WO2016024928A1 - Taste masked paracetamol formulations - Google Patents

Taste masked paracetamol formulations Download PDF

Info

Publication number
WO2016024928A1
WO2016024928A1 PCT/TR2015/000305 TR2015000305W WO2016024928A1 WO 2016024928 A1 WO2016024928 A1 WO 2016024928A1 TR 2015000305 W TR2015000305 W TR 2015000305W WO 2016024928 A1 WO2016024928 A1 WO 2016024928A1
Authority
WO
WIPO (PCT)
Prior art keywords
paracetamol
pharmaceutical
taste
pharmaceutical composition
active ingredient
Prior art date
Application number
PCT/TR2015/000305
Other languages
French (fr)
Inventor
Serap ODABAŞI
Ürün KANDEMIRER
Tuba GIDERÖZ
Original Assignee
Bi̇ofarma İlaç Sanayi̇ Ve Ti̇caret A.Ş.
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 Bi̇ofarma İlaç Sanayi̇ Ve Ti̇caret A.Ş. filed Critical Bi̇ofarma İlaç Sanayi̇ Ve Ti̇caret A.Ş.
Priority to TR2016/18030T priority Critical patent/TR201618030T2/en
Publication of WO2016024928A1 publication Critical patent/WO2016024928A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007Effervescent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds

