+

WO2016038623A2 - Forme posologique pharmaceutique stable au goût masqué - Google Patents

Forme posologique pharmaceutique stable au goût masqué Download PDF

Info

Publication number
WO2016038623A2
WO2016038623A2 PCT/IN2015/000353 IN2015000353W WO2016038623A2 WO 2016038623 A2 WO2016038623 A2 WO 2016038623A2 IN 2015000353 W IN2015000353 W IN 2015000353W WO 2016038623 A2 WO2016038623 A2 WO 2016038623A2
Authority
WO
WIPO (PCT)
Prior art keywords
drug
pharmaceutical composition
water
solid phase
bitter
Prior art date
Application number
PCT/IN2015/000353
Other languages
English (en)
Other versions
WO2016038623A3 (fr
Inventor
Anwar Siraj DAUD
Shamsuddin JAMALUDDIN
Original Assignee
Zim Laboratories Limited
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 Zim Laboratories Limited filed Critical Zim Laboratories Limited
Publication of WO2016038623A2 publication Critical patent/WO2016038623A2/fr
Publication of WO2016038623A3 publication Critical patent/WO2016038623A3/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats

Definitions

  • the invention relates to taste masked stable pharmaceutical dosage forms and methods of making the same. Particularly, this invention relates to masking bitterness of drugs. This invention particularly illustrates masking bitterness of Ciprofloxacin and Sildenafil citrate as example.
  • Taste masking of bitter drugs is a problem persisting since a long time.
  • Des-quinolone group of medicines are one such group of medicines for which de-bittering is desired.
  • Many approached are used to achieve taste masking of bitter drugs.
  • Ismat et a! disclose a pharmaceutical composition in the form of a dry powder comprising particles of a readily water soluble drug which when solubilized has a bitter taste and which particles are treated so that upon addition of water thereto, the particles are rendered less soluble or form an in-situ precipitate suspended in the water and are essentially free of bitter taste, wherein said drug is rendered free of bitter taste without use or need for polymer or wax coating or microencapsulation.
  • the reduction in solubility of drug or precipitation of drug is achieved by including one or more pH modifying agents in the pharmaceutical composition which generate a required pH environment in water.
  • the said pH modifying agent is an alkaline agent and provides a pH of the suspension greater than the drug-pH in water or the pH modifying agent is an acidifying agent and provides a pH of the suspension lower than the drug-pH in water.
  • Sjoovist et al. disclose a method for preparing a dry powder for use as a pharmaceutical preparation which comprises mixing a pharmaceutically acceptable basic substance selected from the group consisting of sodium bicarbonate, disodium mono hydrogen phosphate, Dipotassium hydrogen phosphate, Trisodium citrate, magnesium dihydroxide and trizma with a bad tasting drug, said drug being in a form insoluble at high pH, and said basic substance being present in a mole ratio of basic substance to drug of 0.2-10, and.
  • a pharmaceutically acceptable basic substance selected from the group consisting of sodium bicarbonate, disodium mono hydrogen phosphate, Dipotassium hydrogen phosphate, Trisodium citrate, magnesium dihydroxide and trizma
  • encapsulating the mixture in a material consisting essentially of a water insoluble polymer selected from the group consisting of ethyl cellulose, polyvinyl acetate, polyvinyl chloride and a copolymer of dimethylaminoethyl methacrylate and methyl methacrylate, wherein the encapsulated material is present in an amount that allows bioavailability and which in combination with the basic substance is sufficient to mask the taste of the drug.
  • James et al disclose a composition comprising cefuroxime axetil in particulate form, the particles being provided with integral coatings of a lipid or a mixture of lipids which are insoluble in water and which serve to mask the bitter taste of cefuroxime axetil upon oral administration but which disperse or dissolve on contact with gastro-intestinal fluid.
  • Nishii et al discloses a coating method for spray-coating the surfaces of solid particles with a thermally melted wax for preparations for masking materials of unpleasant and bitter tastes.
  • Mapelli et al disclose a pharmaceutical formulation for oral administration comprising a core consisting essentially of a drug, said core being coated with a polymeric membrane which is soluble only at a pH of 5 or greater and an acidic compound mixed with the coated core for reducing or preventing the dissolution of the membrane in the oral cavity. The drug will be released only when the coated cores have passed through the stomach and reached the intestine where there is a pH equal to or greater than 5.
  • the polymer membrane provides taste masking qualities.
  • Ghanta et al (US 5,653,993) disclosed a taste masked, microencapsulated, nonsteroidal, anti-inflammatory, water-insoluble SAID drug material comprising individual microcapsules consisting essentially of NSAID drug particles and simultaneously coacervated cellulose acetate phthalate and gelatin microencapsulating wall materials having a high payload of active drug and characterized as free flowing, individual, taste-masked microcapsules in the substantial absence of microcapsule agglomerates and having a microcapsule particle size distribution ranging from about 25 to about 600 microns.
