CN112022804A - Lacosamide oral solution and preparation method thereof - Google Patents
Lacosamide oral solution and preparation method thereof Download PDFInfo
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- CN112022804A CN112022804A CN202011044027.2A CN202011044027A CN112022804A CN 112022804 A CN112022804 A CN 112022804A CN 202011044027 A CN202011044027 A CN 202011044027A CN 112022804 A CN112022804 A CN 112022804A
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- lacosamide
- oral solution
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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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
-
- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61P25/08—Antiepileptics; Anticonvulsants
Abstract
The invention relates to a lacosamide oral solution, which comprises lacosamide, a solubilizer, a thickening agent, a flavoring agent, an acidity regulator and a preservative; wherein the mass concentration of the lacosamide is 10mg/mL, the mass concentration of the solubilizer is 100-150mg/mL, the mass concentration of the thickener is 0.5-1.5mg/mL, the mass concentration of the flavoring agent is 180-300mg/mL, the mass concentration of the acidity regulator is 1.9-4mg/mL, the mass concentration of the preservative is 2-3mg/mL, and the balance is water. The pH value of the oral solution is controlled to be 3.5-6.0 by adding the acidity regulator, the solubility of the lacosamide is improved by adding the solubilizer, and the stability of the oral solution is improved by the thickener, so that the lacosamide can be uniformly dispersed in the oral solution. The preparation method is simple and efficient.
Description
Technical Field
The invention relates to the technical field of medicinal preparations, in particular to lacosamide oral solution and a preparation method thereof.
Background
Epilepsy is a chronic disease in which there is a sudden abnormal firing of cerebral neurons, resulting in transient cerebral dysfunction. According to the latest Chinese epidemiological data, the total prevalence rate of domestic epilepsy is 7.0 per thousand, the annual incidence rate is 28.8/10 ten thousand, and the prevalence rate of active epilepsy with attacks within 1 year is 4.6 per thousand. Therefore, about 900 million epilepsy patients are estimated in China, 500-600 million of the epilepsy patients are active epilepsy patients, about 40 million epilepsy patients are newly added every year, and epilepsy has become the second most common disease of the neurology department, second to headache in China.
The Lacosamide (Lacosamide) as a third-generation novel antiepileptic drug has obvious treatment advantages and wide application prospect.
At present, the lacosamide is mainly applied to tablets, capsules and the like in clinic, and is difficult to take by dysphagia patients. For children patients, the dosage of administration is not easy to be accurately controlled, and the treatment effect is influenced. The masking of the bitter taste of the medicine by the pharmaceutical science means is an important strategy for improving the medicine taking compliance of children and the clinical reasonable medicine taking, and the problem that the taste of the tablet is poor and the administration dosage is difficult to accurately control can be effectively solved by preparing the lacosamide into the oral solution. However, the concentration of lacosamide and some auxiliary materials for preparing the oral solution is not uniform after the lacosamide and the auxiliary materials are difficult to dissolve in water and stand, the preparation process has certain complexity, and the preparation has more known impurities, so that the oral solution meeting the relevant standards is difficult to prepare.
Disclosure of Invention
Based on this, there is a need for lacosamide oral solution and a preparation method thereof. The lacosamide oral solution has good taste and compliance, is convenient for accurately controlling the administration dosage, has stable property, and the impurity content meets the related standard.
The technical scheme for solving the technical problems is as follows: a lacosamide oral solution comprising lacosamide, a solubilizer, a thickener, a flavoring agent, an acidity regulator, and a preservative; wherein the mass concentration of the lacosamide is 10mg/mL, the mass concentration of the solubilizer is 100-150mg/mL, the mass concentration of the thickener is 0.5-1.5mg/mL, the mass concentration of the flavoring agent is 180-300mg/mL, the mass concentration of the acidity regulator is 1.9-4mg/mL, the mass concentration of the preservative is 2-3mg/mL, and the balance is water; the acidity regulator regulates the pH value of the lacosamide oral solution to 3.5-6.0.
Preferably, the solubilizer is one or more of polyethylene glycol, glycerol and propylene glycol.
Preferably, the thickener is sodium carboxymethyl cellulose.
Preferably, the flavoring agents include sweeteners, flavoring agents and flavors; the sweetener is one or more of sorbitol, xylitol, isomaltulose, maltitol, mannan, sucrose, saccharin sodium and aspartame; the flavoring agent is one or more of ethyl maltol and maltol; the flavoring agent is one or more of apple essence, orange essence, cherry powder and banana essence.
Preferably, the acidity regulator is one or more of citric acid, malic acid, tartaric acid and sodium gluconate.
Preferably, the preservative is one or more of parabens, benzoic acid and salts thereof, sorbic acid and salts thereof.
