CN111437247A - Preparation method of tomoxetine oral liquid - Google Patents
Preparation method of tomoxetine oral liquid Download PDFInfo
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- CN111437247A CN111437247A CN201910044558.2A CN201910044558A CN111437247A CN 111437247 A CN111437247 A CN 111437247A CN 201910044558 A CN201910044558 A CN 201910044558A CN 111437247 A CN111437247 A CN 111437247A
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- tomoxetine
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- oral liquid
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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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
Abstract
The invention belongs to the technical field of medicines, and particularly relates to an oral solution of tomoxetine and its salt and a preparation method thereof. The oral solution of tomoxetine and the salt thereof prepared by the invention has the following advantages: 1. compared with the common solid preparation, the oral liquid improves the problem of dysphagia of patients, is convenient to take, reduces the bitter taste of the tomoxetine by optimizing the prescription process, has good taste, and obviously improves the medication compliance of children patients; 2. the oral liquid obtained by the invention does not contain preservative and has enough physical and chemical stability and microbial stability, thereby avoiding a series of toxic effects caused by using the preservative and ensuring the safety of medication.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a preparation method of tomoxetine oral liquid.
Background
In 1902, George historian (George Still) doctors published articles in british journal of medicine, and put forward the concept of "Attention Deficit Hyperactivity Disorder (ADHD)" in children for the first time, where ADHD is a common behavior Disorder in children and the cause of the disease is caused by the imbalance of monoamine neurotransmitters in children's brain. If the patient is not treated in time, various symptoms can be caused to accompany the growth of children, and the adverse phenomena of poor self-esteem, lack of confidence, seriously unstable mood, depression, schizophrenia, conduct disorder, antisocial personality and the like can be caused.
Tomoxetine, the first non-excitatory drug approved for the treatment of hyperactivity, increases the amount of norepinephrine and dopamine in the body for the purpose of treating ADHD infants.
Tomoxetine, a selective norepinephrine reuptake inhibitor, is highly selective for the norepinephrine transporter compared with other stimulant drugs, increases the norepinephrine level in the subcortical region without changing the dopamine concentration level in the subcortical region, does not affect the extracellular dopamine level in the striatum and limbic nucleus regions rich in dopamine neurotransmitter distribution, and can reduce the side effects of drugs which cause tic and psychomimetic symptoms.
The oral solution can be taken according to the medication requirements of different children patients, so that the toxic and side effects caused by poor control of the medicine dosage are avoided. Meanwhile, the oral liquid does not contain preservative and has enough physical and chemical stability and microbial stability, thereby avoiding a series of toxic effects caused by using the preservative and ensuring the medication safety.
Disclosure of Invention
The oral liquid has enough physical and chemical stability and microbial stability, avoids a series of toxic effects caused by using the preservative, and particularly ensures the medication safety for children medication patients.
The tomoxetine oral liquid comprises the following components: tomoxetine, an acid-base modifier, a flavoring agent, a stabilizer, a thickening agent, and water.
The tomoxetine oral liquid is characterized by any one or more of the following:
(1) the amount of tomoxetine in each 100ml is 100-3000 mg, such as 100-1000 mg, such as 150-1500 mg, such as 200-2500 mg;
(2) wherein the pH regulator is selected from: citric acid, tartaric acid, malic acid, maleic acid, sorbic acid, sodium citrate, sodium tartrate, and the like, and combinations thereof;
(3) wherein the amount of the acid-base modifier is an amount which brings the pH value of the obtained solution to within a range of 2.0 to 6.0, for example, an amount which brings the pH value to within a range of 3.0 to 5.0, for example, an amount which brings the pH value to within a range of 3.5 to 4.5;
(4) wherein the flavoring agent is selected from: xylitol, sorbitol, maltol, aspartame, acesulfame-k flavors such as water-soluble flavors (e.g., strawberry flavor, orange flavor, pineapple flavor, apple flavor, peppermint flavor, lemon flavor, chocolate flavor, etc.), and the like, and combinations thereof;
(5) the amount of the flavoring agent in each 100ml of the oral solution is 1-5000 mg, such as 5-2000 mg, such as 5-1000 mg;
(6) the tomoxetine oral liquid of claim 1, wherein the antioxidant is selected from the group consisting of sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, vitamin C, and the amount of the oral antioxidant of the present invention is not more than 100mg per 100m L;
the tomoxetine oral solution provided by the invention is characterized by any one or more of the following:
(1) wherein a polyhydric alcohol selected from the group consisting of: glycerin, propylene glycol, and combinations thereof;
(2) the amount of the polyhydric alcohol contained in each 100ml of the tomoxetine oral solution can be 0-1000 mg, for example, 10-100 mg;
the method for preparing the tomoxetine oral solution in any one of the above embodiments of the present invention comprises the following steps:
(1) adding xylitol into water accounting for about 80% of the prescription amount, slightly heating, stirring to dissolve, and uniformly mixing tomoxetine, a flavoring agent and optional other auxiliary materials to obtain a solution I;
(2) adding an acid-base regulator into the obtained solution II and monitoring the pH value of the solution to enable the pH value to reach the pH value range specified by the prescription;
(3) adding water to full dose, comparing the pH value of the test solution, and adding acid-base regulator if necessary to make the solution reach the pH value range specified by the prescription.