Definitions

  • the invention relates to taste masked pharmaceutical formulations comprising paracetamol as an active pharmaceutical ingredient having bitter taste.
  • Oral administration forms may be tablet, capsule, suspension, syrup, effervescent tablet, orodispersible tablet, chewable tablet...etc.
  • Pharmaceutical products such as effervescent tablets, granules, powder, sachet, suspension are preferred in terms of patient compliance, especially for children and elders having swallowing difficulties. In these forms, it is necessary to improve the taste since the active ingredient is taken in a dissolved form.
  • use of aroma, sweeteners and amino acids, polymer coating, preparation of microgranules, use of ion exchange resins, cylcodextrin, lipid, lecithin or derivatives, polymer membranes, surfactant are preferred.
  • flavour and aroma alone is not able to mask active ingredient having intense bitter taste, especially if the active ingredient amount is high in the formulation on the other hand using coating methods or preparation of microgranules changes the release properties of the drug and also makes the production process more laborious and costly.
  • Paracetamol also known as acetaminophen and chemically named N-acetyl-p- aminophenol, is a non-prescription analgesic and antipyretic. It can be used in combination with other active ingredients in the cold. It can be prescribed in combination with opioid derivatives to provide potent analgesic effect. Products containing paracetamol are marketed in the form of tablet, capsule, suspension, effervescent, intravenous and intramuscular form. Paracetamol can be used in adults in the dose range of 500 mg to 1000 mg. The maximum daily dose for adults is 4000 mg. Paracetamol is recommended as the first-line drug for geriatric patients over 50 years old and for the pain and aches seen in influenza.
  • paracetamol As well as the preferred route of paracetamol administration is oral, paracetamol is also well-known with its bitter taste.
  • ParacetamoPs characteristic feature is its searing taste and leaving an unpleasant taste in the throat after swallowing. In the case of contact with mouth or throat mucosa, an unpleasent taste is felt.
  • WO20040871 11 numbered international patent application describes an oral taste masked pharmaceutical compositions which includes a core having an active ingredient coated with a mixture of polymeric film forming binders and inorganic carriers. Also provided is a processes for preparing the oral taste masked pharmaceutical composition.
  • WO2004052345 numbered international patent application describes coating compositions for taste masking including a copolymer of acrylate and methacrylate with a quaternary ammonium group in combination with sodium carboxymethylcellulose and a polyvinyl alcohol- polyethylene glycol copolymer.
  • EP 1276469 numbered European patent application provides a coating composition that masks the undesirable taste of a pharmaceutically active ingredient with a coating composition including polyvinyl acetate, a dimethylaminoethyl methacrylate and neutral methacrylic acid ester and an alkaline modifier.
  • Alkaline modifier can be basic amino salts, talc, ammonium oleate, meglumine, trimethylamine, calcium silicate, aluminum magnesium silicate.
  • EP0556057 numbered European patent application discloses oral suspension of paracetamol where taste is masked with an effective amount of water with flavors and sweeteners. This invention is not sufficient especially for high dose paracetamol suspensions. On the other hand use of high dose sweeteners is not preferred for diabetics.
  • WOl 995000133 numbered international patent application discloses bitter taste masked acetaminophen composition.
  • This a>mposition includes asuspension agent and sweetening agents.
  • the suspension agent can be sodium alginate in case the concentration of the sweetening agent is preferably at least about 25 weight percent of the paracetamol composition.
  • the paracetamol concentration to total composition is maximum %10. But, when high concentration paracetamol compositions considered using high concentration of sweeteners as mentioned in the application is not prefered especially for diabetic patients.
  • This invention is about formulation where bitter taste of pharmaceutical product with paracetamol having bitter taste is masked, inhibited or/and unpleasent aftertaste in mouth, throat prohibited. This invention is also about bitter taste masked formulation of pharmaceutical product with high concentration of paracetamol.
  • This invention is also about easy, cheap manufacturing process where bitter taste of pharmaceutical product including paracetamol masked.
  • This invention is about pharmaceutical products including paracetamol with bitter taste and pharmaceutical products this bitter taste is masked.
  • taste masking is understood to mean herein a perceived reduction, prevention of an undesirable and unpleasant taste that would otherwise be present.
  • bitter taste is understood to mean herein undesirable and unpleasant bitter taste within the mouth that would otherwise be present.
  • aftertaste left in throat is understood to mean herein undesirable and unpleasant aftertaste in throat that would otherwise be present.
  • This invention provides a formulation where unpleasent taste of pharmaceutical active ingredient is masked. Additionally, there is no aftertaste, perceived taste .
  • paracetamol Paracetamol can be used as pharmaceutical acceptable salt, hdyrate, solvate or esther.
  • This invention discloses use of metallic salts in the formulations to mask, inhibit taste of paracetamol.
  • Metallic salts can be alkaline and/or alkaline earth metallic salts or combinations.
  • Metallic salts, alkaline and/or alkaline earth metallic salts or salt expressions described within the invention are alkaline and/or earth alkaline metallic salts or mixtures.
  • Alkaline and/or alkaline earth metallic salts used to mask bitter taste of pharmaceutical formulation of paracetamol can be any of or mixture of at least one cation salt or mixture of cation salts selected from sodium, potasium, magnesium, calcium. In a prefered embodiment of this invention sodium chloride is used.
  • Alkaline/ earth alkaline metallic salt or metallic salt mixture ratio to active ingredient is prefered to be within 0,05 and 0,2 in this invention.
  • Ratio of metallic salt or metallic salt mixture to active ingredient is prefered to be 0, 1.
  • alkaline and/or earth alkaline metallic salt or metallic salt mixture is used in combination with at least one sweetener to mask the taste.
  • Sweeteners used within the invention are frequently used sweteners in pharmaceutical industry.
  • any sweetener or mixture of sweeteners described here can be used. This invention is not limited to sweeteners described here.
  • the ratio of sweetener or sweetener combination to active ingredient is prefered to be between 0,4 to 0,8. In a prefered embodiment sweetener or sweetener combination ratio to active ingredient is between 0,45 to 0,6.
  • flavors are used in combination with sweeteners. Flavors used within this invention are flavors used in pharmaceutical industry. Prefered flavors of this invention can be any of or mixture of vanilla, fumaric acid, malic acid, maltol, menthol, lemon. This invention is not limited to flavors described here.
  • Formulation disclosed in this invention include at least one pharmaceutically acceptable excipient in addition to paracetamol and taste masking agents.
  • any of or mixture of disintegrant, viscosity increaser, filler, diluent, drier, surfactant, stabilizer, lubricant, wetting agent, glidant, pH regulator, taste regulator, emulsifier, solvent, antioxidant, antifoaming agent, preservative, coloring agent, complexation agent is used. This invention is not limited to excipients described here.
  • oral pharmaceutical form of taste masked paracetamol formulation can be any of tablet, rapidly disintegrating tablet, effervescent tablet, orally disintegrating tablet, chewable tablet, oral solution, syrup, suspension.
  • Pharmaceutical suitable excipients in pharmaceutical industry are used for the required pahramaceutical form.
  • paracetamol is used however subject of this invention can be used for all products containing paracetamol in combination with other active ingredients.
  • paracetamol can be combined with any of or mixture of antihistaminics, antitussives, antibiotics, expectorants, decongestants, diuretics, gastrointestinal agents, bronchodilators, sleep regulators and other analgesics.
  • antihistaminics can be chlorpheniramine, brompheniramine, de chlo heniramine, oxolamine, doxolamine, acrivastine, astemizole, azatadine, azelastine, cetyrizine, ketotifen, lodoxamide, loratidine, levocabastine, mequitazine, oxatomide, setastine, mechitasine, temelastine, terfenadine, triprolidine, tripelenn amine, cyproheptadine, hydroxyzine, pyrilamine, promethazine, diphenhydramine, fexofenadine, phenyltoloxamine; antitussives can be dextromethorphan hydrobromide, clofedanol, carbetapentane, caramiphen, noskapine, diphenhydramine, codeine, hydrocodone, hydromo h ⁇ nan
  • paracetamol in this invention can be used in any concentration and also in formulations of high concentration paracetamol.
  • "High concentration” as used here in means using paracetamol single or in combination with other active ingredients at least in concentration of 325 mg in the pharmaceutical product.
  • effervescent formulation can be manufactured according to methods decribed in the description or according to known technolgy.
  • effervescent formulation can be manufactured according to methods decribed in the description or according to known technolgy.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