Preferably, the lacosamide has a mass concentration of 10mg/mL, the solubilizers are respectively glycerol, propylene glycol and polyethylene glycol 4000, and the mass concentrations are 72.4mg/mL, 2.0mg/mL and 65mg/mL in sequence; the thickening agent is sodium carboxymethylcellulose, and the mass concentration is 0.5 mg/mL; the corrigent is sorbitol, acesulfame potassium, aspartame, strawberry essence and maltol, and the mass concentration is 207mg/mL, 2.6mg/mL, 0.015mg/mL, 0.3mg/mL and 0.02mg/mL in sequence; the acidity regulator is citric acid with the mass concentration of 1.9 mg/mL; the preservative is sodium methyl hydroxybenzoate, and the mass concentration is 2.3 mg/mL.
The invention also provides a preparation method of the lacosamide oral solution, which comprises the following steps:
adding purified water accounting for 45% of the total amount of the prepared solution, and starting stirring;
wetting the flavoring agent by using purified water accounting for 0.3 percent of the total amount of the prepared liquid, putting the wetted flavoring agent into a tank, and stirring the wetted flavoring agent until the wetted flavoring agent is completely dissolved;
slowly adding the thickening agent, and stirring until the dispersion and swelling are complete;
sequentially adding acidity regulator, sweetener, flavoring agent and antiseptic, and stirring to dissolve completely;
adding lacosamide, adding purified water to 95% of the total amount of the preparation solution, and stirring until the lacosamide is completely dissolved;
adding flavoring agent, and weighing to total amount of the solution;
filtering;
filling;
and (6) performing light inspection.
The invention has the beneficial effects that:
(1) the taste of lacosamide is effectively improved by adding the flavoring agent, the compliance of the medicine is improved, and the effects of improving the medicine taking compliance of children and the clinical medicine taking rationality are obvious, so that the treatment effect on epileptics is better.
(2) The pH value of the oral solution is controlled to be 3.5-6.0 by adding the acidity regulator, meanwhile, the solubility of the lacosamide is improved by adding the solubilizer, and the stability of the oral solution is improved by the thickener, so that the lacosamide can be uniformly dispersed in the oral solution and has stable property.
(3) The preparation method has simple and efficient preparation process.
(4) The impurity content of the lacosamide oral liquid prepared by the invention meets the international mainstream standard.
Detailed Description
The starting materials and reagents used in the following examples are, unless otherwise specified, commercially available conventional starting materials and reagents.
Example 1
This example provides a lacosamide oral solution, which is prepared from the raw materials including those in table 1.
Table 1 lacosamide oral solution composition of example 1
The preparation method of the lacosamide oral solution of the embodiment comprises the following steps:
s1, adding 450g of purified water into the stirring tank, and starting stirring;
s2, wetting the flavoring agent maltol by using 3g of purified water, putting the wetted flavoring agent maltol into a tank, and stirring until the solution is completely dissolved;
s3, slowly adding the thickening agent sodium carboxymethyl cellulose, and stirring until the dispersion and swelling are complete;
s4, sequentially adding citric acid, sorbitol, aspartame, acesulfame potassium, polyethylene glycol 4000, glycerol, propylene glycol and sodium methyl hydroxybenzoate, and stirring until the mixture is completely dissolved;
s5, adding lacosamide, adding purified water to 950mL, and stirring until the lacosamide is completely dissolved;
s6, adding strawberry essence, and fixing the volume to 1L;
s7, filtering;
s8, filling;
and S9, light inspection.
Example 2
This example provides a lacosamide oral solution, which is prepared from the raw materials including those in table 2.
Table 2 lacosamide oral solution components of example 2
The preparation method of the lacosamide oral solution of the embodiment comprises the following steps:
s1, adding 450g of purified water into the stirring tank, and starting stirring;
s2, wetting ethyl maltol by using 3g of purified water, putting the wetted ethyl maltol into a tank, and stirring until the ethyl maltol is completely dissolved;
s3, slowly adding the thickening agent sodium carboxymethyl cellulose, and stirring until the dispersion and swelling are complete;
s4, sequentially adding citric acid, maltitol, xylitol, saccharin sodium, polyethylene glycol 4000 and sodium methyl hydroxybenzoate, and stirring until the mixture is completely dissolved;
s5, adding lacosamide, adding purified water to 950mL, and stirring until the lacosamide is completely dissolved;
s6, adding banana essence, and fixing the volume to 1L;
s7, filtering;
s8, filling;
and S9, light inspection.
Example 3
This example provides a lacosamide oral solution, which is prepared from the raw materials comprising item 3.
