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WO2023248241A1 - Composition pharmaceutique orale de cyclizine ou d'un sel pharmaceutiquement acceptable de celle-ci - Google Patents

Composition pharmaceutique orale de cyclizine ou d'un sel pharmaceutiquement acceptable de celle-ci Download PDF

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Publication number
WO2023248241A1
WO2023248241A1 PCT/IN2023/050586 IN2023050586W WO2023248241A1 WO 2023248241 A1 WO2023248241 A1 WO 2023248241A1 IN 2023050586 W IN2023050586 W IN 2023050586W WO 2023248241 A1 WO2023248241 A1 WO 2023248241A1
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Prior art keywords
pharmaceutical composition
suspension
cyclizine
mixing
pharmaceutically acceptable
Prior art date
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Ceased
Application number
PCT/IN2023/050586
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English (en)
Inventor
Girish Shantilal Achliya
Mayur Dilip KAPADIA
Dipak Rameshbhai Faldu
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Syri Research Private Ltd
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Syri Research Private Ltd
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
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Publication of WO2023248241A1 publication Critical patent/WO2023248241A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D295/00—Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms
    • C07D295/02—Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms containing only hydrogen and carbon atoms in addition to the ring hetero elements
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines

Definitions

  • the present invention relates to oral pharmaceutical composition of Cyclizine or its pharmaceutically acceptable salt thereof.
  • the present invention particularly relates to oral liquid pharmaceutical composition of Cyclizine or pharmaceutically acceptable salt thereof.
  • This invention also relates to the process for the preparation of said pharmaceutical composition.
  • Motion sickness occurs due to passive body movement in response to actual motion or illusion of the motion. Motion sickness cannot be considered as true sickness.
  • the cardinal signs of motion sickness are nausea, vomiting and dizziness associated with sighing, yawning, hyperventilation, flatulence, loss of body weight, headache and drowsiness.
  • Pharmacological therapy for the management of motion sickness primarily involves the use of anticholinergics and antihistamines.
  • Anticholinergics when used in the treatment of motion sickness; it shows severe effects like bradycardia, dry mouth, blurred vision, dilation of pupil. Therefore, antihistamines are preferred over anticholinergics.
  • Cyclizine is a piperazine-derived antihistamine that is used to treat vertigo and nausea. It is used to prevent and treat motion sickness symptoms such as nausea, vomiting, and dizziness. In addition; it has been used to treat vertigo caused by disorders of the vestibular apparatus.
  • cyclizine exerts its antiemetic and antivertigo actions
  • its anticholinergic characteristics are thought to play a role.
  • the medication reduces labyrinth excitability and vestibular stimulation, as well as having an effect on the medullary chemoreceptor trigger zone.
  • Anticholinergic, antihistaminic, central nervous system depressant and local anaesthetic properties are also found.
  • W02018002696A1 is related to the improved process of preparation of Cyclizine Hydrochloride.
  • the application GB906422A discloses the prolonged acting tablet comprising one or more pharmaceutically acceptable ingredients.
  • EP0201537B1 discloses the nasal administration of antihistaminics to inhibit nausea and emesis.
  • the antihistaminic agent is selected from cyclizine, chlorcyclizine, meclizine or buclizine.
  • GB 1018125 A also discloses the self propelling medicament comprising Cyclizine with appropriate propellant for nasal administration.
  • IN201841019335 discloses the stable taste masked liquid composition comprising Cyclizine Hydrochloride, taste masking agent(s) and pharmaceutically acceptable excipients
  • the nasal drug delivery system has several disadvantages including, rapid elimination of drug substance from nasal cavity, difficulty in administration in travelling which can lead to mechanical loss of dosage form, nasal congestion due to allergic condition or cold may interfere the accurate dosing of drug.
  • the present invention provides solution to the problems arising in the prior art.
  • the present invention also provides stable, bioequivalent, easy to manufacture as well as easy to administer oral composition of Cyclizine or its pharmaceutically accepted salt thereof.
  • the present invention relates to an oral pharmaceutical composition of Cyclizine or pharmaceutically acceptable salt thereof.
  • the present invention relates to an oral liquid pharmaceutical composition of Cyclizine or pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable ingredients and process of preparation thereof.