  • the invention comprises a solid phase pharmaceutical composition of a drug that tastes bitter when it is at its drug-pH, wherein the solid phase pharmaceutical composition comprises the drug the drug-pH of which is modified to a different pH to render it bitter-less or to render its bitterness substantially reduced to make its oral consumption bearable; the pH modified drug being obtained by exposing the drug to a pH modifier under conditions required for modifying the drug-pH to the different pH, and thereafter solidifying the composition containing the pH modified drug; the "drug-pH" being defined as the pH of water when the active form of the water soluble or partly water soluble drug is, respectively, dissolved or party dissolved in water.
  • the invention also comprises a method of making the same.
  • the invention also comprises a pharmaceutical composition constituted as suspension of the above mentioned solid phase pharmaceutical composition.
  • the solid phase pharmaceutical composition described above may be in the form of tablets, powder, granules or pellets.
  • the pH modifier may selected, one or more, from the group consisting of Magnesium Oxide. L- Arginine, L-Lysine, Sodium Citrate, sodium carbonate and magnesium hydroxide.
  • the process of making a composition also includes in-situ pH adjustment that is done in-situ during the step of granulation and drying of granules.
  • the pH adjusted drug is further adsorbed on an inert carrier/adsorbent.
  • the iinert adsorbent comprise selected from the group inorganic silicates and non-peril seeds.
  • Inorganic silicates on which adsorption is done may be selected one or more from the group consisting of Aluminium Magnesium Silicate, talc, Magnesium Tri-silicate. Any other equivalent adsorbents that provide the same function may also be used.
  • Adsorption on the inert carrier is made by layering or loading.
  • the pharmaceutical composition may further comprise pharmaceutically permitted excipients.
  • the excipients comprise, pharmaceutically permitted excipients including, without limitation, selected from a group comprising, one or more of sweeteners, flavors, colors and disintegrators.
  • the drugs selected for this invention includes any drug that is bitter tasting, is water soluble or partly water soluble and becomes bitter-less or with significantly reduced bitterness so that oral consumption becomes bearable when its drug-pH is altered. The alteration may either be towards acidic side or to basic side.
  • the invention is illustrated by using the Des-quinolone group of medicines, particularly Ciprofloxacin HCI and also by using Sidanafil Citrate.
  • the pharmaceutical composition of this invention is consumed orally either by direct oral administration or after constituting in a suspension by adding water before oral consumption.
  • compositions of Ismat et al that the composition was that each solid composition when constituted with appropriate amount of water produced a palatable suspension of the drug. However, it gelled upon standing for more than few hours. Hence, it was not possible to envisage making multi-dose bottles that can be used for more than one day for a reasonable number of days. Normally, a multi-dose bottle is considered as convenient from the view of cost as well as convenience. Hence, this defect needed to be overcome.
  • the solid composition is made by intimate mixing of the bitter drug and the pH modifier as powders and they should be allowed to come in contact with each other for a pH adjustment by addition of water only just prior to the use to get bitter-less suspension or substantially reduced bitterness suspension for oral consumption, making the drug and the pH modifier to react with each other to change the pH of the drug in the mixture and drying the same to make solid composition for filling up in bottles provided a composition which upon constituting a suspension by addition of water to the same provided a suspension that did not gel for up to at least 14 days.
  • This one single step provided a very practical method of getting bitter-less or substantially reduced bitterness compositions of bitter drugs that are normally bitter at the pH of their activity (drug-pH) when dissolved or partly dissolved in water.
  • the taste masked formulations of this invention are simple and less expensive because commonly available equipments can be used to make them, and special purpose equipment required for very fine grinding and intimate blending are not required.
  • the pH modified drug (Ciprofloxacin as illustrated here)
  • it is not soluble in water, hence it does not also taste bitter when orally consumed.
  • the drug is readily available for absorption in gastrointestinal tract because stomach has pH of about 1.2, at which pH of suspension, after oral administration, the pH of stomach brings back the drug to its "drug- pH” to make the drug soluble, hence, readily available for absorption in gastrointestinal tract.
  • drug-pH is used here for the purpose of this specification to mean the pH of water when the active form of the water soluble or partly soluble drug is, respectively, dissolved or partly dissolved in water.
  • This invention comprises a solid phase pharmaceutical composition of a drug that tastes bitter when it is at its drug-pH, wherein the solid phase pharmaceutical composition comprises the drug the drug-pH of which is modified to a different pH to render it bitter-less or to render its bitterness substantially reduced to make its oral consumption bearable; the pH modified drug being obtained by exposing the drug to a pH modifier under conditions required for modifying the drug-pH to the different pH, and thereafter solidifying the composition containing the pH modified drug; the "drug-pH" being defined as the pH of water when the active form of the water soluble or partly soluble drug is, respectively, dissolved or partly dissolved in water.
