EP3731813A2 - Pharmaceutical compositions for parenteral administration comprising lacosamide - Google Patents

Pharmaceutical compositions for parenteral administration comprising lacosamide

Info

Publication number
EP3731813A2
EP3731813A2 EP18918418.7A EP18918418A EP3731813A2 EP 3731813 A2 EP3731813 A2 EP 3731813A2 EP 18918418 A EP18918418 A EP 18918418A EP 3731813 A2 EP3731813 A2 EP 3731813A2
Authority
EP
European Patent Office
Prior art keywords
acid
pharmaceutical composition
composition according
lacosamide
solution
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP18918418.7A
Other languages
German (de)
French (fr)
Inventor
Ali TÜRKYILMAZ
Arzu Palantöken
Yildiz GÜLKOK
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanovel Ilac Sanayi ve Ticaret AS
Original Assignee
Sanovel Ilac Sanayi ve Ticaret AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanovel Ilac Sanayi ve Ticaret AS filed Critical Sanovel Ilac Sanayi ve Ticaret AS
Publication of EP3731813A2 publication Critical patent/EP3731813A2/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/08—Solutions
    • 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

Definitions

  • the present invention relates to intravenous compositions comprising lacosamide or a pharmaceutically acceptable salt thereof which have reduced impurities and enhanced stability.
  • Lacosamide is an anticonvulsant compound approved for the adjunctive treatment, as well as, conversion to monotherapy and monotherapy treatment of partial-onset seizures and neuropathic pain. It selectively enhances slow inactivation of voltage-gated sodium channels without affecting fast inactivation, thereby stabilizing hyperexcitable neuronal membranes.
  • Inactivation only occurs in neurons firing action potentials; this means that drugs that modulate fast inactivation selectively reduce the firing in active cells. Slow inactivation is similar but does not produce complete blockade of voltage gated sodium channels, with both activation and inactivation occurring over hundreds of milliseconds or more. Lacosamide makes this inactivation happen at less depolarized membrane potentials. This means that lacosamide only affects neurons which are depolarized or active for long periods of time, typical of neurons at the focus of epilepsy.
  • Formula 1 There is lacosamide immediate release formulation licensed in the US and Europe in the form of immediate release tablets, oral solutions and intravenous injection solutions under the brand name Vimpat ® by UCB. Immediate release tablets are currently commercially available in strengths of 50, 100, 150 and 200 mg of lacosamide.
  • the oral dosage forms are not suitable because of their relatively slow onset of action. Instead, intravenous solutions enabling instant onset following the injection can be applied during the seizure itself.
  • the main object of the present invention is to obtain pharmaceutical compositions comprising lacosamide eliminating all aforesaid problems and bringing additional advantages to the relevant prior art.
  • Another object of the present invention is to provide pharmaceutical compositions of lacosamide with high purity.
  • Another object of the present invention is to provide pharmaceutical compositions of lacosamide with high stability and long shelf-life.
  • a further object of the present invention is to provide pharmaceutical compositions of lacosamide for parenteral administration which are in the form of solution.
  • Another object of the present invention is to provide pharmaceutical compositions of lacosamide which are suitable for intravenous administration.
  • the present invention relates to a pharmaceutical composition for parenteral administration comprising lacosamide or a pharmaceutically acceptable salt thereof as active agent, wherein the pH value of the composition is between 3.5 and 5.0.
  • the pH value of the composition is between 3.7 and 4.5.
  • the pH value of the composition is between 3.9 and 4.2.
  • the composition subjected to the invention is in the form of a solution for intravenous injection.
  • the amount of lacosamide is between 0.5 - 90.0% by weight of the total solution. In the most preferred embodiment, the amount of lacosamide is 10 mg per 1 ml. of the total composition.
  • An intravenous solution should be clear, colorless, sterile. Therefore, it is important to choose suitable excipients and to adjust the optimum pH range to achieve enhanced stability and purity for the intravenous formulations of lacosamide.
  • the composition comprises at least one tonicity agent which is selected from the group comprising sodium chloride, propylene glycol, dextrose, glycerin, glycine, glycerol, sucrose, mannitol, sorbitol, potassium chloride, or mixtures thereof.
  • the use of a tonicity agent in the composition is essential, especially for the parenteral dosage forms in a way to make the composition isotonic with body fluids.
  • the amount of the tonicity agent is between 0.1 -20%, preferably 0.1 -5% by weight of the total composition.
  • the composition comprises one tonicity agent which is sodium chloride.
  • the composition further comprises at least one buffer solution to reach the pH values providing improved stability of the pharmaceutical composition subjected to the invention.
  • this buffer solution is selected from a group which does not give a chemical reaction with lacosamide and which does not cause impurities in intravenous solution, accordingly.
  • the buffer solution comprises at least one acidic agent.
  • Acidic agent is preferably selected from the group comprising hydrochloric acid, acetic acid, tartaric acid, ascorbic acid, malic acid, citric acid, formic acid, adipic acid, acetylsalicylic acid, nicotinic acid, benzoic acid, phosphoric acid, acid salts (amino acid hydrochlorides, sodium dihydrogen citrate, disodium hydrogen citrate, sodium acid phosphate) or mixtures thereof.
  • the buffer solution comprises one acidic agent which is hydrochloric acid.
  • the amount of hydrochloric acid is arranged to adjust the pH value of the total composition to the range of 3.5 - 5, preferably 3.7 - 4.5, more preferably 3.9 - 4.2.
  • the composition comprises;
  • the below given formulations can be used in the lacosamide solution for intravenous injection subjected to the invention. These examples are not limiting the scope of the present invention and should be considered under the light of the foregoing detailed disclosure.
  • the pharmaceutical composition mentioned above is prepared by following these steps:

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The present invention relates to intravenous compositions comprising lacosamide or a pharmaceutically acceptable salt thereof which have reduced impurities and enhanced stability.

Description

PHARMACEUTICAL COMPOSITIONS FOR PARENTERAL ADMINISTRATION
COMPRISING LACOSAMIDE
Field of the Invention
The present invention relates to intravenous compositions comprising lacosamide or a pharmaceutically acceptable salt thereof which have reduced impurities and enhanced stability.
Background of the Invention
Lacosamide is an anticonvulsant compound approved for the adjunctive treatment, as well as, conversion to monotherapy and monotherapy treatment of partial-onset seizures and neuropathic pain. It selectively enhances slow inactivation of voltage-gated sodium channels without affecting fast inactivation, thereby stabilizing hyperexcitable neuronal membranes.
Inactivation only occurs in neurons firing action potentials; this means that drugs that modulate fast inactivation selectively reduce the firing in active cells. Slow inactivation is similar but does not produce complete blockade of voltage gated sodium channels, with both activation and inactivation occurring over hundreds of milliseconds or more. Lacosamide makes this inactivation happen at less depolarized membrane potentials. This means that lacosamide only affects neurons which are depolarized or active for long periods of time, typical of neurons at the focus of epilepsy.
Its chemical name is (2R)-2-(acetylamino)-N-benzyl-3-methoxypropanamide and its chemical structure is shown in the Formula 1.
Formula 1 There is lacosamide immediate release formulation licensed in the US and Europe in the form of immediate release tablets, oral solutions and intravenous injection solutions under the brand name Vimpat® by UCB. Immediate release tablets are currently commercially available in strengths of 50, 100, 150 and 200 mg of lacosamide.
In acute seizures associated with life-threatening seizure-like conditions like status epilepticus which require immediate applications to stop the cramps, the oral dosage forms are not suitable because of their relatively slow onset of action. Instead, intravenous solutions enabling instant onset following the injection can be applied during the seizure itself.
However, there are some challenges while producing an intravenous dosage form of lacosamide such as providing stability since it is sparingly soluble in water. Another issue about the lacosamide solutions is the impurity problem which also has a negative influence on stability due to the primer amine group in its chemical structure which has the potential to react with the impurities of excipients.
Accordingly, the above-mentioned complications give rise to a need for an intravenous dosage form of lacosamide with high purity and stability.
Objects and Brief Description of the Invention
The main object of the present invention is to obtain pharmaceutical compositions comprising lacosamide eliminating all aforesaid problems and bringing additional advantages to the relevant prior art.
Another object of the present invention is to provide pharmaceutical compositions of lacosamide with high purity.
Another object of the present invention is to provide pharmaceutical compositions of lacosamide with high stability and long shelf-life.
A further object of the present invention is to provide pharmaceutical compositions of lacosamide for parenteral administration which are in the form of solution.
Another object of the present invention is to provide pharmaceutical compositions of lacosamide which are suitable for intravenous administration. Detailed Description of the Invention
In accordance with the objects outlined above, detailed features of the present invention are given herein.
The present invention relates to a pharmaceutical composition for parenteral administration comprising lacosamide or a pharmaceutically acceptable salt thereof as active agent, wherein the pH value of the composition is between 3.5 and 5.0.
According to the preferred embodiment, the pH value of the composition is between 3.7 and 4.5.
According to the most preferred embodiment, the pH value of the composition is between 3.9 and 4.2.
According to the preferred embodiment, the composition subjected to the invention is in the form of a solution for intravenous injection.