  • the present invention relates to an oral liquid pharmaceutical composition of Cyclizine or pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable ingredients, wherein the liquid pharmaceutical composition is stable for at least one month or two month or three month or six month under storage condition of 25°C/60% RH and/or 30°C/65% RH and/or 40°C/75% and/or 2-8°C.
  • the present invention relates to an oral liquid pharmaceutical composition of Cyclizine or pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable ingredients, wherein the liquid pharmaceutical composition is selected from suspension, solution or the like and any combination thereof.
  • the present invention provides an oral liquid pharmaceutical composition
  • an oral liquid pharmaceutical composition comprising; a) cyclizine or pharmaceutically acceptable salt thereof; b) preservative; c) viscosity modifier; d) anti- foaming agent; e) sweetener; and f) one or more pharmaceutically acceptable excipients.
  • the present invention provides an oral liquid pharmaceutical composition
  • an oral liquid pharmaceutical composition comprising; a) Cyclizine or pharmaceutically acceptable salt thereof; b) preservative; c) viscosity modifying agent or solubilizer; d) sweetener; e) antifoaming agent; f) optionally dispersing agent or suspending agent; and g) one or more pharmaceutically acceptable excipient.
  • the present invention provides a process for preparation of stable oral liquid pharmaceutical composition
  • a process for preparation of stable oral liquid pharmaceutical composition comprising; a) soaking viscosity modifier in vehicle; b) separately dissolving preservative and sweetener in vehicle and mixing to get clear colourless solution; c) adding and mixing antifoaming agent into above solution to get white coloured homogenous suspension; d) adding and dispersing Cyclizine HC1 in above suspension and mixing to get white coloured homogeneous suspension; e) adding and mixing step a) dispersion into above suspension to get white coloured suspension; f) adding and mixing flavor into above dispersion to get white coloured homogeneous dispersion; g) adding and mixing pH modifying agent get desired pH and h) making up the volume with vehicle and mixing to get white coloured homogeneous dispersion.
  • the present invention provides a process for preparation of stable oral liquid pharmaceutical composition
  • a process for preparation of stable oral liquid pharmaceutical composition comprising; a) soaking viscosity modifier in vehicle; b) adding and dissolving solubilizer in vehicle to get clear colourless solution; c) adding and dissolving Cyclizine HC1 into above solution to get clear colourless solution; d) adding and dissolving preservative and sweetener into above solution to get clear colourless solution; e) adding and dissolving viscosity modifier into above solution to get clear colourless dispersion; f) adding and mixing antifoaming agent into above dispersion to get white coloured homogeneous suspension; g) adding and dissolving suspending agent into above solution to get off white colour suspension; h) adding and mixing dispersing agent into above suspension to get white coloured homogeneous suspension; i) adding and mixing flavour into above suspension to get white coloured homogeneous suspension; j) adding and mixing pH modifying agent get desired pH; and k) making up
  • the present invention provides a method for using oral liquid pharmaceutical composition comprising Cyclizine or pharmaceutically acceptable salt thereof for the treatment of nausea and vomiting symptoms associated with narcotic analgesics, general anaesthesia in the post-operative period, vertigo, meniere’s disease, vestibular disturbance, motion sickness, radiotherapy-induced emesis in mastectomy patients.
  • terapéuticaally effective amount is defined to mean the amount or quantity of the active drug (e.g. Cyclizine or a pharmaceutically acceptable salt), which is sufficient to elicit an appreciable biological response when administered to the patient.
  • active drug e.g. Cyclizine or a pharmaceutically acceptable salt
  • excipient or “ingredient” means a pharmacologically inactive component such as a vehicle, suspending agent, preservative, sweetener, or the like.
  • the excipient that are useful in preparing a pharmaceutical composition are generally safe, non-toxic and are acceptable for veterinary as well as human pharmaceutical use. Reference to an excipient includes both one and more than one such excipient.
  • formulation or “composition” or “pharmaceutical composition” or “dosage form” or “liquid formulation” or “liquid pharmaceutical composition” as used herein synonymously include dosage forms such as suspension, solution and the like.
  • stable or “stability” encompass any characteristic of the liquid compositions which may be affected by storage conditions including, without limitation, potency, total impurities, degradation products, specific optical rotation, optical purity, water content, appearance, viscosity, sterility, and colour and clarity.
  • the storage conditions which may affect stability include, for example, duration of storage, temperature, humidity, and/or light exposure.
