CH666814A5 - WATER-SOLUBLE PHARMACEUTICAL COMPOSITION CONTAINING N-ACETYL-CISTEIN. - Google Patents

WATER-SOLUBLE PHARMACEUTICAL COMPOSITION CONTAINING N-ACETYL-CISTEIN. Download PDF

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Publication number
CH666814A5
CH666814A5 CH2974/86A CH297486A CH666814A5 CH 666814 A5 CH666814 A5 CH 666814A5 CH 2974/86 A CH2974/86 A CH 2974/86A CH 297486 A CH297486 A CH 297486A CH 666814 A5 CH666814 A5 CH 666814A5
Authority
CH
Switzerland
Prior art keywords
weight
aspartame
nac
sorbitol
acetyl
Prior art date
Application number
CH2974/86A
Other languages
Italian (it)
Inventor
Annibale Gazzaniga
Valter Gianesello
Federico Stroppolo
Original Assignee
Inpharzam Int Sa
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 Inpharzam Int Sa filed Critical Inpharzam Int Sa
Priority to CH2974/86A priority Critical patent/CH666814A5/en
Priority to DE19873723734 priority patent/DE3723734A1/en
Priority to FR878710367A priority patent/FR2601875B1/en
Priority to SE8702941A priority patent/SE500493C2/en
Priority to NL8701744A priority patent/NL194154C/en
Priority to BE8700817A priority patent/BE1000168A3/en
Priority to IT21410/87A priority patent/IT1222103B/en
Priority to GB8717581A priority patent/GB2192789B/en
Publication of CH666814A5 publication Critical patent/CH666814A5/en

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Classifications

    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group

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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)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Description

DESCRIZIONE DESCRIPTION

La N-acetil-cisteina (d'ora in avanti indicata come NAC) è un farmaco che possiede diverse favorevoli proprietà, una di queste è l'attività mucolitica. N-acetyl-cysteine (hereafter referred to as NAC) is a drug that has several favorable properties, one of which is mucolytic activity.

Per l'impiego pratico come mucolitoco la NAC può essere assunta oralmente sotto forma di soluzione acquosa ottenuta per dissolvimento di un granulato o di una compressa afferve-scente. For practical use as a mucolytic, NAC can be taken orally in the form of an aqueous solution obtained by dissolving a granulate or an affervescent tablet.

Le proprietà organolettiche del farmaco possono tuttavia risultare soggettivamente sgradevoli. È quindi necessario attenuare il gusto tipico della NAC in caso di assunzione orale. The organoleptic properties of the drug can however be subjectively unpleasant. It is therefore necessary to attenuate the typical taste of NAC in case of oral intake.

Nelle forme farmaceutiche attualmente presenti in commercio ciò viene realizzato mediante l'aggiunta di saccarosio. In the pharmaceutical forms currently on the market this is accomplished by adding sucrose.

L'impiego di saccarosio, tuttavia, può presentare inconvenienti soprattutto per le persone che soffrono di diabete. The use of sucrose, however, can present drawbacks especially for people suffering from diabetes.

Il saccarosio è inoltre uno zucchero cariogeno. Sucrose is also a cariogenic sugar.

Da ciò la necessità di poter disporre, in alternativa alle forme farmaceutiche già esistenti, di nuove preparazioni farmaceutiche della NAC per uso orale indicate per i soggetti ai quali il 65 saccarosio può essere nocivo. NAC 10 kg Hence the need to have, as an alternative to the already existing pharmaceutical forms, new pharmaceutical preparations of NAC for oral use indicated for subjects to whom 65 sucrose can be harmful. NAC 10 kg

La sostituzione del saccarosio con un dolcificante artificiale Aspartame 2,5 kg o con un edulcorante non cariogeno in una forma farmaceutica Sorbitolo 77,42 kg Substitution of sucrose with an artificial sweetener Aspartame 2.5 kg or with a non-cariogenic sweetener in a pharmaceutical form Sorbitol 77.42 kg

I granulati secondo la presente invenzione risultano prontamente solubili in acqua fornendo una soluzione acquosa di NAC di gradevole palatabilità. The granulates according to the present invention are readily soluble in water by providing an aqueous NAC solution of pleasant palatability.