According to this embodiment, the amount of lacosamide is between 0.5 - 90.0% by weight of the total solution. In the most preferred embodiment, the amount of lacosamide is 10 mg per 1 ml. of the total composition.
An intravenous solution should be clear, colorless, sterile. Therefore, it is important to choose suitable excipients and to adjust the optimum pH range to achieve enhanced stability and purity for the intravenous formulations of lacosamide.
Various stability and purity analyses have been conducted on lacosamide solutions with different pH values. The results obtained for different temperatures and different periods of time are given below in Table 1 and Table 2.
Table 1. Impurity results on the 5th month of the lacosamide solutions at 25°C
Table 2. Impurity results on the 3rd month of the lacosamide solutions at 30°C and 40°C
The stability analyses conducted on lacosamide solutions for intravenous injection show that pH values greater than 5.5 negatively affect the solubility of lacosamide and give rise to purity and stability problems. On the other hand, it has been seen a significant increase by time in impurity of the lacosamide solutions which have pH values lower than 3.7.
Following these analyses, it has been surprisingly found that lacosamide solutions in the pH range of 3.7-4.5, more specifically 3.9-4.2 have significantly enhanced purity and accordingly improved stability and extended shelf-life.
According to one embodiment of the invention, the composition comprises at least one tonicity agent which is selected from the group comprising sodium chloride, propylene glycol, dextrose, glycerin, glycine, glycerol, sucrose, mannitol, sorbitol, potassium chloride, or mixtures thereof.
The use of a tonicity agent in the composition is essential, especially for the parenteral dosage forms in a way to make the composition isotonic with body fluids. The amount of the tonicity agent is between 0.1 -20%, preferably 0.1 -5% by weight of the total composition.
According to the preferred embodiment of the invention, the composition comprises one tonicity agent which is sodium chloride.
According to this preferred embodiment, the composition further comprises at least one buffer solution to reach the pH values providing improved stability of the pharmaceutical composition subjected to the invention. Moreover, this buffer solution is selected from a group which does not give a chemical reaction with lacosamide and which does not cause impurities in intravenous solution, accordingly.
According to the preferred embodiment, the buffer solution comprises at least one acidic agent. Acidic agent is preferably selected from the group comprising hydrochloric acid, acetic acid, tartaric acid, ascorbic acid, malic acid, citric acid, formic acid, adipic acid, acetylsalicylic acid, nicotinic acid, benzoic acid, phosphoric acid, acid salts (amino acid hydrochlorides, sodium dihydrogen citrate, disodium hydrogen citrate, sodium acid phosphate) or mixtures thereof.
According to the preferred embodiment of the invention, the buffer solution comprises one acidic agent which is hydrochloric acid. The amount of hydrochloric acid is arranged to adjust the pH value of the total composition to the range of 3.5 - 5, preferably 3.7 - 4.5, more preferably 3.9 - 4.2.
According one preferred embodiment, the composition comprises;
— 0.5-90% by weight of lacosamide,
— 0.1 -20% by weight of sodium chloride,
— quantity sufficient of hydrochloric acid,
— quantity sufficient of water
According to all these embodiments, the below given formulations can be used in the lacosamide solution for intravenous injection subjected to the invention. These examples are not limiting the scope of the present invention and should be considered under the light of the foregoing detailed disclosure.
Example 1 :
q.s.:quantum sufficient
Example 2:
The pharmaceutical composition mentioned above is prepared by following these steps:
- nitrification of water for injection at 20-25°C until the dissolved oxygen level drops below 2.5ppm
- addition of sodium chloride and lacosamide into the nitrified water
- heating and mixing for at least 30 minutes at 30°C to dissolve the mixture until a homogeneous solution is obtained
- checking and adjusting the pH of the mixture with diluted hydrochloric acid solution
- completing the total volume of the mixture to the desired value with water for injection - mixing the total mixture under nitrogen atmosphere for at least 30 minutes
- sterile filtration of the final mixture and filling into vials