Table 3 lacosamide oral solution components of example 3
The preparation method of the lacosamide oral solution of the embodiment comprises the following steps:
s1, adding 450g of purified water into the stirring tank, and starting stirring;
s2, wetting maltol with 3g of purified water, putting the maltol into a tank, and stirring until the maltol is completely dissolved;
s3, slowly adding sodium carboxymethyl cellulose, and stirring until the dispersion and swelling are complete;
s4, sequentially adding malic acid, maltitol, sorbitol, sucrose, polyethylene glycol 4000, glycerol, propylene glycol and benzoic acid, and stirring until completely dissolving;
s5, adding lacosamide, adding purified water to 950mL, and stirring until the lacosamide is completely dissolved;
s6, adding apple essence, and fixing the volume to 1L;
s7, filtering;
s8, filling;
and S9, light inspection.
In examples 1 to 3, the solubilizer was added so that lacosamide was completely dissolved, and the stirring time in step S5 was 30 to 40 min.
Comparative example 1
The comparative example provides a lacosamide oral solution prepared from the raw materials comprising 4.
Table 4 lacosamide oral solution composition of comparative example 1
The preparation method of the lacosamide oral solution of the embodiment comprises the following steps:
s1, adding 450g of purified water into the stirring tank, and starting stirring;
s2, wetting maltol with 3g of purified water, putting the maltol into a tank, and stirring until the maltol is completely dissolved;
s3, slowly adding the thickening agent sodium carboxymethyl cellulose, and stirring until the dispersion and swelling are complete;
s4, sequentially adding malic acid, maltitol, sorbitol, sucrose and benzoic acid, and stirring until completely dissolved;
s5, adding lacosamide, adding purified water to 950mL, and stirring until the lacosamide is completely dissolved;
s6, adding apple essence, and fixing the volume to 1L;
s7, filtering;
s8, filling;
and S9, light inspection.
In the comparative example, the stirring time of step S5 is 2 to 3 hours for complete dissolution of lacosamide.
Comparative example 2
The comparative example provides a lacosamide oral solution prepared from the raw materials comprising 5.
Table 5 lacosamide oral solution composition of comparative example 2
The preparation method of the lacosamide oral solution of the embodiment comprises the following steps:
s1, adding 450g of purified water into the stirring tank, and starting stirring;
s2, wetting maltol with 3g of purified water, putting the maltol into a tank, and stirring until the maltol is completely dissolved;
s3, sequentially adding malic acid, maltitol, sorbitol, sucrose, polyethylene glycol 4000, glycerol, propylene glycol and benzoic acid, and stirring until completely dissolved;
s4, adding lacosamide, adding purified water to 950mL, and stirring until the lacosamide is completely dissolved;
s5, adding apple essence, and fixing the volume to 1L;
s6, filtering;
s7, filling;
and S8, light inspection.
Experimental example 1
And (5) detecting the stability.
The stability of the lacosamide oral solution and the content of impurities after accelerated treatment are detected, and the detection results are shown in table 5.
TABLE 5 stability of lacosamide oral solution
Experimental example 2
And (5) measuring impurities.
The maximum unknown single impurity and total impurity of the related substances in the lacosamide oral solution prepared on the same day are determined. The results are shown in Table 6.
TABLE 6 Lacoxsacine oral solution impurity determination results
| Investigation item | Example 1 | Example 2 | Example 3 | Comparative example 1 | Comparative example 2 |
| Maximum unknown simple impurity | 0.03％ | 0.03％ | 0.04％ | 0.44％ | 0.04％ |
| Total miscellaneous | 0.03％ | 0.06％ | 0.07％ | 1.31％ | 0.05％ |
| Content (wt.) | 99.3％ | 99.4％ | 100.5 | 96.6％ | 99.6％ |
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (8)
1. A lacosamide oral solution, wherein the lacosamide oral solution comprises lacosamide, a solubilizer, a thickener, a flavoring agent, an acidity regulator and a preservative; wherein the mass concentration of the lacosamide is 10mg/mL, the mass concentration of the solubilizer is 100-150mg/mL, the mass concentration of the thickener is 0.5-1.5mg/mL, the mass concentration of the flavoring agent is 180-300mg/mL, the mass concentration of the acidity regulator is 1.9-4mg/mL, the mass concentration of the preservative is 2-3mg/mL, and the balance is water; the acidity regulator regulates the pH value of the lacosamide oral solution to 3.5-6.0.
2. Lacosamide oral solution according to claim 1, wherein the solubilizer is one or more of polyethylene glycol, glycerol and propylene glycol.
3. Lacosamide oral solution according to claim 1, wherein the thickening agent is sodium carboxymethylcellulose.
4. Lacosamide oral solution according to claim 1, wherein the flavoring agent comprises a sweetener, a flavoring agent and a fragrance; the sweetener is one or more of sorbitol, xylitol, isomaltulose, maltitol, mannan, sucrose, saccharin sodium and aspartame; the flavoring agent is one or more of ethyl maltol and maltol; the flavoring agent is one or more of apple essence, orange essence, cherry powder and banana essence.