Con lo scopo di illustrare la presente invenzione, senza tuttavia limitarla, vengono ora forniti i seguenti esempi. With the aim of illustrating the present invention, without however limiting it, the following examples are now provided.

Esempio 1 Un granulato composto da Example 1 A granulate composed of

3 3

666 814 666 814

Aroma arancio 10 kg Esempio 2 Orange flavor 10 kg Example 2

Colorante El 10 0,08 kg In maniera analoga a quanto descritto nell'esempio 1, ma viene preparato secondo la seguente procedura. partendo da El 10 dye 0.08 kg In a manner similar to that described in Example 1, but is prepared according to the following procedure. starting from

Le polveri, tranne il colorante, vengono setacciate su rete NAC 20 kg con 1,07 mm luce netta e miscelate per 10'. La miscela viene s Aspartame 2,5 kg poi granulata in un granulatore a letto fluido con una soluzione Sorbitolo 67,42 kg acquosa del colorante. Aroma arancio 10 kg The powders, except the dye, are sieved on a 20 kg NAC net with 1.07 mm net light and mixed for 10 '. The mixture is s aspartame 2.5 kg then granulated in a fluidized bed granulator with a sorbitol 67.42 kg aqueous solution of the dye. Orange flavor 10 kg

Il granulato è quindi ripartito in bustine di accoppiata carta- ß-carotene 0,08 kg alluminio-politene alla dose di 1 g per bustina (dose di NAC per vengono preparate bustine contenenti 1 g di composizione (con- The granulate is then divided into sachets of laminated paper-ß-carotene 0.08 kg aluminum-polythene at a dose of 1 g per sachet (dose of NAC for sachets containing 1 g of composition are prepared (con-

bustina = 100 mg). io tenuto in NAC = 200 mg). sachet = 100 mg). I kept in NAC = 200 mg).

v v

Claims (7)