Claims

1. A pharmaceutical composition for parenteral administration comprising lacosamide or a pharmaceutically acceptable salt thereof as active agent, wherein the pH value of the composition is between 3.5 and 5.0.
2. The pharmaceutical composition according to claim 1 , wherein the pH value of the composition is between 3.7 and 4.5.
3. The pharmaceutical composition according to claim 2, wherein the pH value of the composition is between 3.9 and 4.2.
4. The pharmaceutical composition according to any preceding claim, wherein the composition is in the form of a solution for intravenous injection.
5. The pharmaceutical composition according to any preceding claim, wherein the amount of lacosamide is between 0.5 - 90.0% by weight of the total solution.
6. The pharmaceutical composition according to any preceding claim, wherein the composition comprises at least one tonicity agent which is selected from the group comprising sodium chloride, propylene glycol, dextrose, glycerin, glycine, glycerol, sucrose, mannitol, sorbitol, potassium chloride, or mixtures thereof.
7. The pharmaceutical composition according to claim 6, wherein the amount of the tonicity agent is between 0.1 -20%, preferably 0.1 -5% by weight of the total composition.
8. The pharmaceutical composition according to claim 6 or 7, wherein the composition comprises one tonicity agent which is sodium chloride.
9. The pharmaceutical composition according to any preceding claim, the composition further comprises at least one buffer solution.
10. The pharmaceutical composition according to claim 9, the buffer solution comprises at least one acidic agent selected from hydrochloric acid, acetic acid, tartaric acid, ascorbic acid, malic acid, citric acid, formic acid, adipic acid, acetylsalicylic acid, nicotinic acid, benzoic acid, phosphoric acid, acid or mixtures thereof.
1 1. The pharmaceutical composition according to claim 10, wherein the buffer solution comprises one acidic agent which is hydrochloric acid.
12. The pharmaceutical composition according to any preceding claim, wherein the composition comprises;
0.5-90% by weight of lacosamide,
0.1 -20% by weight of sodium chloride,
quantity sufficient of hydrochloric acid,
quantity sufficient of water
13. A process for preparing the pharmaceutical composition according to claim 12, comprising the following steps:
-nitrification of water for injection at 20-25°C until the dissolved oxygen level
drops below 2.5ppm
-addition of sodium chloride and lacosamide into the nitrified water
-heating and mixing for at least 30 minutes at 30°C to dissolve the mixture until a homogeneous solution is obtained
-checking and adjusting the pH of the mixture with diluted hydrochloric acid solution -completing the total volume of the mixture to the desired value with water for injection
-mixing the total mixture under nitrogen atmosphere for at least 30 minutes
-sterile filtration of the final mixture and filling into vials
EP18918418.7A 2017-12-27 2018-12-26 Pharmaceutical compositions for parenteral administration comprising lacosamide Pending EP3731813A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2017/22367A TR201722367A2 (en) 2017-12-27 2017-12-27 PHARMACEUTICAL COMPOSITIONS FOR PARENTERAL APPLICATION CONTAINING LACOSAMIDE
PCT/TR2018/050904 WO2019240697A2 (en) 2017-12-27 2018-12-26 Pharmaceutical compositions for parenteral administration comprising lacosamide

Publications (1)

Publication Number Publication Date
EP3731813A2 true EP3731813A2 (en) 2020-11-04

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ID=67900901

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Application Number Title Priority Date Filing Date
EP18918418.7A Pending EP3731813A2 (en) 2017-12-27 2018-12-26 Pharmaceutical compositions for parenteral administration comprising lacosamide

Country Status (3)

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EP (1) EP3731813A2 (en)
TR (1) TR201722367A2 (en)
WO (1) WO2019240697A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116392440A (en) * 2023-03-30 2023-07-07 岳阳新华达制药有限公司 A kind of preparation method of lacosamide oral solution

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112022804A (en) * 2020-09-28 2020-12-04 健民药业集团股份有限公司 Lacosamide oral solution and preparation method thereof
US11278634B1 (en) 2021-02-12 2022-03-22 Extrovis Ag Stable parenteral composition of lacosamide

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104771356A (en) * 2014-01-09 2015-07-15 山东方明药业集团股份有限公司 Lacosamide injection and preparation method thereof

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8853453B2 (en) * 2010-01-29 2014-10-07 Ranbaxy Laboratories Limited Processes for reducing impurities in lacosamide
EP3074004A2 (en) * 2013-11-29 2016-10-05 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

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104771356A (en) * 2014-01-09 2015-07-15 山东方明药业集团股份有限公司 Lacosamide injection and preparation method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116392440A (en) * 2023-03-30 2023-07-07 岳阳新华达制药有限公司 A kind of preparation method of lacosamide oral solution

Also Published As

Publication number Publication date
TR201722367A2 (en) 2019-07-22
WO2019240697A3 (en) 2020-02-13
WO2019240697A2 (en) 2019-12-19

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