  • “Pharmaceutically acceptable excipient(s)” are components that are added to the pharmaceutical composition other than the active ingredient Cyclizine. Excipient may be added to facilitate manufacture, enhance stability, enhance product characteristics, enhance patient acceptability etc.
  • Pharmaceutically acceptable excipient(s) includes, but not limited to suspending agents, buffers (pH adjusting agents or pH modifying agent), preservatives, antioxidants, viscosity modifier or viscosity modifying agent, solubilizers, complexing agents, antifoaming agents, dispersing agent, sweeteners, flavour or flavouring agents, suitable vehicle, isotonizing agent, anticaking agent and any other excipient known to the art for making pharmaceutical composition.
  • a particular excipient may perform multiple roles in the pharmaceutical formulation, for example, it can act both as a preservative and/or as a pH adjusting agents.
  • the present invention is related to an oral liquid pharmaceutical composition comprising Cyclizine or its pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipient.
  • the present inventors have surprisingly found that the oral pharmaceutical composition comprising Cyclizine can be administered effectively in the children aged 6 years above and adults who are unable to swallow a solid dosage form. It is an object of the present invention to provide a stable oral liquid pharmaceutical composition comprising Cyclizine or pharmaceutically acceptable salt thereof.
  • the present invention is related to a oral liquid pharmaceutical composition
  • a oral liquid pharmaceutical composition comprising Cyclizine or pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipient, wherein the composition is stable for at least one month under storage condition of 25°C/60% RH and/or 30°C/65% RH and/or 40°C/75% and/or 2-8°C.
  • the storage conditions used in the present invention are 25°C/60% RH and/or 30°C/65% RH and/or 40°C/75% and/or 2-8°C.
  • the ‘storage condition of 25°C/60% RH’ means storage at a temperature of 25°C and 60% relative humidity.
  • the ‘storage condition of 30°C/65% RH’ means storage at a temperature of 30°C and 65% relative humidity
  • the ‘storage condition of 40°C/75% RH’ means storage at a temperature of 40°C and 75% relative humidity.
  • the ‘storage condition of 2-8°C’ means storage at a temperature of 2 to 8°C.
  • the oral liquid pharmaceutical composition is stable for at least two months, preferably for at least three months, preferably for at least four months, more preferably for at least five months under storage condition of 25°C/60% RH. In another embodiment of the present invention, the oral pharmaceutical composition is stable for at least six months under storage condition of 25°C/60% RH.
  • the oral liquid pharmaceutical composition is stable for at least two months, preferably for at least three months, preferably for at least four months, more preferably for at least five months under storage condition of 30°C/65% RH. In another embodiment of the present invention, the oral pharmaceutical composition is stable for at least six months under storage condition of 30°C/65% RH.
  • the oral liquid pharmaceutical composition is stable for at least two months, preferably for at least three months, preferably for at least four months, more preferably for at least five months under storage condition of 40°C/75% RH. In another embodiment of the present invention, the oral pharmaceutical composition is stable for at least six months under storage condition of 40°C/75% RH.
  • the oral liquid pharmaceutical composition is stable for at least two months, preferably for at least three months, preferably for at least four months, more preferably for at least five months under storage condition of 2-8°C. In another embodiment of the present invention, the oral pharmaceutical composition is stable for at least six months under storage condition of 2-8°C.
  • an invention provides a stable oral liquid pharmaceutical composition
  • a stable oral liquid pharmaceutical composition comprising: a) cyclizine or pharmaceutically acceptable salt thereof; b) preservative; c) viscosity modifier; d) anti- foaming agent; e) sweetener; and f) one or more pharmaceutically acceptable excipients.
  • an invention provides a stable oral liquid pharmaceutical composition
  • a stable oral liquid pharmaceutical composition comprising: a) Cyclizine or pharmaceutically acceptable salt thereof; b) preservative; c) viscosity modifying agent or solubilizer; d) sweetener; e) antifoaming agent; f) optionally dispersing agent or suspending agent; and g) one or more pharmaceutically acceptable excipient.