This inventions is about taste masked pharmaceutical compositions of paracetamol having bitter taste by using metallic salts.

Description

TASTE MASKED PARACETAMOL FORMULATIONS
DESCRIPTION
Technical Field
The invention relates to taste masked pharmaceutical formulations comprising paracetamol as an active pharmaceutical ingredient having bitter taste.
Background of the Invention
Active ingredients are generally implemented orally. Oral administration forms may be tablet, capsule, suspension, syrup, effervescent tablet, orodispersible tablet, chewable tablet...etc. Pharmaceutical products such as effervescent tablets, granules, powder, sachet, suspension are preferred in terms of patient compliance, especially for children and elders having swallowing difficulties. In these forms, it is necessary to improve the taste since the active ingredient is taken in a dissolved form. To reduce or inhibit the bitter taste, in the phannaceutical technology, use of aroma, sweeteners and amino acids, polymer coating, preparation of microgranules, use of ion exchange resins, cylcodextrin, lipid, lecithin or derivatives, polymer membranes, surfactant are preferred.
The use of flavour and aroma alone is not able to mask active ingredient having intense bitter taste, especially if the active ingredient amount is high in the formulation on the other hand using coating methods or preparation of microgranules changes the release properties of the drug and also makes the production process more laborious and costly.
Paracetamol, also known as acetaminophen and chemically named N-acetyl-p- aminophenol, is a non-prescription analgesic and antipyretic. It can be used in combination with other active ingredients in the cold. It can be prescribed in combination with opioid derivatives to provide potent analgesic effect. Products containing paracetamol are marketed in the form of tablet, capsule, suspension, effervescent, intravenous and intramuscular form. Paracetamol can be used in adults in the dose range of 500 mg to 1000 mg. The maximum daily dose for adults is 4000 mg. Paracetamol is recommended as the first-line drug for geriatric patients over 50 years old and for the pain and aches seen in influenza.
As well as the preferred route of paracetamol administration is oral, paracetamol is also well-known with its bitter taste. ParacetamoPs characteristic feature is its searing taste and leaving an unpleasant taste in the throat after swallowing. In the case of contact with mouth or throat mucosa, an unpleasent taste is felt. There is a need to maske, inhibit the bitter taste of paracetamol given in disintegrated form during oral use such as syrup, effervescent tablet, oral disintegrating tablet. Even today, there is user's complication about bitter taste left i mouth or throat after use of paracetamol effervescent tablet. It is mentioned that even in paracetamol syrups having strong sweeteners bitter taste couldn't masked.
Different methods and fonnulations evaluated in order to inhibite or mask bitter taste of paracetamol in prior art. In the state of prior art, WO20040871 11 numbered international patent application describes an oral taste masked pharmaceutical compositions which includes a core having an active ingredient coated with a mixture of polymeric film forming binders and inorganic carriers. Also provided is a processes for preparing the oral taste masked pharmaceutical composition.
In the state of prior art, WO2004052345 numbered international patent application describes coating compositions for taste masking including a copolymer of acrylate and methacrylate with a quaternary ammonium group in combination with sodium carboxymethylcellulose and a polyvinyl alcohol- polyethylene glycol copolymer.
In the state of prior art, EP 1276469 numbered European patent application provides a coating composition that masks the undesirable taste of a pharmaceutically active ingredient with a coating composition including polyvinyl acetate, a dimethylaminoethyl methacrylate and neutral methacrylic acid ester and an alkaline modifier. Alkaline modifier can be basic amino salts, talc, ammonium oleate, meglumine, trimethylamine, calcium silicate, aluminum magnesium silicate.
In the state of prior art, EP0556057 numbered European patent application discloses oral suspension of paracetamol where taste is masked with an effective amount of water with flavors and sweeteners. This invention is not sufficient especially for high dose paracetamol suspensions. On the other hand use of high dose sweeteners is not preferred for diabetics.