666 814 666 814 2 2 RIVENDICAZIONI contenente NAC è un problema che a prima vista può sembrare CLAIMS containing NAC is a problem that at first glance may seem 1. Una composizione farmaceutica contenente N-acetil-ci- di facile soluzione. 1. A pharmaceutical composition containing N-acetyl-ci of easy solution. steina sotto forma di granulato idrosolubile e costituita da: In realtà i problemi sono molteplici e di difficile soluzione. steina in the form of a water-soluble granulate and consisting of: In reality the problems are manifold and difficult to solve. N-acetil-cisteina 10-20% in peso N-acetyl-cysteine 10-20% by weight Ad esempio è necessario che tra la NAC ed il dofcificante vi sia compatibilità chimica, che il dolcificante o l'edulcorante sia- For example, it is necessary that there is chemical compatibility between the NAC and the sweetener, that the sweetener or sweetener is- Aspartame 2- 3% in peso . ... ■ , ^ ce- , . Aspartame 2- 3% by weight. ... ■, ^ ce-,. „ ,. , „ 0_m . no in grado di copnre od attenuare efficacemente il sapore tipi- ",. , „0_m. can not effectively cover or attenuate the typical flavor Sorbitolo 67-87% m peso ..... , , Sorbitol 67-87% m weight .....,, Aroma 10% in peso co della NAC, che il gusto risultante sia comunque gradevole, Aroma 10% by weight with NAC, that the resulting taste is still pleasant, j che il dolcificante o I edulcorante siano adatti alla preparazione il totale essendo il 100%. , „ . . , , j that the sweetener or sweetener are suitable for the preparation, the total being 100%. , ". . ,, » TT . . - .. , . . ,. della forma farmaceutica desiderata e siano compatibili con le »TT. . - ..,. . ,. of the desired pharmaceutical form and are compatible with 2. Una composizione farmaceutica secondo la nvendicazio- . . . , 2. A pharmaceutical composition according to the claim. . . , io lavorazioni ad essa connesse. I work related to it. Abbiamo ora trovato, e forma oggetto della presente invenne 1 contenente anche un colorante per uso farmaceutico. We have now found and forms the subject of the present invention 1 also containing a dye for pharmaceutical use. 3. Una composizione farmaceutica secondo la rivendicazio- . . .. ^ ^ 3. A pharmaceutical composition according to claim. . .. ^ ^ ne 1 o 2 costituita da- zione, una preparazione farmaceutica contenente NAC sotto forma di granulato idrosolubile costituita da (percentuali in N-acetil-cisteina 10 % in peso peso): in 1 or 2 constituted by action, a pharmaceutical preparation containing NAC in the form of a water-soluble granulate consisting of (percentages in N-acetyl-cysteine 10% by weight weight): Aspartame 2,5% in peso ,s NAC 10.20% Aspartame 2.5% by weight, s NAC 10.20% S°rbltol° m peso Aspartame 2- 3% S ° rbltol ° m weight Aspartame 2- 3% /\ TI 1 II7a IM MA/I A / \ TI 1 II7a IM MA / I A Aroma 20 % in peso Aroma 20% by weight 4. Una composizione farmaceutica secondo la rivendicazione 1 o 2 costituita da: A pharmaceutical composition according to claim 1 or 2 consisting of: Sorbitolo 67-78% Sorbitol 67-78% Aroma 10% Aroma 10% il totale essendo il 100%. the total being 100%. 20 20 N-acetil-cisteina 20 % in peso Per questioni di accettabilità da parte del consumatore del N-acetyl-cysteine 20% by weight For reasons of acceptability by the consumer of the Aspartame 2,5% in peso farmaco, l'impiego di un aroma può richiedere la presenza di Aspartame 2.5% by weight drug, the use of an aroma may require the presence of Sorbitolo 67,5% in peso un colorante che viene normalmente associato ad un determina- Sorbitol 67.5% by weight a dye that is normally associated with a specific Aroma 10 % in peso to gusto. Ad esempio l'impiego di aroma di menta può richie- Aroma 10% by weight to taste. For example, the use of mint flavoring may require 5. Una composizione farmaceutica secondo la rivendicazio- dere l'aggiunta di un colorante che impartisce un colore verde ne 1 o 2 costituita da: alla soluzione. 