Detailed Description
For better understanding of the present invention, the technical solution of the present invention will be described in detail below using specific examples, but it is obvious that the method of implementing the present invention is not limited thereto.
Example 1Tomoxetine oral liquidPreparation of
The prescription composition is as follows:
tomoxetine100mg，
Citric acid 200mg (pH of the final liquid medicine is 4.01),
15g of xylitol is added into the mixture,
100mg of sodium citrate, namely sodium citrate,
100mg of the vitamin C and the vitamin C,
water, appropriate amount added to 100 ml.
The preparation process comprises the following steps:
(1) adding xylitol into water accounting for about 80% of the prescription amount, slightly heating, stirring to dissolve, and uniformly mixing tomoxetine, a flavoring agent and optional other auxiliary materials to obtain a solution I;
(2) adding an acid-base regulator into the obtained solution II and monitoring the pH value of the solution to enable the pH value to reach the pH value range specified by the prescription;
(3) adding water to full dose, comparing the pH value of the test solution, and adding acid-base regulator if necessary to make the solution reach the pH value range specified by the prescription.
Example 2Tomoxetine oral liquidPreparation of
The prescription composition is as follows:
tomoxetine200mg，
Citric acid 200mg (pH of the final liquid medicine is 4.01),
20g of xylitol, namely 20g of xylitol,
100mg of sodium citrate, namely sodium citrate,
100mg of the vitamin C and the vitamin C,
10mg of orange essence is added into the mixture,
water, appropriate amount added to 100 ml.
The preparation process comprises the following steps:
(1) adding xylitol into water accounting for about 80% of the prescription amount, slightly heating, stirring to dissolve, and uniformly mixing tomoxetine, a flavoring agent and optional other auxiliary materials to obtain a solution I;
(2) adding an acid-base regulator into the obtained solution II and monitoring the pH value of the solution to enable the pH value to reach the pH value range specified by the prescription;
(3) adding water to full dose, comparing the pH value of the test solution, and adding acid-base regulator if necessary to make the solution reach the pH value range specified by the prescription.
Example 3Tomoxetine oral liquidPreparation of
The prescription composition is as follows:
tomoxetine300mg，
Citric acid 200mg (pH of the final liquid medicine is 4.01),
20g of xylitol, namely 20g of xylitol,
sorbitol 5g
100mg of sodium citrate, namely sodium citrate,
100mg of the vitamin C and the vitamin C,
10mg of the strawberry essence is added into the mixture,
water, appropriate amount added to 100 ml.
The preparation process comprises the following steps:
(1) adding xylitol and sorbitol into water accounting for about 80% of the formula amount, slightly heating, stirring to dissolve, and uniformly mixing tomoxetine, a flavoring agent and optional other auxiliary materials to obtain a solution I;
(2) adding an acid-base regulator into the obtained solution II and monitoring the pH value of the solution to enable the pH value to reach the pH value range specified by the prescription;
(3) adding water to full dose, comparing the pH value of the test solution, and adding acid-base regulator if necessary to make the solution reach the pH value range specified by the prescription.
Example 4Tomoxetine oral liquidPreparation of
The prescription composition is as follows:
tomoxetine500mg，
Citric acid 200mg (pH of the final liquid medicine is 4.01),
20g of xylitol, namely 20g of xylitol,
sorbitol 5g
100mg of sodium citrate, namely sodium citrate,
the content of sodium metabisulfite is 100mg,
10mg of the apple essence is added, and the apple essence is added,
water, appropriate amount added to 100 ml.
