oral transmucosal contained in effervescent tablet is made to absorb rapidly by the form of buccal, calm purpose and breathing is not affected before reaching anesthesia, it is to avoid intramuscular injection or intravenous injection acupuncture are acted on to the bad mental that children bring.
Description
Technical field
The present invention relates to a kind of anaesthetic, the preoperative buccal oral cavity effervescent tablet of specifically a kind of pediatric anesthesia and its system
Preparation Method.
Background technology
The main stream approach of pediatric anesthesia induction is the suction induction of gas anesthesia in the world at present, cannot be real in suction induction
When applying, infant must orally or intramuscular injection some arcotics can just enter operating room and carry out general anaesthesia induction.And it is domestic relative
Fall behind, the scheme that main pediatric anesthesia is induced is intramuscular injection or is injected intravenously downern, and acupuncture can be made to the children for regaining consciousness
Into menticide, increase the incidence of postoperative various complication.
Oral pediatric anesthesia induction formulation mainly has the preparation of all types of syrup mixing sedatives, its administration side both at home and abroad
Formula is the purpose that calmness is reached after oral administration solid or liquid sedative are equipped with a certain amount of water, is taken medicine and part children are received
Degree is poor, drinking-water before the anesthesia induction risk inhaled by mistake of backflowing of may also increase.
Dexmedetomidine hydrochloride is an effective, α for high selectivity2Receptor stimulating agent, with calmness, analgesia, antianxiety,
The effects such as retardance sympathetic nerve, thrifty opioid drug, there is provided unique calm type " retains the calmness of consciousness ", patient
Seem in sleep state, but be easily waken up, can be with examiner's exchange and cooperation；Basic pharmacology and clinical research show hydrochloric acid
Dexmedetomidine oral mucosal absorption bioavilability up to more than 80%, rapid-action, action time is relatively short, short sedation
It is safe；Additionally, it hardly causes respiration inhibition, moreover it is possible to prevention of postoperative n and V and shiver with cold.
The content of the invention
The technical problem to be solved is for above-mentioned deficiency of the prior art, there is provided a kind of pediatric anesthesia
The preoperative oral cavity of dexmedetomidine hydrochloride containing oral dosage form effervescent tablet.
The concrete technical scheme of the present invention is as follows：
A kind of preoperative buccal oral cavity effervescent tablet of pediatric anesthesia, including the raw material of following weight parts：Dexmedetomidine hydrochloride 0.01-
0.06, tartaric acid 100-250, sodium acid carbonate 150-350, Aspartame 2.5-5, sodium chloride 10-20, mannitol 100-250 are dense
Spend the PVP ethanol solution 72.5-262.5 for 10%, PEG6000 10-20.
The present invention also provides a kind of preparation method of the preoperative buccal oral cavity effervescent tablet of above-mentioned pediatric anesthesia, and step is as follows：
（1）Tartaric acid is weighed in proportion, and sodium acid carbonate, Aspartame, sodium chloride, mannitol are crossed 80 mesh sieves respectively, mix, stir
Mix uniform；
（2）Precision measures dexmedetomidine hydrochloride, is added in mixed material obtained by upper step using equal increments method, is stirred
Mix, material is sufficiently mixed uniformly, add 10%PVP ethanol solutions, stir, make softwood；
（3）Softwood made by upper step is made into wet granular, then wet granular is fully dried at 25-30 DEG C, to dried
Particle carries out whole grain, adds PEG6000, is uniformly mixed, and compressing tablet is obtained final product.
As preference：Aforesaid operations are opening indoor air-purifier, room temperature 20-25 DEG C, relative humidity to less than 35%
Under the conditions of carry out.
The present invention by the effervesce agent method in traditional Chinese medicine and pharmacy with it is conventional can oral mucosal absorption anesthetic and sedative drugs hydrochloric acid
Dexmedetomidine carries out use in conjunction.Using soda acid mixing granulation, make effervescent tablet gas release bigger, acidity difference less and steady
Determine, and increased the contact area of Dexmedetomidine and oral mucosa, so as to improve the bioavilability of Dexmedetomidine；Adopt
Dexmedetomidine is made preferably to merge and be evenly distributed with auxiliary material with dexmedetomidine hydrochloride parenteral solution.For preparation row operation
Infant, gives dexmedetomidine hydrochloride oral cavity effervescent tablet buccal by father and mother in operation Accreditation Waiting Area, after the tablet is put into oral cavity, in bubble
In the presence of rising disintegrant tartaric acid and sodium acid carbonate, tablet produces a large amount of bubbles in oral cavity at once, tablet is disintegrated rapidly
And thawing, a large amount of foams produced due to disintegration increased Dexmedetomidine and are directly connect with the more extensive of oral cavity position
Touch so as to preferably play sedation.
