SE520834C2 - Syrup containing N-acetylcysteine - Google Patents
Syrup containing N-acetylcysteineInfo
- Publication number
- SE520834C2 SE520834C2 SE9502001A SE9502001A SE520834C2 SE 520834 C2 SE520834 C2 SE 520834C2 SE 9502001 A SE9502001 A SE 9502001A SE 9502001 A SE9502001 A SE 9502001A SE 520834 C2 SE520834 C2 SE 520834C2
- Authority
- SE
- Sweden
- Prior art keywords
- sodium
- solution
- syrup
- nac
- water
- Prior art date
Links
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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/12—Mucolytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/14—Antitussive agents
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- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Jellies, Jams, And Syrups (AREA)
- Food Preservation Except Freezing, Refrigeration, And Drying (AREA)
Abstract
Description
' 30 35 e -fi bl» :-; i ;f}¿ï iszo 854 i-nw-v 2 Efter beredning måste ex tempore-sirapen användas inom tre veckor. '30 35 e -fi bl »: -; i; f} ¿ï iszo 854 i-nw-v 2 After reconstitution, the ex tempore syrup must be used within three weeks.
Vi har nu överraskande funnit att det är möjligt att framställa en NAC-sirap som är stabil med tiden och som har en angenäm smak utan användning av sockerarter.We have now surprisingly found that it is possible to produce a NAC syrup which is stable over time and which has a pleasant taste without the use of sugars.
Ett föremål för föreliggande uppfinning är därför en komposition i form av en sirap innehållande (per 100 ml). 2-4,2 g/100 ml 0,02-0,3 g/100 ml - N-acetylcystein - ett sötningsmedel - ett förtjockningsmedel som är valt bland natriumkarboximetylcellulosa och hydroxipropylmetylcellulosa eller 0,1-4 blandningar därav g/100 ml och eventuellt 0,1-0,4 g/100 ml 0,05-0,5 g/100 ml - ett smakämne - ett konserveringsmedel och dessutom - vatten till en volym av 100 ml pH-värdet justeras till att ligga inom inter- vallet 5-8.An object of the present invention is therefore a composition in the form of a syrup containing (per 100 ml). 2-4.2 g / 100 ml 0.02-0.3 g / 100 ml - N-acetylcysteine - a sweetener - a thickener selected from sodium carboxymethylcellulose and hydroxypropylmethylcellulose or 0.1-4 mixtures thereof g / 100ml and optionally 0.1-0.4 g / 100 ml 0.05-0.5 g / 100 ml - a flavoring agent - a preservative and in addition - water to a volume of 100 ml The pH value is adjusted to be within the range 5-8.
Ovannämnda lösning har visat sig vara stabil i en tillsluten flaska under inert gas under minst 2 àr vid om- givande betingelser. När flaskan öppnas, visar sig lös- ningen ha en angenäm smak och vara fri fràn dàliga lukter, NAC förblir i sin initiala titer och den öppna sirapen visar sig vara stabil under minst 5 veckor.The above solution has been found to be stable in a closed bottle under inert gas for at least 2 years under ambient conditions. When the bottle is opened, the solution turns out to have a pleasant taste and be free from bad smells, NAC remains in its initial titer and the open syrup turns out to be stable for at least 5 weeks.
Som sötningsmedel avses ett ämne som ger lösningen en söt smak, men som inte innehåller sockerarter. Specifika exempel pá sötningsmedel är sackarin, natriumsackarin och cyklamater eller blandningar därav.Sweetener refers to a substance which gives the solution a sweet taste, but which does not contain sugars. Specific examples of sweeteners are saccharin, sodium saccharin and cyclamates or mixtures thereof.
Mängden sötningsmedel är den som är minimal för att ge lösningen en angenäm smak.The amount of sweetener is the one that is minimal to give the solution a pleasant taste.