In the state of prior art, WOl 995000133 numbered international patent application discloses bitter taste masked acetaminophen composition. This a>mposition includes asuspension agent and sweetening agents.The suspension agent can be sodium alginate in case the concentration of the sweetening agent is preferably at least about 25 weight percent of the paracetamol composition. The paracetamol concentration to total composition is maximum %10. But, when high concentration paracetamol compositions considered using high concentration of sweeteners as mentioned in the application is not prefered especially for diabetic patients.
None of the above documents describes masking the bitter taste of paracetamol by addition of metal salts to formulations together with sweeteners and flavors. Above documents are not sufficient especially for masking bitter taste of pharmaceutical products with high concentration of paracetamol. In order to mask bitter taste especially coating method is prefered in the prior art. Coating method increase production cost and time. Beside formulations described in above documents prefere to use high concentration of sweeteners. Unpleasent aftertaste of paracetamol in mouth and throat is partially masked by using high concentration of sweeteners but not sufficient. Summary of the Invention
This invention is about formulation where bitter taste of pharmaceutical product with paracetamol having bitter taste is masked, inhibited or/and unpleasent aftertaste in mouth, throat prohibited. This invention is also about bitter taste masked formulation of pharmaceutical product with high concentration of paracetamol.
This invention is also about easy, cheap manufacturing process where bitter taste of pharmaceutical product including paracetamol masked.
Detailed Description of the Invention
This invention is about pharmaceutical products including paracetamol with bitter taste and pharmaceutical products this bitter taste is masked.
Bulus icerisinde ''tadin diizeltilmesi" ifadesi, aksi belirtilmedigi siirece, arzu edilmeyen veya hos olmayan bir tada iliskin algidaki azalma veya algmin giderilmesi anlammda kullanilmaktadir. Bulus icerisinde "aci tat" (bitterness) ifadesi, aksi belirtilmedigi siirece, agizda hissedilen arzu edilmeyen veya ho§ olmayan aci tat anlammda kullanilmaktadir. Bulus icerisinde "bogazda biraktigi tat" veya "bogazda kalan tat" (aftertaste) ifadeleri, aksi belirtilmedigi siirece, bogazda kalan arzu edilmeyen veya hos olmayan tat anlammda kullanilmaktadir.
As set forth within the invention, taste masking is understood to mean herein a perceived reduction, prevention of an undesirable and unpleasant taste that would otherwise be present. As set forth within the invention, bitter taste is understood to mean herein undesirable and unpleasant bitter taste within the mouth that would otherwise be present. As set forth within the invention, aftertaste left in throat is understood to mean herein undesirable and unpleasant aftertaste in throat that would otherwise be present. This invention provides a formulation where unpleasent taste of pharmaceutical active ingredient is masked. Additionally, there is no aftertaste, perceived taste . In this invention described and taste masked pharmaceutical active ingredient is paracetamol. Paracetamol can be used as pharmaceutical acceptable salt, hdyrate, solvate or esther.
This invention discloses use of metallic salts in the formulations to mask, inhibit taste of paracetamol. Metallic salts can be alkaline and/or alkaline earth metallic salts or combinations. Metallic salts, alkaline and/or alkaline earth metallic salts or salt expressions described within the invention are alkaline and/or earth alkaline metallic salts or mixtures. Alkaline and/or alkaline earth metallic salts used to mask bitter taste of pharmaceutical formulation of paracetamol can be any of or mixture of at least one cation salt or mixture of cation salts selected from sodium, potasium, magnesium, calcium. In a prefered embodiment of this invention sodium chloride is used.
The ratio of alkaline or earth alkaline metallic salt or mixture of metallic salt to active ingredient is important in the invention. Alkaline/ earth alkaline metallic salt or metallic salt mixture ratio to active ingredient is prefered to be within 0,05 and 0,2 in this invention. Ratio of metallic salt or metallic salt mixture to active ingredient is prefered to be 0, 1.
In this invention alkaline and/or earth alkaline metallic salt or metallic salt mixture is used in combination with at least one sweetener to mask the taste. Sweeteners used within the invention are frequently used sweteners in pharmaceutical industry. As sweetener dextrose, saccharin, saccharin salt, acesulfame, sucralose, aspartame, sucrose, fructose, levulose, glucose, galactose, maltose, sorbitol, xylitol, maize syrup, lactitol, glycerol, maltitol, sodium cyclamate, lactose, mannitol, maltol can be used. For this invention any sweetener or mixture of sweeteners described here can be used. This invention is not limited to sweeteners described here. In this invention, the ratio of sweetener or sweetener combination to active ingredient is prefered to be between 0,4 to 0,8. In a prefered embodiment sweetener or sweetener combination ratio to active ingredient is between 0,45 to 0,6. In a preferred embodiment of this invention flavors are used in combination with sweeteners. Flavors used within this invention are flavors used in pharmaceutical industry. Prefered flavors of this invention can be any of or mixture of vanilla, fumaric acid, malic acid, maltol, menthol, lemon. This invention is not limited to flavors described here.