5. A pharmaceutical composition according to claim claiming the addition of a dye which imparts a green color of 1 or 2 consisting of: to the solution. In tali casi, nella compositione può essere utile un quantita- In such cases, a quantity may be useful in the composition N-acetil-cisteina 10 % in peso Aspartame 2,5 % in peso N-acetyl-cysteine 10% by weight Aspartame 2.5% by weight Sorbitolo 77,42% in peso Sorbitol 77.42% by weight Aroma 10 % in peso 30 . .. , .. , ^ c Aroma 10% by weight 30. .., .., ^ c „ , . .OIM . zione viene eseguita secondo normali procedure di tecnica far- ",. .OIM. tion is performed according to normal technical procedures Colorante 0,08% in peso tivo di colorante per uso farmaceutico, ad esempio in quantità comprese tra 0,5 e 1% in peso. Dye 0.08% by weight of dye for pharmaceutical use, for example in quantities ranging from 0.5 to 1% by weight. La preparazione del granulato oggetto della presente inven- The preparation of the granulate object of the present invention 6. Una composizione farmaceutica secondo la rivendicazione 1 o 2 costituita da: A pharmaceutical composition according to claim 1 or 2 consisting of: maceutica. maceutica. Il granulato può essere poi ripartito in idonee bustine contenenti, ad esempio 1, 1,5 o 2 grammi di composizione. N-acetil-cisteina 20 % in peso Facendo riferimento alla dose di 1 g, esempi rappresentativi The granulate can then be divided into suitable sachets containing, for example 1, 1.5 or 2 grams of composition. N-acetyl-cysteine 20% by weight Referring to the 1 g dose, representative examples Aspartame 2,5 % in peso 35 di granulati secondo l'invenzione sono i seguenti: Aspartame 2.5% by weight 35 of granulates according to the invention are the following: Sorbitolo 67,42% in peso Sorbitol 67.42% by weight Aroma 10 % in peso Aroma 10% by weight Colorante 0,08% in peso Dye 0.08% by weight 7. Una composizione farmaceutica secondo la rivendicazione precedente contenente per singola dose 100 o 200 mg di N-acetil-cisteina. A pharmaceutical composition according to the preceding claim containing per single dose 100 or 200 mg of N-acetyl-cysteine. — NAC - NAC 100 100 mg mg Aspartame Aspartame 25 25 mg mg Sorbitolo Sorbitol 775 775 mg mg Aroma limone Lemon flavor 100 100 mg mg — NAC - NAC 100 100 mg mg Aspartame Aspartame 25 25 mg mg Sorbitolo Sorbitol 774,2 774.2 mg mg Aroma menta Mint flavor 100 100 mg mg Colorante verde Green dye 0,8 0.8 mg mg — NAC - NAC 200 200 mg mg Aspartame Aspartame 25 25 mg mg Sorbitolo Sorbitol 675 675 mg mg Aroma limone Lemon flavor 100 100 mg mg — NAC - NAC 200 200 mg mg Aspartame Aspartame 25 25 mg mg Sorbitolo Sorbitol 674,2 674.2 mg mg Aroma arancio Orange aroma 100 100 mg mg Colorante arancio (o ß-carotene) Orange dye (or ß-carotene) 0,8 0.8 mg mg
CH2974/86A 1986-07-24 1986-07-24 WATER-SOLUBLE PHARMACEUTICAL COMPOSITION CONTAINING N-ACETYL-CISTEIN. CH666814A5 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
CH2974/86A CH666814A5 (en) 1986-07-24 1986-07-24 WATER-SOLUBLE PHARMACEUTICAL COMPOSITION CONTAINING N-ACETYL-CISTEIN.
DE19873723734 DE3723734A1 (en) 1986-07-24 1987-07-17 PHARMACEUTICAL, N-ACETYLCYSTONE CONTAINING WATER-SOLUBLE COMPOSITION
FR878710367A FR2601875B1 (en) 1986-07-24 1987-07-22 WATER-SOLUBLE PHARMACEUTICAL COMPOSITION CONTAINING N-ACETYL-CYSTEINE AND SORBITOL
SE8702941A SE500493C2 (en) 1986-07-24 1987-07-23 Pharmaceutical, water-soluble composition containing N-acetyl-cysteine, aspartame and sorbitol
NL8701744A NL194154C (en) 1986-07-24 1987-07-23 Pharmaceutical water-soluble preparation containing N-acetylcysteine and aspartame.
BE8700817A BE1000168A3 (en) 1986-07-24 1987-07-23 Pharmaceutical composition containing soluble n-acetyl-cysteine and sorbitol.
IT21410/87A IT1222103B (en) 1986-07-24 1987-07-23 WATER SOLUBLE PHARMACEUTICAL COMPOSITION CONTAINING N ACETYLCISTEIN
GB8717581A GB2192789B (en) 1986-07-24 1987-07-24 N-acetyl cysteine granular compositions.