Förtjockningsmedlet är valt bland natriumkarboxi- metylcellulosa, metylcellulosa och hydroxipropylmetyl- cellulosa eller blandningar därav. Dessa ämnen har 10 15 20 25' 30 35 (520 854 § 3 överraskande nog visat sig vara kompatibla med NAC och kan ge lösningen en tjocklek som är lämplig för den vanliga palatabiliteten för sirap.The thickener is selected from sodium carboxymethylcellulose, methylcellulose and hydroxypropylmethylcellulose or mixtures thereof. These substances have surprisingly been found to be compatible with NAC (520 854 § 3) and can give the solution a thickness which is suitable for the usual palatability of syrup.
Till dessa tre baskomponenter (NAC, sötningsmedel och förtjockningsmedel) kan vatten tillsättas upp till den ut- valda volymen genom eventuell korrigering av det resulte- rande pH-värdet så att det upprätthålls inom intervallet 5-8. Företrädesvis är pH-värdet från 6,5 till 7. Sirapen kan också, dock ej nödvändigtvis, innehålla ett smakämne i syfte att förbättra palatabiliteten, särskilt för pediat- risk användning.To these three basic components (NAC, sweetener and thickener) water can be added up to the selected volume by possibly correcting the resulting pH value so that it is maintained within the range 5-8. Preferably the pH value is from 6.5 to 7. The syrup may also, but not necessarily, contain a flavoring in order to improve palatability, especially for pediatric use.
Eftersom sirapen i allmänhet tillverkas i frånvaro av asepsis, kräver farmakopén obligatorisk närvaro av ett konserveringsmedel. Konserveringsmedlet krävs dessutom för garanti av mikrobiologisk kvalitet under användningstiden för patienten.Because the syrup is generally made in the absence of asepsis, the pharmacopoeia requires the mandatory presence of a preservative. The preservative is also required to guarantee microbiological quality during the patient's use time.
I detta fall används företrädesvis konserveringsmedel som är valda bland natriumbensoat, metyl-4-hydroxibensoat, propyl-4-hydroxibensoat och blandningar därav.In this case, preservatives selected from sodium benzoate, methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate and mixtures thereof are preferably used.
Med den dubbla funktionen av att vara konserverings- medel och metallkelateringsmedel kan även natrium-EDTA an- vändas utöver eller som delvis ersättning för ovannämnda konserveringsmedel.With the dual function of being a preservative and metal chelating agent, sodium EDTA can also be used in addition to or as a partial substitute for the above-mentioned preservatives.
Beredningen av sirapen enligt föreliggande uppfinning utförs i inert gas genom helt enkelt upplösning av ämnena i den förutbestämda mängden vatten.The preparation of the syrup of the present invention is carried out in inert gas by simply dissolving the substances in the predetermined amount of water.
Den resulterande lösningen uppdelas i multidosflaskor eller i enkeldosbehállare.The resulting solution is divided into multidose vials or single-dose containers.
Förpackningen av multidosflaskor kan samtidigt möj- liggöra tillsättning av en uppmätt mängd för korrekt dose- ring av enkeldoser för vuxna människor (t ex 10 ml) eller för barn (t ex 5 ml).The packaging of multi-dose bottles can at the same time make it possible to add a measured amount for the correct dosing of single doses for adults (eg 10 ml) or for children (eg 5 ml).
I syfte att bättre belysa föreliggande uppfinning anges följande exempel.In order to better illustrate the present invention, the following examples are set forth.
Exempel 1 10 l av en sirap innehållande (per 100 ml): NAC 2,1 g sackarin 0,04 g 10 15 20 25' 30 35 »fwvw i 520 834 4 natriumkarboximetylcellulosa 0,2 g natriumbensoat 0,15 g natriumedetat 0,1 g hallonsmak 0,25 g och vatten upp till 100 ml, framställdes genom enkel upplösning av ämnena i renat och avluftat vatten i kväveatmosfär.Example 1 10 l of a syrup containing (per 100 ml): NAC 2.1 g of saccharin 0.04 g of sodium carboxymethylcellulose 0.2 g of sodium benzoate 0.15 g of sodium edetate 0, 1 g of raspberry flavor 0.25 g and water up to 100 ml, were prepared by simply dissolving the substances in purified and deaerated water in a nitrogen atmosphere.