Formulation disclosed in this invention include at least one pharmaceutically acceptable excipient in addition to paracetamol and taste masking agents. In a prefered embodiment any of or mixture of disintegrant, viscosity increaser, filler, diluent, drier, surfactant, stabilizer, lubricant, wetting agent, glidant, pH regulator, taste regulator, emulsifier, solvent, antioxidant, antifoaming agent, preservative, coloring agent, complexation agent is used. This invention is not limited to excipients described here.
In this invention, oral pharmaceutical form of taste masked paracetamol formulation can be any of tablet, rapidly disintegrating tablet, effervescent tablet, orally disintegrating tablet, chewable tablet, oral solution, syrup, suspension. Pharmaceutical suitable excipients in pharmaceutical industry are used for the required pahramaceutical form. In this invention, paracetamol is used however subject of this invention can be used for all products containing paracetamol in combination with other active ingredients. In a preferred embodiment paracetamol can be combined with any of or mixture of antihistaminics, antitussives, antibiotics, expectorants, decongestants, diuretics, gastrointestinal agents, bronchodilators, sleep regulators and other analgesics. In prefered embodiment antihistaminics can be chlorpheniramine, brompheniramine, de chlo heniramine, oxolamine, doxolamine, acrivastine, astemizole, azatadine, azelastine, cetyrizine, ketotifen, lodoxamide, loratidine, levocabastine, mequitazine, oxatomide, setastine, mechitasine, temelastine, terfenadine, triprolidine, tripelenn amine, cyproheptadine, hydroxyzine, pyrilamine, promethazine, diphenhydramine, fexofenadine, phenyltoloxamine; antitussives can be dextromethorphan hydrobromide, clofedanol, carbetapentane, caramiphen, noskapine, diphenhydramine, codeine, hydrocodone, hydromo hίnan, fominobene, benzonatat; decongestant pseudoephedrine, phenyeplirine, phenylpropanolamine, ephedrine; expectorant guaifenesin, glyceryl guaiacolate, terpin hydrate, ammonium hydrochloride, N-acetylcystein, bromhexine, ambroxol, domiodol, propanediol derivative; other anlgesics acetyl salicilic acid, indomethazine, ibuprofen, naproxen, sulindac, fenoprofen, diclofenac, proxicam, benzydamine, nabumetone, codeine, oxycodone, hydrocodone, nimesulide, celecoxib, methyloxasole derivative, meloxieam, flurbiprofen, carprofen, tiaprofenic acid, ketoprofen, ketorolac, etodolac, butalbital, tramadol; gastrointestinal agent atropine, clidinium, dicyclomine, aluminum hydroxide, bizmuth subcalicylate, bizmuth subcitrate, simethicone, calsium carbonate, magaldrate, cimetidine, famotidine, nizatidine, ranitidine, phenolphtalein, sucralfate, mekasantrol, metoclopramide, omeprazole, diphenoxylate, loperamide; other grups caffeine, pamabrom; bronchodilator terbutaline, aminophylline, pinerin, isoprenaline, metaproterenol, bitolterol, theophylline, salbutamol; sleep regulators, metalotonin, estazolam, Zolpidem, from promethazine group or pharmaceutical acceptable salts or their combination.
In this invention paracetamol can be used in any concentration and also in formulations of high concentration paracetamol. "High concentration" as used here in means using paracetamol single or in combination with other active ingredients at least in concentration of 325 mg in the pharmaceutical product.
Below examples are to describe the invention better however does not limit the scope of the invention. Examples
Example 1: Effervescent Tablet 1
Figure imgf000009_0001
Above described effervescent formulation can be manufactured according to methods decribed in the description or according to known technolgy.
Example 2: Effervescent Tablet 2
Figure imgf000009_0002
Example 3: Effervescent Tablet 3
Figure imgf000010_0001
Above described effervescent formulation can be manufactured according to methods decribed in the description or according to known technolgy.
According to common concepts described within the application many applications may be developed with the subject of the invention "Taste Masked Paracetamol Formulations". Invention is not limited to examples described within the application but mainly according to claims.