  • This invention also comprises a pharmaceutical composition constituted as suspension of a solid phase pharmaceutical composition in water wherein the solid phase pharmaceutical composition comprises of a drug that tastes bitter when it is at its drug-pH, and wherein the drug-pH of the drug is modified to a different pH to render it bitter-less or to render its bitterness substantially reduced to make its oral consumption bearable; the pH modified drug being obtained by exposing the drug to a pH modifier under conditions required for modifying the drug-pH to the different pH, and thereafter solidifying the omposition containing the pH modified drug; the "drug-pH" being defined as the pH of water when the active form of the water soluble or partly soluble drug is, respectively, dissolved or partly dissolved in water.
  • This invention also comprises a method of making the pharmaceutical composition of this invention.
  • the above said pharmaceutical composition is in the form of tablets, powder, granules or pellets meant for oral consumption or a suspension reconstituted from the tablets, powder, granules or pellets.
  • the pH adjusted drug in above described pharmaceutical compositions may be adsorbed on inert adsorbent.
  • the inert adsorbent may include, one or more of, without limitation, inorganic silicates and non-peril seeds.
  • the pharmaceutical composition of this is intended to be filled in bottles for reconstitution with water just before oral administration.
  • the pH adjustment is made such that the drug is not soluble in aqueous medium soluble form when it is in the oral cavity, leading to absence or substantial reduction in expression of its bitter taste; and the drug achieves its pH required for its activity when it gets past the oral cavity and enters the digestive tract.
  • the active form of the drug with drug-pH required for expression of its activity is never exposed to the taste buds and the bitterness is, thus, masked.
  • pH adjusted drug is also adsorbed on inert carrier/s.
  • Such pH adjusted drug adsorbed on inert carrier is in solid state, which is filled in bottles, or made into tablets or pellets into sachets for storage and transportation in market and is intended to be consumed by the user as chewable tablet, orodispersible tablet, as powder/pellets/granules filled in a sachet, or constituted as a suspension in water after opening the packing and contains one or several dosages. It is an embodiment of this invention that the reconstituted dosages of the pharmaceutical composition of this invention remain stable without gelling and also without loss of potency of the drug for a certain reasonable number of days after constitution as a suspension in water. After passing past the oral cavity, the drug consumed through the suspension gets adjusted to its active pH in the gastrointestinal tract depending on the location where it gets exposed to the contents of the gastro-intestinal tract to return to its drug- pH, gets absorbed and provides the intended activity.
  • composition described above may be in the form of chewable pellets for direct oral administration or in the form of chewable tablets for oral administration.
  • the method of making the pharmaceutical composition of this invention comprise use of one or more of commonly available less expensive equipment used widely in the art for drug layering or drug loading.
  • the equipment may comprise, one or more of, without limitation, a Fluid bed coater, a conventional coating pan, a fluid bed processer, a centrifugal granulator or the like.
  • adsorption of the pH adjusted drug on an inert carrier is made by layering or loading.
  • the inert carrier may be non-peril seeds made up of sugars.
  • the drugs loaded belong to des-quinolone group of medicines.
  • the invention is not by any means limited to this illustration; and the scope of this invention and relevant claims extends to all instances wherein the claimed method leads to masking the bitter taste of the drugs.
  • the pharmaceutical composition of this invention comprises pharmaceutically permitted excipients.
  • the excipients used may include, without limitation, one or more of sweeteners, flavors, color, disintegrator and adsorbent.
  • the adsorbents may include inorganic silicates.
  • the inorganic silicates may include, one or more of, without limitation, Aluminium Magnesium Silicate, taic, Magnesium Tri-silicate etc.
  • the pH modifier may include, without limitation, Magnesium Oxide. L- Arginine, L-Lysine, Sodium Citrate, magnesium hydroxide and the like.
  • the process of making the composition comprises a step of in-situ pH adjustment by bringing the drug in contact with a pH modifier under conditions that would modify the drug- pH to make it bitter-less or for reducing the bitterness substantially and solidifying the composition thereafter.
  • the pH adjusted drug may be layered by loading on an inert carrier.
  • the inert carrier may be non-peril seeds or any equivalent alternative for them.
  • the drug is pH adjusted and adsorbed prior to layering/loading on the pellets of the inert carrier which are then filled into bottles.
  • the pellets filled in the bottle are intended to be constituted with water into a suspension by the consumer immediately before consumption/administration.
  • the process of making a composition also includes in-situ pH adjustment via granulation and drying of granules.
  • the pH adjusted drug in granule form is either filed in bottles or may be made as powder, granules, pellets, or compressed into tablets by tableting process known in the art, for making tablets.
