FR2624012A1 - Novel pharmaceutical compositions having a hypnotic action based on chloral hydrate - Google Patents

Novel pharmaceutical compositions having a hypnotic action based on chloral hydrate Download PDF

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FR2624012A1
FR2624012A1 FR8716993A FR8716993A FR2624012A1 FR 2624012 A1 FR2624012 A1 FR 2624012A1 FR 8716993 A FR8716993 A FR 8716993A FR 8716993 A FR8716993 A FR 8716993A FR 2624012 A1 FR2624012 A1 FR 2624012A1
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pharmaceutical compositions
compositions according
chloral hydrate
chloral
new pharmaceutical
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FR2624012B1 (en
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Francois Dietlin
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FDB STE CIVILE RECH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (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)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention relates to the field of therapeutic chemistry, and more especially to the pharmaceutical field. It relates to novel pharmaceutical compositions presented in the form of gelatin capsules containing a hypnotic amount of chloral suspended or dissolved in a high-viscosity solvent. The novel compositions according to the invention are more stable and better tolerated.

Description

NOUVELLES COMPOSITIONS PHARMACEUTIQUES A ACTION
HYPNOTIQUE A BASE D'HYDRATE DE CHLORAL
La présente invention se rapporte à de nouvelles compositions pharmaceutiques à action hypnotique.NEW ACTION PHARMACEUTICAL COMPOSITIONS
HYPNOTIC BASED ON CHLORAL HYDRATE
The present invention relates to new pharmaceutical compositions with hypnotic action.

Elle concerne plus particulièrement des compositions pharmaceutiques à base de chloral manifestant une action prolongée et une tolérance améliorée.It relates more particularly to pharmaceutical compositions based on chloral, manifesting a prolonged action and improved tolerance.

Elle se rapporte spécifiquement à des compositions pharmaceutiques à action hypnotique, caractérisées en ce qu'elles renferment une quantité hypnotique de chloral et un véhicule inertenon toxique de forte viscosité dans lequel le principe actif est dissous ou mis en suspension.It relates specifically to pharmaceutical compositions with hypnotic action, characterized in that they contain a hypnotic amount of chloral and an inert non toxic carrier of high viscosity in which the active principle is dissolved or suspended.

D'une maniere préférée, les compositions pharmaceutiques selon l'invention se présentent sous forme de capsules molles dans lesquelles la suspension ou solution de principe actif est répartie. Le véhicule de forte viscosité est un véhicule visqueux, à température ordinaire, comme par exemple un solvant huileux d'origine minérale ou végétale tel que l'huile d'olive, l'huile d'arachide, l'huide de paraffine, l'huile de vaseline ou un mélange de plusieurs huiles ; une silicone liquide comme la diméthicone ou la siméthicone ; un polymère de glycol comme le polyéthylèneglycol 600, le polyéthylèneglycol 800 ou le polyéthylèneglycol 1200 ; un glycol comme l'éthylèneglycol, le propylèneglycol ou le glycol. Les solvants aqueux contenant moins de 5 % d'eau sont également possibles, tels un mélange PEG 4GO-eau-éthanol ou eau-propylèneglycol. Preferably, the pharmaceutical compositions according to the invention are in the form of soft capsules in which the suspension or solution of active principle is distributed. The high viscosity vehicle is a viscous vehicle, at ordinary temperature, such as for example an oily solvent of mineral or vegetable origin such as olive oil, peanut oil, paraffin oil, petrolatum oil or a mixture of several oils; a liquid silicone such as dimethicone or simethicone; a glycol polymer such as polyethylene glycol 600, polyethylene glycol 800 or polyethylene glycol 1200; a glycol such as ethylene glycol, propylene glycol or glycol. Aqueous solvents containing less than 5% water are also possible, such as a PEG 4GO-water-ethanol or water-propylene glycol mixture.

La quantité de chloral par prise unitaire varie de 200 mg à 600 mg. Elle est de préférence comprise entre 250 mg et 500 mg.The amount of chloral per unit dose varies from 200 mg to 600 mg. It is preferably between 250 mg and 500 mg.