Claims

1. Taste masked oral pharmaceutical formulations where active ingredient is paracetamol and metallic salts are used.
Paracetamol taste masked composition comprising metallic salts.
2. The pharmaceutical composition wherein at least one of sodium chloride, magnesium chloride, calcium chloride, potassium chloride or their mixture is used as metallic salts.
3. The pharmaceutical composition according to claim 2 where sodium chloride is used as metallic salt.
4. The pharmaceutical composition according to any of above claims where ratio of metallic salt to active ingredient is between 0,05 to 0,2.
5. Pharmaceutical product according any of the above claims where pharmaceutical form is effervescent tablet, suspension, syrup, orally disintegrating tablet or chewable tablet.
6. Pharmaceutical composition according to any of the above claims where one or more active ingredients used in combination with paracetamol.
7. Pharmaceutical composition according to claim 6 where any of or mixture of active ingredient selected from antihistaminic, antitussive, expectorant, bronchodilator, decongestant, antibiotic group used in combination with paracetamol.
8. Pharmaceutical composition according to Claim 7 where paracetamol is combined with at least one of or mixture of any active ingredient selected from oxolamine, pseudoephedrine and chlorpheniramine.
9. Pharmaceutical products comprising pharmaceutical composition according to any of above claims.
PCT/TR2015/000305 2014-08-14 2015-08-13 Taste masked paracetamol formulations WO2016024928A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
TR2016/18030T TR201618030T2 (en) 2014-08-14 2015-08-13 Tastedly corrected paracetamol formulations.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR201409474 2014-08-14
TR2014/09474 2014-08-14