The preparation process comprises the following steps:
(1) adding xylitol and sorbitol into water accounting for about 80% of the formula amount, slightly heating, stirring to dissolve, and uniformly mixing tomoxetine, a flavoring agent and optional other auxiliary materials to obtain a solution I;
(2) adding an acid-base regulator into the obtained solution II and monitoring the pH value of the solution to enable the pH value to reach the pH value range specified by the prescription;
(3) adding water to full dose, comparing the pH value of the test solution, and adding acid-base regulator if necessary to make the solution reach the pH value range specified by the prescription.
Example 5Tomoxetine oral liquidPreparation of
The prescription composition is as follows:
tomoxetine1000mg，
Citric acid 200mg (pH of the final liquid medicine is 4.05),
20g of xylitol, namely 20g of xylitol,
glycerol 2g
Sorbitol 5g
100mg of sodium citrate, namely sodium citrate,
the content of sodium metabisulfite is 100mg,
10mg of the apple essence is added, and the apple essence is added,
water, appropriate amount added to 100 ml.
The preparation process comprises the following steps:
(1) mixing glycerol and water with the amount of about 80% of the formula, adding xylitol and sorbitol, slightly heating, stirring to dissolve, and uniformly mixing tomoxetine, a flavoring agent and optional other auxiliary materials to obtain a solution I;
(2) adding an acid-base regulator into the obtained solution II and monitoring the pH value of the solution to enable the pH value to reach the pH value range specified by the prescription;
(3) adding water to full dose, comparing the pH value of the test solution, and adding acid-base regulator if necessary to make the solution reach the pH value range specified by the prescription.
Quality evaluation method
And (3) bacteriostatic efficacy test: the results of the bacteriostatic efficacy tests of examples 1-5 according to the guidelines of the bacteriostatic efficacy test in the Chinese pharmacopoeia 2015 edition are shown in Table 1
Table 1.
According to the record of Chinese pharmacopoeia, the L og logarithmic decrease value of the bacteria number of 14 days of bacteria days is not less than 1.0, the bacteria number of 14-28 days is not increased, and the bacteria number of 14 and 28 days is not increased compared with the initial value, namely the standard of the bacteriostatic efficacy is achieved.
Claims (8)
1. Tomoxetine oral liquid, comprising: tomoxetine and its salts, an acid base modifier, a flavoring agent, an antioxidant, a thickening agent, and water, and the pH of the oral liquid is 2.0 to 6.0.
2. The tomoxetine oral liquid of claim 1, wherein the concentration of tomoxetine is 1 mg/m L-30 mg/m L.
3. The tomoxetine oral liquid of claim 1, wherein the acid base modifying agent is selected from the group consisting of: one or more of citric acid, tartaric acid, malic acid, maleic acid, sorbic acid, sodium citrate, and sodium tartrate; wherein the amount of the pH regulator is such that the pH of the solution is in the range of 2.0 to 6.0, for example, 3.0 to 5.0, for example, 3.5 to 4.5.
4. The tomoxetine oral liquid of claim 1, wherein the flavoring agent is selected from the group consisting of: xylitol, sorbitol, maltol, aspartame, acesulfame potassium, flavors, such as water-soluble flavors (e.g., strawberry flavor, orange flavor, pineapple flavor, apple flavor, peppermint flavor, lemon flavor, chocolate flavor, etc.), and combinations thereof.
5. Tomoxetine oral liquid according to claim 4 wherein the amount of flavoring agent per 100ml of said oral liquid is 1-5000 mg, such as 5-2000 mg, such as 5-1000 mg.
6. The tomoxetine oral liquid of claim 1, wherein the antioxidant is selected from the group consisting of sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, vitamin C, and the amount of the oral antioxidant of the present invention is not more than 100mg per 100m L.
7. The tomoxetine oral solution of claims 1 to 6 characterized by any one or more of the following:
(1) wherein a polyhydric alcohol selected from the group consisting of: glycerin, propylene glycol, and combinations thereof;
(2) the amount of the polyhydric alcohol contained in each 100ml of the tomoxetine oral solution may be 0 to 1000mg, for example, 10 to 100 mg.