Le chloral ou plus précisement l'hydrate de chloral a pour désignation chimique exacte trichloroéthanal ou aldéhyde éthylique tricolore. Sa formule chimique est

Figure img00020001
Chloral or more precisely chloral hydrate has the exact chemical designation trichloroethanal or tri-colored ethyl aldehyde. Its chemical formula is
Figure img00020001

C'est un agent hypnotique utilisé depuis près de cent trente ans. Il fond à basse température (F=560) et se volatilise facilement. En solution, le chloral est décrit comme caustique pour les muqueuses et susceptible d'occasionner des vomissements. C'est pourquoi, on trouve dans la littérature l'indication qu'on doit l'employer en solution diluée. De même, on trouve dans la littérature l'indication que ce produit est dangereux en cas d'ulcère gastrique, qu'il est contre-indiqué chez les cardiaques et qu'il convient de ne l'employer qu'à faibles doses et de façon très prudente chez l'enfant et le vieillard.It is a hypnotic agent used for almost one hundred and thirty years. It melts at low temperature (F = 560) and volatilizes easily. In solution, chloral is described as caustic for the mucous membranes and likely to cause vomiting. This is why, we find in the literature the indication that it should be used in dilute solution. Similarly, there is an indication in the literature that this product is dangerous in case of gastric ulcer, that it is contraindicated in cardiac patients and that it should only be used in low doses and very cautiously in children and the elderly.

Toutes ces limitations dans l'emploi du chloral ont conduit à un abandon progressif de cet agent thérapeutique, pourtant excellent hypnotique ou inducteur du sommeil.All these limitations in the use of chloral have led to a gradual abandonment of this therapeutic agent, however excellent hypnotic or inducing sleep.

La présente invention a donc pour objet de fournir au thérapeute moderne une nouvelle fc me d'administration du chloral dans laquelle le principe actif est peu susceptible de se volatiliser et qui assure une meilleure tolérance du principe actif.The object of the present invention is therefore to provide the modern therapist with a new form of chloral administration in which the active principle is unlikely to volatilize and which ensures better tolerance of the active principle.

On a pu constater que contrairement aux préparations galéniques anciennes, telles que le sirop de chloral à 5 % de chloral, les compositions pharmaceutiques selon l'invention sont sensiblement plus actives et permettent de réduire la posologie La préparation la plus utilisée est la capsule molle renfermant 0,500 g de chloral et la posologie journalière est ae 1 à 4 capsules par jour. La diminution ce la posologie qui est ainsi réalisée diminue la fréquence ôes effets seconsaires ou des réactions d'intolérance. It has been observed that, unlike old galenic preparations, such as chloral syrup with 5% chloral, the pharmaceutical compositions according to the invention are significantly more active and make it possible to reduce the dosage. The most used preparation is the soft capsule containing 0.500 g of chloral and the daily dosage is ae 1 to 4 capsules per day. The reduction in the dosage which is thus achieved decreases the frequency of side effects or intolerance reactions.

Le sommeil est ainsi obtenu chez des sujets insomniaques au bout de 15 à 20 minutes et dure de 6 à 8 heures.Sleep is thus obtained in insomniac subjects after 15 to 20 minutes and lasts from 6 to 8 hours.

Les compositions pharmaceutiques selon l'invention trouvent donc un emploi thérapeutique dans le traitement des troubles du sommeil soit pour amener le sommeil, soit pour le réendormissement de sujets dont la période de sommeil est courte.The pharmaceutical compositions according to the invention therefore find therapeutic use in the treatment of sleep disorders either for inducing sleep or for re-sleeping in subjects whose sleep period is short.