Publications (1)

Publication Number Publication Date
WO2016024928A1 true WO2016024928A1 (en) 2016-02-18

Family

ID=54065431

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2015/000305 WO2016024928A1 (en) 2014-08-14 2015-08-13 Taste masked paracetamol formulations

Country Status (2)

Country Link
TR (1) TR201618030T2 (en)
WO (1) WO2016024928A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11202756B2 (en) 2018-04-18 2021-12-21 Shilpa Medicare Limited Oral disintegrating film compositions of paracetamol

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0203768A2 (en) * 1985-05-31 1986-12-03 Warner-Lambert Company A therapeutic effervescent composition and a method of preparing the same
EP0556057A1 (en) 1992-02-14 1993-08-18 McNEIL-PPC, INC. Aqueous pharmaceutical suspension for pharmaceutical actives
WO1995000133A1 (en) 1993-06-25 1995-01-05 Ibah, Inc. Taste-masked acetaminophen suspensions and methods of making the same
EP1276469A2 (en) 2000-04-20 2003-01-22 Bristol-Myers Squibb Company Taste masking coating composition
WO2004052345A1 (en) 2002-12-11 2004-06-24 Ranbaxy Laboratories Limited Coating composition for taste masking coating and methods for their application and use
WO2004087111A1 (en) 2003-04-04 2004-10-14 Ranbaxy Laboratories Limited Oral taste masked pharmaceutical compositions
US20070249727A1 (en) * 2006-04-21 2007-10-25 The Proctor & Gamble Company Compositions and kits useful for treatment of respiratory illness
WO2013175511A1 (en) * 2012-05-24 2013-11-28 V.B. Medicare Pvt. Ltd. Taste masked pharmaceutical compositions

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0203768A2 (en) * 1985-05-31 1986-12-03 Warner-Lambert Company A therapeutic effervescent composition and a method of preparing the same
EP0556057A1 (en) 1992-02-14 1993-08-18 McNEIL-PPC, INC. Aqueous pharmaceutical suspension for pharmaceutical actives
WO1995000133A1 (en) 1993-06-25 1995-01-05 Ibah, Inc. Taste-masked acetaminophen suspensions and methods of making the same
EP1276469A2 (en) 2000-04-20 2003-01-22 Bristol-Myers Squibb Company Taste masking coating composition
WO2004052345A1 (en) 2002-12-11 2004-06-24 Ranbaxy Laboratories Limited Coating composition for taste masking coating and methods for their application and use
WO2004087111A1 (en) 2003-04-04 2004-10-14 Ranbaxy Laboratories Limited Oral taste masked pharmaceutical compositions
US20070249727A1 (en) * 2006-04-21 2007-10-25 The Proctor & Gamble Company Compositions and kits useful for treatment of respiratory illness
WO2013175511A1 (en) * 2012-05-24 2013-11-28 V.B. Medicare Pvt. Ltd. Taste masked pharmaceutical compositions

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11202756B2 (en) 2018-04-18 2021-12-21 Shilpa Medicare Limited Oral disintegrating film compositions of paracetamol

Also Published As

Publication number Publication date
TR201618030T2 (en) 2018-09-21

Similar Documents

Publication Publication Date Title
US11406712B2 (en) Phenylephrine-containing liquid formulations
US9744133B2 (en) Enhanced stability of novel liquid compositions
EP2351554B1 (en) Enhanced stability phenylephrine liquid compositions
CZ365998A3 (en) System for supplying substances per os
WO2016024928A1 (en) Taste masked paracetamol formulations
US20060198856A1 (en) Ibuprofen suspension stabilized with docusate sodium
EP2861236B1 (en) Pharmaceutical composition containing phosphate binding polymer

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 15760301

Country of ref document: EP

Kind code of ref document: A1

DPE1 Request for preliminary examination filed after expiration of 19th month from priority date (pct application filed from 20040101)
WWE Wipo information: entry into national phase

Ref document number: 2016/18030

Country of ref document: TR

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 15760301

Country of ref document: EP

Kind code of ref document: A1