5. The lacosamide oral solution of claim 1, wherein the acidity regulator is one or more of citric acid, malic acid, tartaric acid, and sodium gluconate.
6. Lacosamide oral solution according to claim 1, wherein the preservative is one or more of parabens, benzoic acid and salts thereof, sorbic acid and salts thereof.
7. The lacosamide oral solution of claim 1, wherein the lacosamide has a mass concentration of 10mg/mL, the solubilizers are glycerol, propylene glycol and polyethylene glycol 4000, and the mass concentrations are 72.4mg/mL, 2.0mg/mL and 65mg/mL in this order; the thickening agent is sodium carboxymethylcellulose, and the mass concentration is 0.5 mg/mL; the corrigent is sorbitol, acesulfame potassium, aspartame, strawberry essence and maltol, and the mass concentration is 207mg/mL, 2.6mg/mL, 0.015mg/mL, 0.3mg/mL and 0.02mg/mL in sequence; the acidity regulator is citric acid with the mass concentration of 1.9 mg/mL; the preservative is sodium methyl hydroxybenzoate, and the mass concentration is 2.3 mg/mL.
8. A process for the preparation of lacosamide oral solution as claimed in any of claims 1 to 7, comprising the steps of:
adding purified water accounting for 45% of the total amount of the prepared solution, and starting stirring;
wetting the flavoring agent by using purified water accounting for 0.3 percent of the total amount of the prepared liquid, putting the wetted flavoring agent into a tank, and stirring the wetted flavoring agent until the wetted flavoring agent is completely dissolved;
slowly adding the thickening agent, and stirring until the dispersion and swelling are complete;
sequentially adding acidity regulator, sweetener, flavoring agent and antiseptic, and stirring to dissolve completely;
adding lacosamide, adding purified water to 95% of the total amount of the preparation solution, and stirring until the lacosamide is completely dissolved;
adding flavoring agent, and weighing to total amount of the solution;
filtering;
filling;
and (6) performing light inspection.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202011044027.2A CN112022804A (en) | 2020-09-28 | 2020-09-28 | Lacosamide oral solution and preparation method thereof |
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| CN202011044027.2A CN112022804A (en) | 2020-09-28 | 2020-09-28 | Lacosamide oral solution and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115645357A (en) * | 2022-08-03 | 2023-01-31 | 上海奥科达生物医药科技有限公司 | Lacosamide oral solution prescription and preparation process thereof |
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| CN103561727A (en) * | 2010-12-02 | 2014-02-05 | 优时比制药有限公司 | Once daily formulation of lacosamide |
| US20170035733A1 (en) * | 2013-11-29 | 2017-02-09 | Ucb Pharma Gmbh | Pharmaceutical composition comprising lacosamide and levetiracetam |
| CN106551900A (en) * | 2016-12-05 | 2017-04-05 | 北京万全德众医药生物技术有限公司 | A kind of scheme for lacosamide oral administration solution and its preparation technology |
| WO2019240697A2 (en) * | 2017-12-27 | 2019-12-19 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Pharmaceutical compositions for parenteral administration comprising lacosamide |
| CN111096948A (en) * | 2018-10-25 | 2020-05-05 | 北京万全德众医药生物技术有限公司 | Lacosamide oral liquid and preparation method thereof |
-
2020
- 2020-09-28 CN CN202011044027.2A patent/CN112022804A/en active Pending
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| CN103561727A (en) * | 2010-12-02 | 2014-02-05 | 优时比制药有限公司 | Once daily formulation of lacosamide |
| US20170035733A1 (en) * | 2013-11-29 | 2017-02-09 | Ucb Pharma Gmbh | Pharmaceutical composition comprising lacosamide and levetiracetam |
| CN106551900A (en) * | 2016-12-05 | 2017-04-05 | 北京万全德众医药生物技术有限公司 | A kind of scheme for lacosamide oral administration solution and its preparation technology |
| WO2019240697A2 (en) * | 2017-12-27 | 2019-12-19 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Pharmaceutical compositions for parenteral administration comprising lacosamide |
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Non-Patent Citations (1)
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115645357A (en) * | 2022-08-03 | 2023-01-31 | 上海奥科达生物医药科技有限公司 | Lacosamide oral solution prescription and preparation process thereof |
| CN115645357B (en) * | 2022-08-03 | 2024-03-12 | 上海奥科达医药科技股份有限公司 | Prescription of lacosamide oral solution and preparation process thereof |
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Application publication date: 20201204 |