  • the tablets may be consumed orally as tablets or may be dissolved in water and the solution/suspension in water is consumed.
  • the in situ pH adjustment is done prior to bottle filling and the material filled in the bottle is a solid form and not a liquid form.
  • the material filled in the bottle is a solid form and not a liquid form.
  • Solid dosage forms containing pH adjusted drug that is adsorbed on inert carrier prepared as per this inventive method is bitter-less and the drug remains stable.
  • the solid dosage form may be granules, pellets, tablets. Pellets & Tablets for chewab!e & Orodispersible use are bitter-less and stable.
  • composition(s)/preparation(s) of this invention is/are patient friendly.
  • Example 1 Granules, ready to fill into bottles for constituting as oral suspension in water just before use.
  • Ciprofloxacin HCI & Magnesium Oxide were put in a granulator, mixed thoroughly and granulated with water. Further, rest of the ingredients were added one by one and thoroughly mixed, water was added as per requirement to achieve pH adjustment of the drug to make it bitter-less or with significantly reduced bitterness, the granules were dried at 50°C for 12 Hours and 20g of granules were filled per bottle. The formulation was in the form of dry syrup. During use, this is directed to be constituted into a suspension with water to get 60ml oral palatable suspension. The reconstituted suspension contains 12 dosages and the suspension remains stable for consumption up to 14 days at least.
  • Example 2 Example 2
  • Pellets Ready to fill into bottles for constituting as oral suspension in water just before use
  • Ciprofloxacin HCI was dissolved in sufficient water, further Sucralose & color was dissolved, and thereafter all other ingredients were dispersed one after another while stirring in suitable vessel to achieve pH adjustment of the drug to make it bitter-less or with significantly reduced bitterness.
  • This suspension so prepared was layered on globules of sugar in fluid bed coater at 60°C inlet air temperature with suitable velocity of air to fluidize the sugar globules, pellets so prepared were filled into bottle. Oral suspension is made just before consumption.
  • Example 3 Example 3:
  • Pellets prepared in experiment no. 2 were also suitable to fill into sachets to use as Oro- dispersible pellets.
  • Formulation was prepared by dry blending the ingredients mentioned in following table with the proportions as mentioned below in the table (Example 5 of Ismat et al (WO2003077842A2).
  • Each tablet contains ingredients given in table 7 below.
  • Sildenafil citrate and magnesium oxide granulate with water so as to change the pH of Sildenafil citrate to make it bitter-less or substantially free from bitterness and dry the granules at 45°C.
  • Sildenafil Citrate was partly dissolved by dispersing in sufficient water, further dispersed magnesium oxide in it so as to change the pH of Sildenafil citrate to make it bitter-less or substantially free from bitterness. Further add sucralose, silicon dioxide, croscarmellose sodium, dry at 60°C. Further dried granules add silicon dioxide and strawberry flavor and mix sugar. In this preparation pH is adjusted by magnesium oxide to make Sildenafil Citrate bitter-less.
  • Bottles are constituted as suspension with water.
  • the suspension had substantially reduced bitterness; was only slightly bitter. However, within 24 hours there is a gel formation in the bottle which clearly shows the pH adjustment of the suspension outside the bottle and solidification thereafter prior to filling in the bottle is necessary to avoid gelling after constituting the contents of the bottle into a suspension by adding water.
  • Example No. 9 The below formulation is as per example 5 of Ismat et al, however, process of making the same is as per example 2 given above for this invention
  • Ciprofloxacin and L-arginin were dissolved in water separately and mixed together for pH adjustment. After Keeping as such for next 8Hours, then suspended / dissolved Sodium bisulphite, silicon dioxide, spartum / Sodium CMC, Methyl Paraben and other ingredients. The mass was dried at 50", the dried mass was passed through 14# sieve ' and filled into bottles. After constitution of the bottled solids into a suspension by addition of water, no gel formation observed within 24 hours.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention comprend une composition pharmaceutique en phase solide d'un médicament qui possède un goût amer lorsqu'il est à son pH de médicament, ladite composition pharmaceutique en phase solide comprenant le médicament dont le pH de médicament est modifié en un pH différent pour le rendre non amer ou réduire sensiblement son amertume afin de rendre sa consommation par voie orale supportable. Le médicament à pH modifié est obtenu par exposition à un modificateur de pH dans les conditions requises pour modifier le pH de médicament au pH différent, puis solidification de la composition contenant le médicament au pH modifié. Le "pH de médicament" est défini comme le pH de l'eau lorsque la forme active du médicament soluble dans l'eau ou partiellement soluble est respectivement dissous ou partiellement dissous dans l'eau. La composition pharmaceutique en phase solide décrite ci-dessus peut être sous forme de comprimés, de poudre, de granules ou de pastilles, qui sont consommées par voie orale en tant que solides ou après constitution dans une suspension par addition d'eau.
PCT/IN2015/000353 2014-09-10 2015-09-09 Forme posologique pharmaceutique stable au goût masqué WO2016038623A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2890/MUM/2014 2014-09-10
IN2890MU2014 2014-09-10