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CH2974/86A CH666814A5 (en) 1986-07-24 1986-07-24 WATER-SOLUBLE PHARMACEUTICAL COMPOSITION CONTAINING N-ACETYL-CISTEIN.

Publications (1)

Publication Number Publication Date
CH666814A5 true CH666814A5 (en) 1988-08-31

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ID=4245819

Family Applications (1)

Application Number Title Priority Date Filing Date
CH2974/86A CH666814A5 (en) 1986-07-24 1986-07-24 WATER-SOLUBLE PHARMACEUTICAL COMPOSITION CONTAINING N-ACETYL-CISTEIN.

Country Status (8)

Country Link
BE (1) BE1000168A3 (en)
CH (1) CH666814A5 (en)
DE (1) DE3723734A1 (en)
FR (1) FR2601875B1 (en)
GB (1) GB2192789B (en)
IT (1) IT1222103B (en)
NL (1) NL194154C (en)
SE (1) SE500493C2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113559078A (en) * 2021-07-02 2021-10-29 安徽省先锋制药有限公司 Preparation method of acetylcysteine effervescent tablets

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CH674940A5 (en) * 1988-05-05 1990-08-15 Ibsa Inst Biochimique Sa
DE3909049A1 (en) * 1989-03-18 1990-09-20 Arthur Boskamp PREPARATION AND THEIR USE
US5296500A (en) * 1991-08-30 1994-03-22 The Procter & Gamble Company Use of N-acetyl-cysteine and derivatives for regulating skin wrinkles and/or skin atrophy
IT1256616B (en) * 1992-12-02 1995-12-12 Zambon Spa SYRUP CONTAINING N-ACETYL-CISTEIN
GB9226729D0 (en) * 1992-12-22 1993-02-17 Wellcome Found Therapeutic combination
DE4406261C2 (en) * 1993-08-31 1996-07-04 Deutsches Krebsforsch Use of thiol compounds to reduce body fat
DE4329857C2 (en) * 1993-09-03 1995-08-24 Deutsches Krebsforsch Connection to strengthen the immune system and immune reactions
BE1007926A3 (en) * 1994-01-31 1995-11-21 Zambon Int Pharma Pharmaceutical composition containing n-acetyl-cysteine.
US5451405A (en) * 1994-04-25 1995-09-19 Chesebrough-Pond's Usa Co. Skin treatment composition
WO2000018392A1 (en) * 1998-09-25 2000-04-06 Glycox Corporation Limited Fructosamine oxidase: antagonists and inhibitors
JP2002525106A (en) 1998-09-25 2002-08-13 グリコックス コーポレイション リミティド Fructosamine oxidase assay: methods and materials
EP1293251A1 (en) * 2001-09-14 2003-03-19 Holland Sweetener Company V.o.F. Process for the production of alpha-L-aspartyl-l-phenylalanine methyl ester powder
ES2386782T3 (en) 2002-03-08 2012-08-30 Philera New Zealand Limited Prevention and / or treatment of cardiovascular disease and / or associated heart failure
EP1539129A4 (en) 2002-08-20 2006-03-08 Protemix Corp Ltd Dosage forms and related therapies
DK1778618T3 (en) 2004-07-19 2014-03-10 Philera New Zealand Ltd Synthesis of triethylenetetramines
GR1007236B (en) * 2009-12-07 2011-04-08 Uni-Pharma Κλεων Τσετης Φαρμακευτικα Εργαστηρια Αβεε Με Δ.Τ. Uni-Pharma Abee, New pharmaceutical composition of n-acetylcysteine granules and production method thereof
IT1399492B1 (en) * 2010-04-13 2013-04-19 Alpex Pharma Sa EFFERVESCENT PHARMACEUTICAL COMPOSITIONS CONTAINING N-ACETYLCISTEIN.
CN103142505B (en) * 2013-03-29 2015-03-11 山东罗欣药业集团股份有限公司 Acetylcysteine composition granules and preparation method thereof
EP3505153B1 (en) 2017-12-31 2021-03-24 Abdi Ibrahim Ilac Sanayi ve Ticaret A.S. A pharmaceutical composition comprising acetylcysteine which is free of methylparaben and propylparaben

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IT1170268B (en) * 1983-12-21 1987-06-03 Zambon Spa USE OF ACETYLCISTEIN TO REDUCE THE INCREASE IN THE PROLIEFERATION OF THE BASAL CELLS OF THE RESPIRATORY THRACHEO-BRONCHIAL EPITHELIUM INDUCED BY TOBACCO SMOKE IN MAMMALS
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113559078A (en) * 2021-07-02 2021-10-29 安徽省先锋制药有限公司 Preparation method of acetylcysteine effervescent tablets

Also Published As

Publication number Publication date
NL194154B (en) 2001-04-02
SE8702941D0 (en) 1987-07-23
SE500493C2 (en) 1994-07-04
NL194154C (en) 2001-08-03
FR2601875A1 (en) 1988-01-29
IT1222103B (en) 1990-08-31
GB8717581D0 (en) 1987-09-03
DE3723734C2 (en) 1992-05-21
NL8701744A (en) 1988-02-16
GB2192789A (en) 1988-01-27
DE3723734A1 (en) 1988-02-04
IT8721410A0 (en) 1987-07-23
GB2192789B (en) 1990-01-31
SE8702941L (en) 1988-01-25
BE1000168A3 (en) 1988-07-05
FR2601875B1 (en) 1992-02-21

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