L'invention comprend aussi un procédé d'obtention des compositions pharmaceutiques à action hypnotique qui consiste en ce que l'on met en solution ou en suspension l'hydrate de chloral dans un véhicule à forte viscosité et répartit le mélange ainsi formé dans des capsules molles en gélatine.The invention also includes a process for obtaining pharmaceutical compositions with hypnotic action which consists in dissolving or suspending the chloral hydrate in a high viscosity vehicle and distributing the mixture thus formed in capsules. soft gelatin.

L'hydrate de chloral se dissout aisément dans l'eau, dans le propylèneglycol, les polymères d'éthylèneglycol. On obtient avec de tels solvants une solution. L'hydrate de chloral se dissout peu dans les huiles et dans les silicones liquides.Chloral hydrate easily dissolves in water, in propylene glycol, ethylene glycol polymers. A solution is obtained with such solvents. Chloral hydrate dissolves little in oils and in liquid silicones.

Il se forme alors une suspension. Gn peut rendre cette suspension plus stable par addition d'agents inertes comme la silice, le kieselguhr ou l'oxyde de- titane.A suspension then forms. Gn can make this suspension more stable by adding inert agents such as silica, kieselguhr or titanium oxide.

Les solutions ou suspensions pourront le cas échéant être additionnées d'agents de conservation ou de stabilisation.The solutions or suspensions may if necessary be added with preservatives or stabilizers.

Elles peuvent, en outre, être colorées.They can also be colored.

Les exemples suivants illustrent l'invention. Ils ne la limitent en aucune façon
EXEMPLE I
Capsules mclles à C,500 g de chloral(hydrate)
. hydrate de chloral 500 g
. huile de silicone 75 g
huile de paraffine 125 g
. acide sorbique 4,50 g
pour 1.000 capsules molles.The following examples illustrate the invention. They do not limit it in any way
EXAMPLE I
Single capsules at C, 500 g chloral (hydrate)
. chloral hydrate 500 g
. silicone oil 75 g
paraffin oil 125 g
. sorbic acid 4.50 g
per 1,000 soft capsules.

EXEMPLE II
Capsules molles à C,500 g de chloral (hydrate)
. hydrate de chloral 500 g
huile d'olive 40 g
. huile de maïs 150 g
. gallate d'isopropyle 7g
Pour 1.000 capsules molles
EXEMPLE III
Capsules molles à 0,250 g de chloral (hydrate)
. hydrate de chloral 250 g
. polymère d'éthylèneglycol de poids
moléculaire 800 (PEG 800) 125 g
. éthanol 10 g
. eau 10 g
. sorbate de potassium 4 g
pour 1.000 capsules molles
EXEMPLE IV
Capsules molles à 0,375 g de chloral (hydrate)
. hydrate de chloral 350 g
. siméthicone 150 g
. oxyde de titane 2,50 g
. silice colloïdale 7,50 g
. gallate d'isopropyle 2 g
pour 1.000 capsules molles. EXAMPLE II
Soft capsules at C, 500 g of chloral (hydrate)
. chloral hydrate 500 g
olive oil 40 g
. corn oil 150 g
. isopropyl gallate 7g
Per 1,000 soft capsules
EXAMPLE III
Soft capsules with 0.250 g of chloral (hydrate)
. chloral hydrate 250 g
. weight ethylene glycol polymer
molecular 800 (PEG 800) 125 g
. ethanol 10 g
. water 10 g
. potassium sorbate 4 g
per 1,000 soft capsules
EXAMPLE IV
Soft capsules with 0.375 g of chloral (hydrate)
. chloral hydrate 350 g
. simethicone 150 g
. titanium oxide 2.50 g
. colloidal silica 7.50 g
. isopropyl gallate 2 g
per 1,000 soft capsules.