  • an invention provides a process for preparation of stable oral liquid pharmaceutical composition
  • a process for preparation of stable oral liquid pharmaceutical composition comprising; a) soaking viscosity modifier in vehicle; b) separately dissolving preservative and sweetener in vehicle and mixing to get clear colourless solution; c) adding and mixing antifoaming agent into above solution to get white coloured homogenous suspension; d) adding and dispersing Cyclizine HC1 in above suspension and mixing to get white coloured homogeneous suspension; e) adding and mixing step a) dispersion into above suspension to get white coloured suspension; f) adding and mixing flavor into above dispersion to get white coloured homogeneous dispersion; g) adding and mixing pH modifying agent get desired pH; and h) making up the volume with vehicle and mixing to get white coloured homogeneous dispersion.
  • an invention provides a process for preparation of stable oral liquid pharmaceutical composition
  • a process for preparation of stable oral liquid pharmaceutical composition comprising; a) soaking viscosity modifier in vehicle; b) adding and dissolving solubilizer in vehicle to get clear colourless solution; c) adding and dissolving Cyclizine HC1 into above solution to get clear colourless solution; d) adding and dissolving preservative and sweetener into above solution to get clear colourless dispersion; e) adding and dissolving viscosity modifier into above solution to get clear colourless solution; f) adding and mixing antifoaming agent into above dispersion to get white coloured homogeneous suspension; g) adding and dissolving suspending agent into above solution to get off white colour suspension; h) adding and mixing dispersing agent into above suspension to get white coloured homogeneous suspension; i) adding and mixing flavour into above suspension to get white coloured homogeneous suspension; j) adding and mixing pH modifying agent get desired pH; and k) making up the
  • Cyclizine as used herein comprises l-Diphenylmethyl-4-methylpiperazine with a molecular weight of 266.38. Further the term “Cyclizine” means all varieties or forms of Cyclizine including, but not limited to all pharmaceutically acceptable salts, esters, amides, isomers, stereo isomers, crystalline and amorphous forms. The preferred hydrochloride (HC1) salt is used.
  • the amount of Cyclizine in the composition of the invention may vary depending on the total volume of composition and the concentration of the other components.
  • the amount of Cyclizine according to the invention may be present at a concentration of from 0.01 to 15% w/v, and preferably from 0.05 to 12% w/v and more particularly from 0.1 to 10% w/v.
  • the one or more pharmaceutically acceptable excipient are selected from group consisting of buffers (pH adjusting agents), preservatives, antioxidants, solubilizers, complexing agents, antifoaming agents, sweeteners, flavouring agents, suitable vehicle, isotonizing agent, viscosity modifying agent, anticaking agent and any other excipient known to the art for making formulation.
  • buffers pH adjusting agents
  • preservatives antioxidants
  • solubilizers complexing agents
  • antifoaming agents sweeteners
  • flavouring agents suitable vehicle
  • isotonizing agent viscosity modifying agent
  • anticaking agent any other excipient known to the art for making formulation.
  • Suspending agents include, but are not limited to xanthan gum, gellan gum, guar gum, microcrystalline cellulose, sodium carbo xymethylcellulose, a mixture of carboxymethylcellulose sodium and microcrystalline cellulose, colloidal silicon dioxide, propylene glycol alginate, methylcellulose, hydroxypropyl methylcellulose (HPMC) and combinations thereof.
  • the suspending agent is a mixture of carboxymethylcellulose sodium and microcrystalline cellulose, sodium carboxymethylcellulose, xanthan gum and colloidal silicon dioxide.
  • the amount of the suspending agents in the formulation generally ranges from about 0.01 to 15% w/v, preferably about 0.01 to 12% w/v, and more particularly from about 0.1 to about 10% w/v.
  • Buffers/pH Adjuster which may be used, according to the present invention, include suitable buffers that are not chemically reactive with the other excipient, and which may be present in an amount sufficient to provide the desired degree of pH buffering.
  • a buffer system comprising of an aqueous mixture of an acid, wherein the acid is citric, succinic, tartaric, lactic, or phosphoric acid, and a base, wherein the base is sodium citrate dihydrate, sodium hydroxide, or disodium hydrogen phosphate, is for maintaining the pH in the range from 3 to 7.
  • Preservatives which may be used according to the present invention, include, but are not limited to, benzoic acid, sodium benzoate, potassium sorbate, cresol, cetrimide, citric acid and sodium citrate, and alkyl hydroxybenzoates (parabens).
