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Solutions for oral dosage

Pending Publication Date: 2022-11-03
FTF PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent is about a pharmaceutical composition that contains a stable solution of a medication that is soluble in water but can still be hydrolyzed. The composition uses a minimum amount of solvent and can be used to treat various diseases or disorders such as depression and anxiety. The composition includes a water-soluble medication, a vehicle, a surfactant, and a solubilizer. The composition can also contain other additives such as antioxidants, sweeteners, flavoring agents, and chelating agents. The technical effect of this patent is to provide a stable and effective pharmaceutical composition that can be used to treat various diseases or disorders while minimizing the risk of hydrolysis.

Problems solved by technology

It is known that “pill splitting” can adversely affect dosage accuracy and the stability of medications.
Hence, it is desirable to have a liquid formulation of amitriptyline, but such formulations are not available commercially due to many issues with formulating the drug in a liquid form, including problems with stability.

Method used

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  • Solutions for oral dosage

Examples

Experimental program
Comparison scheme
Effect test

example 1

Oral Pharmaceutical Composition Comprising Amitriptyline Hydrochloride

[0074]

Role ofQuantitySr. No.Ingredientsingredients% w / v(mg / mL)1AmitriptylineActive440Hydrochloride(equivalent toamitriptyline)2GlycerolStabilizer / solubilizer383803SucraloseSweetener0.554Suitable FlavorFlavor0.020.25Polysorbate 80Surfactant0.116Purified WaterVehicleq.s to 100 mlQ.S. 1 mL

[0075]Preparation of the formulation above was as follows:[0076]a. Add sufficient quantity of purified water in vessel[0077]b. Add glycerin and mix until homogenously dispersed[0078]c. Add polysorbate 80 and mix until dispersed[0079]d. Add amitriptyline and mix until dissolved[0080]e. Add sucralose and flavor one by one and mix until dissolved[0081]f. Volume make up until it reaches batch size, filter and fill in to suitable packaging

[0082]Those who are skilled in the art can also understand that some variations in the herein described processes for the preparation of liquid compositions of the present invention can be adopted which...

example 2

Study Results of Amitriptyline Liquid Composition

[0084]The oral liquid pharmaceutical composition prepared according to Example 1 exhibits unexpected stability profile when tested after six months:

TestStorage condition40° C. ± 2° C. / NMT75% RH25° C. ± 2° C. / 60 ± 5% RHparametersTentative specificationInitial3 M6 M3 M6 MDescriptionA clear colorless to paleCompliesCompliesCompliesCompliesCompliesyellow colored solutionwith characteristic odor.pHBetween 3.5 and 5.54.5  4.7  4.0  4.8  4.2  Assay ofBetween 90.0% and99.50% 95.80% 100.90% 102.90% 100.60% Amitriptyline110.0% of labeledamount.RelatedSubstanceImpurity -ANot more than 0.2%NDBQLBQLBQLBQLImpurity -BNot more than 0.2%0.08%0.07%0.08%0.08%0.08%(RRT(RRT(RRT(RRT(RRT0.78) 0.78) 0.78) 0.78) 0.78) SingleNot more than 0.2%NDBQLBQLBQLBQLMaximumUnknownimpurityTotalNot more than 1.0%0.08%0.07%0.08%0.08%0.08%Impurities

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Abstract

Pharmaceutical compositions comprising a vehicle, a solubilizer, and a surfactant are disclosed to be used in conjunction with non-chemotherapeutic active pharmaceutical ingredients which are soluble in water but subject to hydrolysis to some extent. Such non-chemotherapeutic active pharmaceutical ingredients may include amitriptyline, a derivative thereof, or a combination thereof. The pharmaceutical compositions may be administered as an oral solution. Other embodiments are directed towards methods of using and methods of making such formulations.

Description

FIELD OF THE INVENTION[0001]The present invention relates a pharmaceutical composition comprising a vehicle, a solubilizer, and a surfactant are disclosed to be used in conjunction with non-chemotherapeutic active pharmaceutical ingredients which are soluble in water but subject to hydrolysis to some extent which is amitriptyline. The pharmaceutical compositions may be administered as an oral solution. Other embodiments are directed towards methods of using and methods of making such formulations.BACKGROUND OF THE INVENTION[0002]Amitriptyline hydrochloride (HCl) is a dibenzocycloheptene-derivative tricyclic antidepressant (TCA) and analgesic. Amitriptyline may be used to treat neuropathic pain or conditions associated therewith.[0003]Amitriptyline HCl, 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, is a white, odorless, crystalline compound which is freely soluble in water. Its empirical formula is C20H23N●HCl and its structural f...

Claims

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Application Information

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IPC IPC(8): A61K31/135A61K9/08A61K9/00A61K47/10A61K47/26
CPCA61K31/135A61K9/08A61K9/0053A61K47/10A61K47/26A61P25/00A61P25/22A61P25/24A61P25/18A61P25/06A61P13/02A61P1/00A61P25/04A61P25/20A61K9/0095
Inventor PATEL, VIJAYMEHTA, SANDIP PARESHBHAIUMRETHIA, MANISHMANDAL, JAYANTA KUMAR
Owner FTF PHARMA
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