Claims (6)

REVENDICATIONS La présente invention a pour objet 1. De nouvelles compositions pharmaceutiques à action hypnotique caractérisées en ce qu'elles renferment une quantité hypnotique d'hydrate de chloral et un véhicule inerte non toxique de forte viscosité dans lequel le principe actif est dissout ou mis en suspension.CLAIMS The present invention relates to 1. New pharmaceutical compositions with hypnotic action characterized in that they contain a hypnotic amount of chloral hydrate and an inert non-toxic vehicle of high viscosity in which the active principle is dissolved or put in suspension. 2. De nouvelles compositions pharmaceutiques selon la2. New pharmaceutical compositions according to the revenoication 1, caractérisée en ce que la solution ou revenoication 1, characterized in that the solution or suspension d'hydrate de chloral est répartie en capsules chloral hydrate suspension is divided into capsules de gélatine molles. soft gelatin. 3. De nouvelles compositions pharmaceutiques selon la3. New pharmaceutical compositions according to the revendication 1 ou la revendication 2, dans lesquelles la claim 1 or claim 2, in which the teneur en principe actif varie de 2ûû à 6û0 mg. content of active ingredient varies from 2û to 6û0 mg. Il. De nouvelles compositions pharmaceutiques selon l'une des He. New pharmaceutical compositions according to one of the revendications 1 à 3, dans lesquelles la teneur en claims 1 to 3, wherein the content of principe actif varie de 250 à 500 mg par prise unitaire. active ingredient varies from 250 to 500 mg per unit dose. 5. Les nouvelles compositions pharmaceutiques selon l'une des5. The new pharmaceutical compositions according to one of the revendications 1 à 4, dans lesquelles le véhicule de forte claims 1 to 4, in which the vehicle of strong viscosité est une huile minérale ou végétale, une silicone viscosity is a mineral or vegetable oil, a silicone liquide, un glycol ou un polymère de glycol. liquid, glycol or glycol polymer. 6. Les nouvelles compositions pharmaceutiques selon l'une des6. The new pharmaceutical compositions according to one of revendications 1 à 5, dans lesquelles le véhicule de forte claims 1 to 5, wherein the vehicle of strong viscosité contient moins de 5 X d'eau.  viscosity contains less than 5 X of water. 7. Un procédé d'obtention des compositions pharmaceutiques7. A process for obtaining pharmaceutical compositions selon l'une des revendications 1 à 5, dans lequel on met according to one of claims 1 to 5, in which one puts en solution ou en suspension dans un véhicule de forte  in solution or in suspension in a heavy vehicle viscosit l'hydrate de chloral et répartit le mélange viscosit the chloral hydrate and distribute the mixture ainsi forme dans des capsules molles en gélatine. thus formed in soft gelatin capsules. 6. Utilisaticn des compositions pharmaceutiques obtenues6. Use of the pharmaceutical compositions obtained selon la revendication 7 en vue de la réalisation d'un according to claim 7 for the production of a médicament hypnotique.  hypnotic drug.
FR8716993A 1987-12-07 1987-12-07 NEW PHARMACEUTICAL COMPOSITIONS WITH HYPNOTIC ACTION BASED ON CHLORAL HYDRATE Expired - Fee Related FR2624012B1 (en)

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0574221A1 (en) * 1992-06-08 1993-12-15 Therapicon Srl Pharmaceutical stable formulations of nicorandil
EP0706381A1 (en) * 1993-06-18 1996-04-17 Smithkline Beecham Corporation Soft-shelled gelatin encapsulated particles
EP0815855A1 (en) * 1996-06-28 1998-01-07 McNEIL-PPC, INC. Multiphase soft gelatin dosage form
EP0815864A1 (en) * 1996-06-28 1998-01-07 McNEIL-PPC, INC. Semi-solid composition containing an antiflatulent agent
US6596309B2 (en) * 1999-03-12 2003-07-22 Basf Aktiengesellschaft Stable pharmaceutical dosage form for paroxetin anhydrate
US10064828B1 (en) 2005-12-23 2018-09-04 Intellipharmaceutics Corp. Pulsed extended-pulsed and extended-pulsed pulsed drug delivery systems
US10624858B2 (en) 2004-08-23 2020-04-21 Intellipharmaceutics Corp Controlled release composition using transition coating, and method of preparing same
US10632205B2 (en) 2006-05-12 2020-04-28 Intellipharmaceutics Corp Pharmaceutical composition having reduced abuse potential
CN113662916A (en) * 2021-08-20 2021-11-19 北京弘生医药科技有限公司 Sedative for children and preparation method thereof