  • the preservative is selected from an alkyl hydroxybenzoate, such as methyl hydroxybenzoate or methyl parahydroxybenzoate (MHB), ethyl hydroxybenzoate or ethyl parahydroxybenzoate (EHB), propyl hydroxybenzoate or propyl parahydroxybenzoate (PHB) (as base or sodium salt) or a combination thereof.
  • the amount of the preservatives in the formulation generally ranges from about 0.001 to 3% w/v, preferably about 0.01 to 2% w/v, and more particularly from about 0.01 to about 1.5% w/v.
  • Viscosity modifying agent or viscosity modifier which may be used according to the present invention, include, but are not limited to Xanthan Gum, Carboxymethylcellulose Sodium (Carmellose Sodium).
  • Solubilizers which may be used according to the present invention, include, but are not limited to polyhydric alcohol, ethanol, polyethylene glycol, non-ionic surfactant, an ionic surfactant, a hydrophilic polymer, cyclodextrin derivative such as 2-Hydroxypropyl-beta- cyclodextrin (HP Beta-CD) and a carbohydrate.
  • Dispersing agents which may be used according to the present invention, include, but are not limited to colloidal silicon dioxide.
  • Anti-foaming agent can be a silicone based antifoam such as Simethicone.
  • Antifoaming agent is preferably simethicone emulsion.
  • Antioxidants which may be used according to the present invention, include, but are not limited to sodium metabisulfate, ascorbic acid, sodium formaldehyde, sulfoxylate, or mixtures thereof.
  • Complexing agents which may be used according to the present invention, include, but are not limited to a-cyclodextrin, P-cyclodextrin, y-cyclodextrin and their derivatives such as, for example, hydroxypropyl- P-cyclodextrin.
  • Sweeteners or sweetening agents may be any natural or artificial sweetener.
  • natural sweeteners or sweetening agents these include, but are not limited to, glucose, fructose, invert sugar, sorbitol, sucrose, maltose, xylose, ribose, mannose, corn syrup solids, xylitol, mannitol, maltodextrins and mixtures thereof.
  • artificial sweeteners these include, but are not limited to, sucralose, aspartame and saccharin.
  • the artificial sweetener is sucralose.
  • the amount of the sweetener or sweetening agents in the formulation generally ranges from about 0.001 to 5% w/v, preferably about 0.01 to 4% w/v, and more particularly from about 0.01 to about 2% w/v.
  • Flavouring agents or flavour incorporated in the liquid formulation may be chosen from synthetic flavour oils and flavouring aromatics and/or natural oils, extracts from plant leaves, flowers, fruits, and so forth and combinations thereof.
  • Other useful flavors are vanilla, citrus oils, including lemon, orange, lime and grapefruit, and fruit essence, including apple, grape, banana, pear, peach, strawberry, raspberry, cherry, plum, pineapple, apricot, and so forth.
  • the amount of the flavouring agent or flavour in the formulation generally ranges from about 0.001 to 2% w/v, preferably about 0.01 to 1.5% w/v, and more particularly from about 0.01 to about 1% w/v.
  • the vehicle used in the formulation of the invention is selected from glycerin, propylene glycol, water or combination thereof.
  • the vehicle used in the formulation of the invention is preferably purified water, although other suitable water-containing (aqueous) vehicles known to the skilled person may also be used.
  • the amount of water can be present from about 70% to about 99% w/v of the liquid formulation.
  • the present invention related an oral liquid pharmaceutical composition comprising Cyclizine or pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipient.
  • liquid composition suitable for oral administration includes suspension, solution or the like and any combination thereof.
  • the stable oral liquid pharmaceutical composition of Cyclizine is in the form of a suspension.
  • the stable oral liquid pharmaceutical composition of Cyclizine is in the form of a solution.
  • the stable oral liquid pharmaceutical composition of Cyclizine is oral aqueous suspension or powder for oral suspension which meant to be administered after reconstitution in a suitable solvent.
  • the Cyclizine or pharmaceutical acceptable salt thereof has a particle size distribution D(90) less than about 250pm, less than about 220pm, less than about 200pm, preferably less than about 150pm, more preferably less than about 100pm.
  • the stable oral liquid pharmaceutical composition of Cyclizine is indicated in adults and in children aged above 6 years and for the treatment of nausea and vomiting symptoms associated with narcotic analgesics, general anaesthesia in the post-operative period, vertigo, Meniere’s disease, vestibular disturbance, motion sickness, radiotherapy-induced emesis in mastectomy patients.
