WO2010107342A2 - Agent et procédé pour une ingestion facilitée de formes posologiques solides - Google Patents

Agent et procédé pour une ingestion facilitée de formes posologiques solides Download PDF

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Publication number
WO2010107342A2
WO2010107342A2 PCT/RU2010/000123 RU2010000123W WO2010107342A2 WO 2010107342 A2 WO2010107342 A2 WO 2010107342A2 RU 2010000123 W RU2010000123 W RU 2010000123W WO 2010107342 A2 WO2010107342 A2 WO 2010107342A2
Authority
WO
WIPO (PCT)
Prior art keywords
solid dosage
dosage forms
compositions
agent
drug
Prior art date
Application number
PCT/RU2010/000123
Other languages
English (en)
Russian (ru)
Other versions
WO2010107342A3 (fr
Inventor
Василий Иванович ШАХОВ
Иван Егорович МАЛИНИН
Марина Вячеславна ОХОТНИКОВА
Original Assignee
Shakhov Vasily Ivanovich
Malinin Ivan Egorovich
Okhotnikova Marina Vyacheslavna
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 Shakhov Vasily Ivanovich, Malinin Ivan Egorovich, Okhotnikova Marina Vyacheslavna filed Critical Shakhov Vasily Ivanovich
Publication of WO2010107342A2 publication Critical patent/WO2010107342A2/fr
Publication of WO2010107342A3 publication Critical patent/WO2010107342A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin