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8802139B2 (en) 2003-06-26 2014-08-12 Intellipharmaceutics Corp. Proton pump-inhibitor-containing capsules which comprise subunits differently structured for a delayed release of the active ingredient
US8394409B2 (en) 2004-07-01 2013-03-12 Intellipharmaceutics Corp. Controlled extended drug release technology
CN101453993A (en) 2006-04-03 2009-06-10 伊萨·奥迪迪 Controlled release delivery device comprising an organosol coat

Citations (5)

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Publication number Priority date Publication date Assignee Title
US2585903A (en) * 1950-06-16 1952-02-19 Fellows Medical Mfg Company In Gelatin capsules containing chloral hydrate
GB709283A (en) * 1951-07-02 1954-05-19 Fellows Medical Mfg Company In Gelatine capsules containing chloral hydrate
GB930421A (en) * 1958-12-22 1963-07-03 Upjohn Co Encapsulation of particles by liquid-liquid phase separation
US3126321A (en) * 1964-03-24 Table vii
GB1421144A (en) * 1971-12-29 1976-01-14 Squibb & Sons Inc One piece gelatin capsules containing chloral hydrate

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3126321A (en) * 1964-03-24 Table vii
US2585903A (en) * 1950-06-16 1952-02-19 Fellows Medical Mfg Company In Gelatin capsules containing chloral hydrate
GB709283A (en) * 1951-07-02 1954-05-19 Fellows Medical Mfg Company In Gelatine capsules containing chloral hydrate
GB930421A (en) * 1958-12-22 1963-07-03 Upjohn Co Encapsulation of particles by liquid-liquid phase separation
GB1421144A (en) * 1971-12-29 1976-01-14 Squibb & Sons Inc One piece gelatin capsules containing chloral hydrate

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ROTE LISTE, 1987, no. 48086: "Chloraldurat 500" *

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0574221A1 (en) * 1992-06-08 1993-12-15 Therapicon Srl Pharmaceutical stable formulations of nicorandil
EP0706381A1 (en) * 1993-06-18 1996-04-17 Smithkline Beecham Corporation Soft-shelled gelatin encapsulated particles
EP0706381A4 (en) * 1993-06-18 1997-02-26 Smithkline Beecham Corp Soft-shelled gelatin encapsulated particles
US6024980A (en) * 1996-06-28 2000-02-15 Mcneil-Ppc, Inc. Multiphase soft gelatin dosage form
EP0815864A1 (en) * 1996-06-28 1998-01-07 McNEIL-PPC, INC. Semi-solid composition containing an antiflatulent agent
US5908636A (en) * 1996-06-28 1999-06-01 Mcneil-Ppc, Inc. Fill material for soft gelatin pharmaceutical dosage form containing an antiflatulent
EP0815855A1 (en) * 1996-06-28 1998-01-07 McNEIL-PPC, INC. Multiphase soft gelatin dosage form
US6596309B2 (en) * 1999-03-12 2003-07-22 Basf Aktiengesellschaft Stable pharmaceutical dosage form for paroxetin anhydrate
US10624858B2 (en) 2004-08-23 2020-04-21 Intellipharmaceutics Corp Controlled release composition using transition coating, and method of preparing same
US10064828B1 (en) 2005-12-23 2018-09-04 Intellipharmaceutics Corp. Pulsed extended-pulsed and extended-pulsed pulsed drug delivery systems
US10632205B2 (en) 2006-05-12 2020-04-28 Intellipharmaceutics Corp Pharmaceutical composition having reduced abuse potential
US10960077B2 (en) 2006-05-12 2021-03-30 Intellipharmaceutics Corp. Abuse and alcohol resistant drug composition
CN113662916A (en) * 2021-08-20 2021-11-19 北京弘生医药科技有限公司 Sedative for children and preparation method thereof

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