Present invention has the advantages that, for the infant for preparing row operation, made in effervescent tablet by the form of buccal contained
Downern dexmedetomidine hydrochloride oral transmucosal absorbs rapidly, reaches the front calm purpose of anesthesia and does not affect breathing, keeps away
Exempt from intramuscular injection or intravenous injection acupuncture to act on to the bad mental that children bring.
Specific embodiment
With reference to embodiment, the present invention will be further described.
Embodiment 1：
Dexmedetomidine hydrochloride oral cavity effervescent tablet, it is composed of the following components：Dexmedetomidine hydrochloride 10-60 μ g, tartaric acid
100mg, sodium acid carbonate 150mg, Aspartame 2.5mg, sodium chloride 10mg, mannitol 100mg, 10%PVP ethanol solutions
72.5mg, PEG6000 10mg.
The method for preparing dexmedetomidine hydrochloride oral cavity effervescent tablet, comprises the following steps：
（1）Indoor air-purifier 1-2 hours are opened, control room temperature controls relative humidity to less than 35% to 20-25 DEG C；
（2）100mg tartaric acid is weighed, 150mg sodium acid carbonates, 2.5mg Aspartames, 10mg sodium chloride, 100mg mannitol divide
60-100 mesh sieves are not crossed, is added in three-dimensional mixer, stir 15-60 minutes；
（3）Precision measures 10-60 μ g dexmedetomidine hydrochlorides, using equal increments method be added to it is mixed above after material in,
Stirring 10-30 minutes, make material be sufficiently mixed the 10%PVP ethanol solutions for uniformly adding 72.5mg, stir 5-20 minutes,
Make softwood.
（4）Softwood made by will be above-mentioned, makes wet granular with the oscillating granulator for being provided with 16-20 mesh sieves, then places
In heated-air circulation oven, 1-3 hours, the dried particle pelletizing machine for being provided with 14-20 mesh sieves are dried at 25-30 DEG C
Whole grain is carried out, the PEG6000 of 10mg is added, is uniformly mixed, compressing tablet.
Embodiment 2：
Dexmedetomidine hydrochloride oral cavity effervescent tablet, it is composed of the following components：Dexmedetomidine hydrochloride 10-60 μ g, tartaric acid
125mg, sodium acid carbonate 175mg, Aspartame 2.5mg, sodium chloride 10mg, mannitol 125mg, 10%PVP ethanol solutions
131.25mg,
PEG6000 10mg。
The method for preparing dexmedetomidine hydrochloride oral cavity effervescent tablet, comprises the following steps：
（1）Indoor air-purifier 1-2 hours are opened, control room temperature controls relative humidity to less than 35% to 20-25 DEG C；
（2）125mg tartaric acid is weighed, 175mg sodium acid carbonates, 2.5mg Aspartames, 10mg sodium chloride, 125mg mannitol divide
60-100 mesh sieves are not crossed, is added in three-dimensional mixer, stir 15-60 minutes；
（3）Precision measures 10-60 μ g dexmedetomidine hydrochlorides, using equal increments method be added to it is mixed above after material in,
Stirring 10-30 minutes, material is made to be sufficiently mixed the 10%PVP ethanol solutions for uniformly adding 131.25mg, 5-20 point of stirring
Clock, makes softwood.
（4）Softwood made by will be above-mentioned, makes wet granular with the oscillating granulator for being provided with 16-20 mesh sieves, then places
In heated-air circulation oven, 1-3 hours, the dried particle pelletizing machine for being provided with 14-20 mesh sieves are dried at 25-30 DEG C
Whole grain is carried out, the PEG6000 of 10mg is added, is uniformly mixed, compressing tablet.
Embodiment 3：
Dexmedetomidine hydrochloride oral cavity effervescent tablet, it is composed of the following components：Dexmedetomidine hydrochloride 10-60 μ g, tartaric acid
200mg, sodium acid carbonate 300mg, Aspartame 5mg, sodium chloride 20mg, mannitol 200mg, 10%PVP ethanol solutions
145mg, PEG6000 20mg.