8. A process for preparing the tomoxetine oral solution of any one of claims 1-7 comprising the steps of:
(1) adding xylitol into water accounting for about 80% of the prescription amount, slightly heating, stirring to dissolve, and uniformly mixing tomoxetine, a flavoring agent and optional other auxiliary materials to obtain a solution I;
(2) adding an acid-base regulator into the obtained solution II and monitoring the pH value of the solution to enable the pH value to reach the pH value range specified by the prescription;
(3) adding water to full dose, comparing the pH value of the test solution, and adding acid-base regulator if necessary to make the solution reach the pH value range specified by the prescription.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910044558.2A CN111437247A (en) | 2019-01-17 | 2019-01-17 | Preparation method of tomoxetine oral liquid |
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| CN201910044558.2A CN111437247A (en) | 2019-01-17 | 2019-01-17 | Preparation method of tomoxetine oral liquid |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111956607A (en) * | 2020-09-25 | 2020-11-20 | 健民药业集团股份有限公司 | Tomoxetine hydrochloride oral solution and preparation method thereof |
| CN115721634A (en) * | 2022-12-02 | 2023-03-03 | 海南卓科制药有限公司 | Tomoxetine hydrochloride composition, preparation method thereof and application thereof in oral solution |
| CN115778895A (en) * | 2022-11-30 | 2023-03-14 | 江苏广承药业有限公司 | Tomoxetine hydrochloride oral solution |
| CN115778895B (en) * | 2022-11-30 | 2024-04-26 | 江苏广承药业有限公司 | Atomoxetine hydrochloride oral solution |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20150133562A1 (en) * | 2013-11-08 | 2015-05-14 | Eli Lilly And Company | Atomoxetine Solution |
| CN105726473A (en) * | 2016-03-31 | 2016-07-06 | 北京万全德众医药生物技术有限公司 | Oral solution of tomoxetine or medicinal salt thereof and preparation method thereof |
| CN106727291A (en) * | 2016-12-06 | 2017-05-31 | 山东达因海洋生物制药股份有限公司 | A kind of tomoxetine hydrochloride oral administration solution and preparation method thereof |
| US9855228B1 (en) * | 2016-12-14 | 2018-01-02 | Taho Pharmaceuticals Ltd. | Oral solution comprising atomoxetine hydrochloride and methods thereof |
| CN108785248A (en) * | 2018-09-20 | 2018-11-13 | 烟台巨先药业有限公司 | A kind of tomoxetine hydrochloride oral solution and preparation method thereof |
-
2019
- 2019-01-17 CN CN201910044558.2A patent/CN111437247A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20150133562A1 (en) * | 2013-11-08 | 2015-05-14 | Eli Lilly And Company | Atomoxetine Solution |
| CN105726473A (en) * | 2016-03-31 | 2016-07-06 | 北京万全德众医药生物技术有限公司 | Oral solution of tomoxetine or medicinal salt thereof and preparation method thereof |
| CN106727291A (en) * | 2016-12-06 | 2017-05-31 | 山东达因海洋生物制药股份有限公司 | A kind of tomoxetine hydrochloride oral administration solution and preparation method thereof |
| US9855228B1 (en) * | 2016-12-14 | 2018-01-02 | Taho Pharmaceuticals Ltd. | Oral solution comprising atomoxetine hydrochloride and methods thereof |
| CN108785248A (en) * | 2018-09-20 | 2018-11-13 | 烟台巨先药业有限公司 | A kind of tomoxetine hydrochloride oral solution and preparation method thereof |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111956607A (en) * | 2020-09-25 | 2020-11-20 | 健民药业集团股份有限公司 | Tomoxetine hydrochloride oral solution and preparation method thereof |
| CN115778895A (en) * | 2022-11-30 | 2023-03-14 | 江苏广承药业有限公司 | Tomoxetine hydrochloride oral solution |
| CN115778895B (en) * | 2022-11-30 | 2024-04-26 | 江苏广承药业有限公司 | Atomoxetine hydrochloride oral solution |
| CN115721634A (en) * | 2022-12-02 | 2023-03-03 | 海南卓科制药有限公司 | Tomoxetine hydrochloride composition, preparation method thereof and application thereof in oral solution |
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Application publication date: 20200724 |