  • the oral liquid pharmaceutical composition comprising Cyclizine or pharmaceutical acceptable salt thereof provides better palatability with increasing the patient compliance and patient acceptability towards the formulation.
  • the oral liquid pharmaceutical composition comprising Cyclizine or pharmaceutical acceptable salt thereof is administered two or three or four times daily.
  • the oral liquid pharmaceutical composition may be packaged within any type of pharmaceutically acceptable package, bottles, container depending upon the quantity of the final dosage form.
  • Example 3 to 5- Cyclizine Hydrochloride 50mg/5ml Oral Solution Example 3- Manufacturing Process: a) Add and dissolve 2-Hydroxypropyl-beta-cyclodextrin in 50% of total volume of purified water at the speed of 2500 -3500 RPM for 5 minutes to get clear colourless solution; b) Add and dissolve Cyclizine HC1 into above solution using silverson mixer at the speed of 2500 -3500 RPM for 10 minutes to get clear colourless solution; c) Add and dissolve sodium benzoate & sucralose into above solution using silverson mixer at the speed of 2500 -3500 RPM for 05 minutes to get clear colourless solution; d) Add and dissolve carmellose sodium into above solution using silverson mixer at the speed of 2500-3500 RPM for 30 minutes to get clear colourless dispersion; e) Add and mix simethicone 30% into above dispersion using silverson mixer at the speed of 2500-3500 RPM for 05 minutes to get white coloured homogeneous suspension; f
  • Example 4- Manufacturing Process a) Soak xanthan gum in 20% of total volume of purified water; b) Separately dissolve MHB, PHB & sucralose in 30% of total volume of purified water with using silverson mixer at the speed of 2000-3000 RPM for 15 minutes to get clear colourless solution; c) Add and mix simethicone 30% emulsion into above solution using silverson mixer at the speed of 2000-3000 RPM for 5 minutes to get white coloured homogeneous suspension; d) Add and disperse Cyclizine HC1 in above suspension and mix using silverson mixer at the speed of 2000-3000 RPM for 15 minutes to get white coloured homogeneous suspension; e) Add and mix step a) dispersion into above suspension using silverson mixer at the speed of 2000-3000 RPM for 45 minutes to get white coloured suspension; f) Add and mix orange flavor into above dispersion using silverson mixer at the speed of 2000-3000 RPM for 5 minutes to get white coloured homogeneous dispersion; g) Make 10% solution
  • Example 6 Stability study: Stability data of suspension formulation of example 1, packed in glass bottle is shown below.
  • Example 7 Stability study: Stability data of suspension formulation of example 2, packed in glass bottle is shown below.
  • Example 8 Stability study: Stability data of solution formulation of example’s 3-5, packed in glass bottle is shown below.

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  • Pharmacology & Pharmacy (AREA)
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Abstract

La présente invention concerne une composition pharmaceutique liquide orale comprenant de la cyclizine ou un sel pharmaceutiquement acceptable de celle-ci et un ou plusieurs excipients pharmaceutiquement acceptables, et concerne également le procédé de préparation de ladite composition qui est utilisé pour le traitement des nausées et des symptômes de vomissement.
PCT/IN2023/050586 2022-06-20 2023-06-20 Composition pharmaceutique orale de cyclizine ou d'un sel pharmaceutiquement acceptable de celle-ci Ceased WO2023248241A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202221035218 2022-06-20
IN202221035218 2022-06-20

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WO2023248241A1 true WO2023248241A1 (fr) 2023-12-28

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3184386A (en) * 1958-05-02 1965-05-18 Burroughs Wellcome Co Prolonged action medicinal tablets
WO2011150859A1 (fr) * 2010-06-04 2011-12-08 Comprehensive Drug Enterprises Ltd Formulations aqueuses orales de méclizine comprenant un agent aromatisant
IN201841019335A (fr) * 2018-05-23 2019-11-29

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3184386A (en) * 1958-05-02 1965-05-18 Burroughs Wellcome Co Prolonged action medicinal tablets
WO2011150859A1 (fr) * 2010-06-04 2011-12-08 Comprehensive Drug Enterprises Ltd Formulations aqueuses orales de méclizine comprenant un agent aromatisant
IN201841019335A (fr) * 2018-05-23 2019-11-29

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