Publications (2)

Publication Number Publication Date
WO2016038623A2 true WO2016038623A2 (fr) 2016-03-17
WO2016038623A3 WO2016038623A3 (fr) 2016-06-09

Family

ID=55459679

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2015/000353 WO2016038623A2 (fr) 2014-09-10 2015-09-09 Forme posologique pharmaceutique stable au goût masqué

Country Status (1)

Country Link
WO (1) WO2016038623A2 (fr)

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7101572B2 (en) * 2001-12-07 2006-09-05 Unilab Pharmatech, Ltd. Taste masked aqueous liquid pharmaceutical composition
US20040180091A1 (en) * 2003-03-13 2004-09-16 Chang-Yi Lin Carbonated hydroxyapatite-based microspherical composites for biomedical uses

Also Published As

Publication number Publication date
WO2016038623A3 (fr) 2016-06-09

Similar Documents

Publication Publication Date Title
US5639475A (en) Effervescent microcapsules
JP2552785B2 (ja) 水中にて迅速に懸濁する医薬組成物
JP4129995B2 (ja) 水性媒体に迅速に懸濁する医薬組成物
KR101141508B1 (ko) 판토프라졸 복합 미립자 제형
US6214386B1 (en) Prompt-release oral pharmaceutical compositions for extemporaneous suspensions
ES2215223T3 (es) Suspensiones liquidas de sabor enmascarado.
KR100288523B1 (ko) 향미차폐제약조성물
ES2739888T3 (es) Composiciones y comprimidos farmacéuticos con recubrimiento compresible y métodos de fabricación
ES2701443T3 (es) Formulación aglutinante de fosfato para ingestión simple
ES2219360T3 (es) Formulaciones liquidas farmaceuticas de sabor enmascarado.
JP2005527508A (ja) 経口デリバリー用急速溶融多粒子製剤
JPH0460968B2 (fr)
CN102215822A (zh) 基于γ-羟基丁酸的新型组合物
EP0411952A2 (fr) Rotogranulations et enrobages pour masquer le goût pour la préparation de comprimés pharmaceutiques à mâcher
US20100183730A1 (en) High dose composition of ursodeoxycholic acid
JPH0259515A (ja) 鎮痛活性及び抗炎症活性を有し、優れた嗜好性をもち、且つ粘膜に刺激作用のない経口投与用製薬組成物
WO2004087111A1 (fr) Compositions pharmaceutiques orales a gout masque
AU2015389109B2 (en) Enteric-coated pellets containing a proton pump inhibitor
WO2011101734A2 (fr) Poudre à goût masqué pour compositions en suspension de méthylprednisolone
ES2202915T3 (es) Composiciones farmaceuticas que comprenden zafirlukast.
ES2336588T3 (es) Formas farmaceuticas de liberacion rapida para antibioticos.
CN102579398A (zh) 一种具有掩盖药物不良口味作用的肠溶微囊及制备方法
WO2016038623A2 (fr) Forme posologique pharmaceutique stable au goût masqué
EP1949900B1 (fr) Formulation solide à libération contrôlée pour l'administration orale en tant que sachet monodose et son procédé de préparation
US20130115282A1 (en) Polyvalent polymeric matrix for modified release solid oral preparations and method of preparation thereof

Legal Events

Date Code Title Description
NENP Non-entry into the national phase in:

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 15839790

Country of ref document: EP

Kind code of ref document: A2

点击 这是indexloc提供的php浏览器服务,不要输入任何密码和下载