Definitions

  • the invention relates to medicine and can be used for oral administration of solid dosage forms.
  • a known method of receiving a solid dosage form (patent US7306109), which uses a container with a cap. There is liquid in the container. The solid dosage form is placed on the outer surface of the cap, thus, the solid dosage form is taken at the same time as the liquid.
  • Water and agent provide comfortable ingestion of solid dosage forms, which uses the method of simultaneous washing of solid dosage forms.
  • the main effect when using water and a drug (patent US6277395) - facilitating the sliding of a solid dosage form in the cavity of the gastrointestinal tract - is achieved in case of joint promotion of water or a drug (patent US6277395) and a solid dosage form in the cavity of the gastrointestinal tract.
  • the use of the instantaneous method of drinking solid dosage forms in the case of using water or means is sufficient to achieve comfortable swallowing.
  • An object of the invention is to increase the safety of oral administration of solid dosage forms.
  • the technical result is achieved when using means for washing solid dosage forms containing water, structure-forming substances based on polysaccharides in an amount of more than 0.05 and not more than 0.08 weight fractions, characterized by a viscosity in the range of more than 25 and not more than 3000 cPoise at a temperature of 20 degrees Celsius.
  • the technical result is achieved by using the method of drinking solid dosage forms, characterized by fractional administration of the above funds, while receiving the solid dosage form is carried out in the second or
  • the inventive tool contains water, structure-forming substances based on polysaccharides in an amount of more than 0.05 and not more than 0.08 weight fractions (more than 5.0 wt.% And not more than 8.0 wt%), characterized by a viscosity in the range of more than 25 cPoise and not more than 3,000 cPoise at a temperature of 20 degrees Celsius (more than 5 cPoise and not more than PO cPaise at a temperature of 37 degrees Celsius) (experiment N ° 1).
  • the use of the claimed drug occurs at room temperature, the technical result is achieved in the stomach cavity, where the average fasting temperature is 37 degrees Celsius (www.dr.dugatov / pitapie / l l.htm), in this regard, the tool is characterized by a viscosity at a temperature of 20 degrees Celsius and 37 degrees Celsius.
  • Compositions containing structure-forming substances based on polysaccharides in an amount of 0.08 weight fractions or more (8.0 wt.% And more) are of little use for use as a detergent, since at a temperature of 20 degrees Celsius (the temperature at which consumption) have a fluidity that prevents swallowing (experiment N ° 1,3).
  • the method of fractional washing means taking the first portion of the claimed drug (without taking a solid dosage form) and taking a second or subsequent portion of the claimed drug for drinking in combination with taking a solid dosage form.
  • Reception of the first portion of the claimed drug (30 - 150 ml) (without taking a solid dosage form) is aimed at forming the first preparative layer of the claimed drug in the stomach cavity, in which, during the second or subsequent administration of the claimed drug (30 - 150 ml) (in combination with solid dosage form) will be a solid dosage form.
  • compositions of the claimed means for washing solid dosage forms provides the dissolution of solid dosage forms in the stomach either on the surface or in the thickness of the volume of the composition of the claimed funds, excluding the contact of the solid dosage form with the mucous membranes of the stomach (experiment
  • solid dosage form in particular refers to various solid dosage forms intended for oral use (powders, tablets, capsules) having different specific gravities, which is important when choosing the composition of the claimed drug at the time of using one or another solid dosage form.
  • solid dosage forms are conventionally divided into “light” (for example, “Antigrippin” powder elements) and “heavy” (for example, Amoxiclav tablet).
  • compositions of the claimed means which provide a solution to the claimed technical problem in cases of using "heavy” solid dosage forms, provide a solution to the claimed technical problem in cases of using "light” solid dosage forms. It is also true that the compositions of the claimed means, which provide a solution to the claimed technical problem in cases of using "light” solid dosage forms, do not in all cases provide a solution to the claimed technical problem in cases of using "heavy” solid dosage forms, since "heavy" solid dosage forms are drowning in the formulations of the claimed drug, in which "light” solid dosage forms are not drowning.
  • compositions of the claimed means containing structure-forming substances based on polysaccharides in an amount of more than 0.05 and not more than 0.08 weight fractions (more than 5.0 wt.% And not more than 8.0 wt%), in the case of applying a "light" solid dosage form, and the compositions of the claimed funds containing structure-forming substances based on polysaccharides in an amount of more than 0.07 and not more than 0.08 weight fractions (more than 7.0 wt.% and not more than 8.0 wt %) in the case of the use of a "heavy" solid dosage form.
  • water is used, structure-forming substances containing polysaccharides of plant, animal, bacterial, synthetic and semi-synthetic origin (thickeners, gelling agents): starch and its modifications, cellulose and its modifications, pectins, agaroids, carrageenans, gums, its alginic acid derivatives and other plant origin; gelatin and other animal origin; xanthan gum and other bacterial origin; water-soluble polyvinyl alcohols and their esters and other synthetic origin; approved for use in the food industry in dosages that are safe for the human body.
  • thickeners, gelling agents starch and its modifications, cellulose and its modifications, pectins, agaroids, carrageenans, gums, its alginic acid derivatives and other plant origin; gelatin and other animal origin; xanthan gum and other bacterial origin; water-soluble polyvinyl alcohols and their esters and other synthetic origin; approved for use in the food industry in dosages that are safe for the human body.
  • SUBSTITUTE SHEET (RULE 26) the quantities are mixed in proportions leading to the formation of the claimed funds, in which the content of structure-forming substances based on polysaccharides in the volume of the claimed funds is in the range of more than 0.05 and not more than 0.08 weight fractions (more than 5.0 wt.% and not more than 8 , 0 wt%).
  • the resulting mixture with constant stirring is heated to 100 degrees Celsius, cooled to room temperature, after which the product is ready for use.
  • stabilizers To improve consumer properties, stabilizers, preservatives, brighteners, colorants, flavoring and aromatic additives used in the food industry, emulsifiers, opacifiers, fillers, natural products in any combination in dosages that are safe for human health can be added to the claimed product.
  • compositions of the claimed funds To obtain the compositions of the claimed funds, the compositions of the funds (patent US6277395) and the control composition, food starch is used as a structure-forming substance, high-precision electronic scales are used to obtain the necessary mass of the structure-forming substance, insulin syringes to obtain the required exact volume of distilled water.
  • compositions of the funds containing 1 wt.% And 5 wt.% Structure-forming substances and compositions of the claimed funds containing 5.1 wt.%, 7 wt.%, 7.1 wt.%, 7.9 wt.% Structure-forming substances.
  • a control composition containing 8 wt% starch a product is formed that is not suitable for drinking due to low fluidity at 20 degrees Celsius,
  • the device viscometer "Fungilab premium H” determines the viscosity of the obtained compounds at a temperature of 20 degrees Celsius and 37 degrees Celsius.
  • the content of the structure-forming substance in the composition of the agent (patent US6277395) in an amount of 1 wt.% And 5 wt.% Leads to the formation of compositions with a viscosity of 2 c Poise and 25 c Poise at a temperature of 20 degrees Celsius, respectively, and 1 c Poise and 5 c Poise at a temperature of 37 degrees Celsius, respectively.
  • the content of the structure-forming substance in the compositions of the claimed agent in the amount of 5.1 wt.%, 7 wt.%, 7.1 wt.%, 7.9 wt.% Leads to the formation of compositions with a viscosity of 28 c Poise, 1895 c Poise, 2178 c Poise, 2997 c Poise at a temperature of 20 degrees Celsius respectively 11 cPoise, 74 cPoise, 82 cPoise and 109 cPoise at a temperature of 37 degrees Celsius, respectively.
  • 100 ml of various compositions are poured through a tube with a diameter of 2 cm: 100 ml of water in the first model, 100 ml of the composition of the product (US6277395 patent) containing 1 wt% starch in the second model, and 100 ml of the composition in the third model
  • SUBSTITUTE SHEET (RULE 26) (patent US6277395) containing 5 wt.% starch
  • 100 ml of the composition of the claimed agent containing 5.1 wt.% starch
  • 100 ml of the composition of the inventive agent containing 7 wt.% starch
  • 100 ml of the composition of the claimed agent containing 7.1 wt.% starch
  • compositions of the funds (patent US6277395), the compositions of the claimed funds is taking solid dosage forms. Reception of powder “Antigrippin” and tablets “Amoxiclav” occurs combined. Each model contains two solid dosage forms (powder and tablet). As a result, in the first model containing water, in the second and third models (containing the formulations of the agent (patent US6277395)), the elements of the powder “Antigrippin” and the tablet “Amoxiclav” fell on the walls of the bag (on the simulated mucous membranes).
  • the elements of the Antigrippin powder were thicker than the volume of the compositions of the claimed drug, the Amoxiclav tablet dropped onto the walls of the packet (on the simulated mucous membranes).
  • Stage 3 of the experiment 30 minutes after the modeled fractional administration of solid dosage forms in the stomach models, the position in the space of solid dosage forms did not change significantly, solid dosage forms dissolved.
  • the method of fractional washing of solid dosage forms is used.
  • Solid dosage forms are administered at room temperature.
  • the following solid dosage forms of various specific gravities are used (Antigrippin powder, Analgin tablet, Amoxiclav tablets), in combination with five different formulations of the claimed drug containing 5.1 wt.%, 7 wt.%, 7.1 wt.
  • the first volunteer uses the first composition of the claimed drug in combination with Antigrippin powder (a "light” solid dosage form)
  • the second volunteer uses the second composition and a tablet "Analgin” ("moderate” solid drug vennaya form)
  • third, fourth, fifth volunteer using compositions comprising 7.1 wt%, 7.9 wt%, 8 wt% of starch and tablet "Amoksiklav” ( “heavy” solid dosage form).
  • the viscosity of the formulations is proportional to the severity of the solid dosage form.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne le domaine de la médecine et peut être utilisée pour l'administration orale de formes posologiques solides. Le but de cette invention est de conférer plus de sécurité lors de l'administration orale de formes posologie solides. L'agent pour une ingestion facilitée de formes posologies solides contient de l'eau, des substances formant une structure à base de polysaccharides dans une quantité comprise entre 0,05 et 0,08 fractions en poids et est caractérisé en ce que sa viscosité est comprise entre 25 et 3000 cP à une température de 20 °C. Le procédé pour une ingestion facilitée de formes posologiques solides se caractérise par une administration espacée de l'agent précité, à savoir au cours d'une deuxième prise ou au cours des prises suivantes.
PCT/RU2010/000123 2009-03-19 2010-03-19 Agent et procédé pour une ingestion facilitée de formes posologiques solides WO2010107342A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU2009109791/15A RU2393846C1 (ru) 2009-03-19 2009-03-19 Средство для запивания твердых лекарственных форм и способ запивания твердых лекарственных форм
RU2009109791 2009-03-19