The method for preparing acid hydrochloride salt Dexmedetomidine oral cavity effervescent tablet, comprises the following steps：
（1）Indoor air-purifier 1-2 hours are opened, control room temperature controls relative humidity to less than 35% to 20-25 DEG C；
（2）Weigh 200mg tartaric acid, 300mg sodium acid carbonates, 5mg Aspartames, 20mg sodium chloride, 200mg mannitol, difference
60-100 mesh sieves are crossed, is added in three-dimensional mixer, stir 15-60 minutes；
（3）Precision measures 10-60 μ g dexmedetomidine hydrochlorides, using equal increments method be added to it is mixed above after material in,
Stirring 10-30 minutes, make material be sufficiently mixed the 10%PVP ethanol solutions for uniformly adding 145mg, stir 5-20 minutes,
Make softwood.
（4）Softwood made by will be above-mentioned, makes wet granular with the oscillating granulator for being provided with 16-20 mesh sieves, then places
In heated-air circulation oven, 1-3 hours, the dried particle pelletizing machine for being provided with 14-20 mesh sieves are dried at 25-30 DEG C
Whole grain is carried out, the PEG6000 of 20mg is added, is uniformly mixed, compressing tablet.
Embodiment 4：
Acid hydrochloride salt Dexmedetomidine oral cavity effervescent tablet, it is composed of the following components：Dexmedetomidine hydrochloride 10-60 μ g, tartaric acid
250mg, sodium acid carbonate 350mg, Aspartame 5mg, sodium chloride 20mg, mannitol 250mg, 10%PVP ethanol solutions
262.5mg, PEG6000 20mg.
The method for preparing acid hydrochloride salt Dexmedetomidine oral cavity effervescent tablet, comprises the following steps：
（1）Indoor air-purifier 1-2 hours are opened, control room temperature controls relative humidity to less than 35% to 20-25 DEG C；
（2）Weigh 250mg tartaric acid, 350mg sodium acid carbonates, 5mg Aspartames, 20mg sodium chloride, 250mg mannitol, difference
60-100 mesh sieves are crossed, is added in three-dimensional mixer, stir 15-60 minutes；
（3）Precision measures 10-60 μ g dexmedetomidine hydrochlorides, using equal increments method be added to it is mixed above after material in,
Stirring 10-30 minutes, material is made to be sufficiently mixed the 10%PVP ethanol solutions for uniformly adding 262.5mg, 5-20 point of stirring
Clock, makes softwood.
（4）Softwood made by will be above-mentioned, makes wet granular with the oscillating granulator for being provided with 16-20 mesh sieves, then places
In heated-air circulation oven, 1-3 hours, the dried particle pelletizing machine for being provided with 14-20 mesh sieves are dried at 25-30 DEG C
Whole grain is carried out, the PEG6000 of 20mg is added, is uniformly mixed, compressing tablet.
Dexmedetomidine hydrochloride oral cavity effervescent tablet prepared by the present invention, for the infant for preparing row operation, by the form of buccal
The downern dexmedetomidine hydrochloride oral transmucosal contained by effervescent tablet is absorbed rapidly, reach before anesthesia calm purpose and
Do not affect breathing, it is to avoid intramuscular injection or intravenous injection acupuncture are acted on to the bad mental that children bring.
Preoperative calmness dexmedetomidine hydrochloride containing the formulation oral cavity effervescent tablet of pediatric anesthesia manufactured in the present embodiment be divided into
Lower grade：
Without pharmaceutically dosage form：Suitable for doctor or father and mother's buccal, to guide children's buccal；
10 μ g (content of Dexmedetomidine in every formulation)：The children of 5kg are less than or equal to suitable for body weight；
20 μ g (content of Dexmedetomidine in every formulation)：The children of 10kg are less than or equal to more than 5kg suitable for body weight；
30 μ g (content of Dexmedetomidine in every formulation)：The children of 15kg are less than or equal to more than 10kg suitable for body weight；
40 μ g (content of Dexmedetomidine in every formulation)：The children of 20kg are less than or equal to more than 15kg suitable for body weight；
60 μ g (content of Dexmedetomidine in every formulation)：It is more than the children of 20kg suitable for body weight.
It should be appreciated that the part that this specification is not elaborated belongs to prior art.
It should be appreciated that the above-mentioned description for preferred embodiment is more detailed, therefore can not be considered to the present invention
The restriction of scope of patent protection, one of ordinary skill in the art are being wanted without departing from right of the present invention under the enlightenment of the present invention
Ask under protected ambit, replacement can also be made or deformed, be each fallen within protection scope of the present invention, it is of the invention
Scope is claimed to be defined by claims.
Claims (3)
1. the preoperative buccal oral cavity effervescent tablet of a kind of pediatric anesthesia, it is characterised in that：Including the raw material of following weight parts：The right U.S. of hydrochloric acid
Support miaow determines 0.01-0.06, tartaric acid 100-250, sodium acid carbonate 150-350, Aspartame 2.5-5, sodium chloride 10-20, sweet dew
Alcohol 100-250, concentration are 10% PVP ethanol solution 72.5-262.5, PEG6000 10-20.
2. the preparation method of the preoperative buccal oral cavity effervescent tablet of a kind of pediatric anesthesia as claimed in claim 1, it is characterised in that：Step
It is as follows：
（1）Tartaric acid is weighed in proportion, and sodium acid carbonate, Aspartame, sodium chloride, mannitol are crossed 80 mesh sieves respectively, mix, stir
Mix uniform；
（2）Precision measures dexmedetomidine hydrochloride, is added in mixed material obtained by upper step using equal increments method, is stirred
Mix, material is sufficiently mixed uniformly, add 10%PVP ethanol solutions, stir, make softwood；
（3）Softwood made by upper step is made into wet granular, then wet granular is fully dried at 25-30 DEG C, to dried
Particle carries out whole grain, adds PEG6000, is uniformly mixed, and compressing tablet is obtained final product.
3. preparation method as claimed in claim 2, it is characterised in that：Aforesaid operations are opening indoor air-purifier, room temperature 20-
25 DEG C, relative humidity below 35% under conditions of carry out.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611119211.2A CN106539778A (en) | 2016-12-08 | 2016-12-08 | Preoperative buccal oral cavity effervescent tablet of a kind of pediatric anesthesia and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611119211.2A CN106539778A (en) | 2016-12-08 | 2016-12-08 | Preoperative buccal oral cavity effervescent tablet of a kind of pediatric anesthesia and preparation method thereof |
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| CN106539778A true CN106539778A (en) | 2017-03-29 |
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| CN201611119211.2A Pending CN106539778A (en) | 2016-12-08 | 2016-12-08 | Preoperative buccal oral cavity effervescent tablet of a kind of pediatric anesthesia and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106727443A (en) * | 2016-12-08 | 2017-05-31 | 武汉大学 | Preoperative calm stealthy nose paste preparation of a kind of pediatric anesthesia and preparation method thereof |
| NO20171457A1 (en) * | 2016-12-20 | 2018-06-21 | X Ing As | Effervescent lozenge |
| US10792246B2 (en) | 2018-06-27 | 2020-10-06 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11786508B2 (en) | 2016-12-31 | 2023-10-17 | Bioxcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| US11806334B1 (en) | 2023-01-12 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US11890272B2 (en) | 2019-07-19 | 2024-02-06 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
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| CN103957906A (en) * | 2011-10-14 | 2014-07-30 | 赫思公司 | Methods of treating pediatric patients using dexmedetomidine |
| CN104434863A (en) * | 2014-11-13 | 2015-03-25 | 武汉大学 | Tetracaine hydrochloride oral effervescent tablet and preparation method thereof |
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Patent Citations (2)
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| CN103957906A (en) * | 2011-10-14 | 2014-07-30 | 赫思公司 | Methods of treating pediatric patients using dexmedetomidine |
| CN104434863A (en) * | 2014-11-13 | 2015-03-25 | 武汉大学 | Tetracaine hydrochloride oral effervescent tablet and preparation method thereof |
Non-Patent Citations (1)
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Cited By (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106727443A (en) * | 2016-12-08 | 2017-05-31 | 武汉大学 | Preoperative calm stealthy nose paste preparation of a kind of pediatric anesthesia and preparation method thereof |
| NO20171457A1 (en) * | 2016-12-20 | 2018-06-21 | X Ing As | Effervescent lozenge |
| US11931340B2 (en) | 2016-12-31 | 2024-03-19 | Bioxcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| US11839604B2 (en) | 2016-12-31 | 2023-12-12 | Bioxcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| US11786508B2 (en) | 2016-12-31 | 2023-10-17 | Bioxcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| US11559484B2 (en) | 2018-06-27 | 2023-01-24 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11517524B2 (en) | 2018-06-27 | 2022-12-06 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11497711B2 (en) | 2018-06-27 | 2022-11-15 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11806429B2 (en) | 2018-06-27 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11478422B2 (en) | 2018-06-27 | 2022-10-25 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US10792246B2 (en) | 2018-06-27 | 2020-10-06 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11890272B2 (en) | 2019-07-19 | 2024-02-06 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US11998529B2 (en) | 2019-07-19 | 2024-06-04 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US11806334B1 (en) | 2023-01-12 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US11998528B1 (en) | 2023-01-12 | 2024-06-04 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
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