Publications (2)

Publication Number Publication Date
WO2010107342A2 true WO2010107342A2 (fr) 2010-09-23
WO2010107342A3 WO2010107342A3 (fr) 2010-11-11

Family

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Family Applications (1)

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PCT/RU2010/000123 WO2010107342A2 (fr) 2009-03-19 2010-03-19 Agent et procédé pour une ingestion facilitée de formes posologiques solides

Country Status (2)

Country Link
RU (1) RU2393846C1 (fr)
WO (1) WO2010107342A2 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2155585C2 (ru) * 1998-03-13 2000-09-10 Пятигорская государственная фармацевтическая академия Лекарственная форма для детей, обладающая противовоспалительным и жаропонижающим действием
US6277395B1 (en) * 1998-07-31 2001-08-21 Ryukakusan Co. Ltd. Swallowing-assistive drink
US20030170291A1 (en) * 2002-03-05 2003-09-11 Landau Steven M. System and method of administering pharmaceuticals and nutraceuticals as part of a beverage container

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2155585C2 (ru) * 1998-03-13 2000-09-10 Пятигорская государственная фармацевтическая академия Лекарственная форма для детей, обладающая противовоспалительным и жаропонижающим действием
US6277395B1 (en) * 1998-07-31 2001-08-21 Ryukakusan Co. Ltd. Swallowing-assistive drink
US20030170291A1 (en) * 2002-03-05 2003-09-11 Landau Steven M. System and method of administering pharmaceuticals and nutraceuticals as part of a beverage container

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
SUKHININ D. ET AL. LEKARSTVA I EDA-PROTIVNIKI VSEGDA, [Online] 2005, pages 1 - 2 Retrieved from the Internet: <URL:http://users.i.com.ua/~s_oracul/skazka_41.htm> *

Also Published As

Publication number Publication date
WO2010107342A3 (fr) 2010-11-11
RU2393846C1 (ru) 2010-07-10

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