Den resulterande lösningens pH-värde korrigerades till det korrekta värdet 6,5 genom tillsättning av natriumhydroxid.The pH of the resulting solution was corrected to the correct 6.5 by adding sodium hydroxide.
Lösningen uppdelades i en mängd av 150 ml/flaska.The solution was aliquoted at 150 ml / bottle.
Flaskorna förvarandes under 2 år vid rumstemperatur.The bottles were stored for 2 years at room temperature.
Efter denna period visade sig NAC-titern vara mer än 95% av den ursprungliga.After this period, the NAC titer was found to be more than 95% of the original.
En sàdan titer visade sig vara högre än 90% av den ursprungliga även 5 veckor efter öpnnandet av flaskan.Such a titer was found to be higher than 90% of the original even 5 weeks after opening the bottle.
Sirapen visade sig efter 2 års förvaring ha en ange- näm smak och lukt samt en tillfredsställande allmän palatabilitet.After 2 years of storage, the syrup was found to have a pleasant taste and smell as well as a satisfactory general palatability.
Exempel 2 10 1 av en sirap med följande sammansättning (per 100 ml): NAC 2,1 g natriumsackarin 0,04 g hydroxipropylmetylcellulosa 0,2 g metyl-4-hydroxibensoat 0,1 g natriumedetat 0,1 g aprikossmak 0,1 g och vatten upp till 100 ml, bereddes genom dispergering av hydroxipropylmetylcellulosa i en del kokande vatten som kylts till rumstemperatur. Ef- ter hydratisering av hydroxipropylmetylcellulosa hälldes den i en lösning som erhållits genom upplösning av samt- liga kvarvarande ämnen i renat och avluftat vatten i kväveatmosfär.Example 2 1 of a syrup having the following composition (per 100 ml): NAC 2.1 g sodium saccharin 0.04 g hydroxypropyl methylcellulose 0.2 g methyl 4-hydroxybenzoate 0.1 g sodium edetate 0.1 g apricot flavor 0.1 g and water up to 100 ml, were prepared by dispersing hydroxypropyl methylcellulose in a portion of boiling water cooled to room temperature. After hydration of hydroxypropyl methylcellulose, it was poured into a solution obtained by dissolving all the remaining substances in purified and deaerated water in a nitrogen atmosphere.
Lösningens pH-värde korrigerades till 6,5 med natriumhydroxid. 10 15 20 25 30 35 520 854 ;:É §“É 5 Lösningen uppdelades i enkeldospàsar av 10 ml vardera innehållande ca 200 mg NAC.The pH of the solution was corrected to 6.5 with sodium hydroxide. 10 15 20 25 30 35 520 854;: É § “É 5 The solution was divided into single doses of 10 ml each containing about 200 mg of NAC.
Exempel 3 10 1 av en sirap med följande sammansättning (per 100 ml): NAC 2,1 g natriumsackarin 0,04 g hydroxipropylmetylcellulosa 0,2 g natriumedetat 0,1 g aprikossmak 0,1 g och vatten upp till 100 ml, bereddes genom dispergering av hydroxipropylmetylcellulosa i en del kokande vatten som kyldes till rumstemperatur. hälldes samt- Efter hydratisering av hydroxipropylmetylcellulosa den i en lösning som erhållits genom upplösning av liga kvarvarande ämnen i renat och avluftat vatten i kväveatmosfär.Example 3 1 of a syrup having the following composition (per 100 ml): NAC 2.1 g of sodium saccharin 0.04 g of hydroxypropyl methylcellulose 0.2 g of sodium edetate 0.1 g of apricot flavor 0.1 g and water up to 100 ml, were prepared by dispersing hydroxypropyl methylcellulose in a portion of boiling water which was cooled to room temperature. After hydration of hydroxypropyl methylcellulose, it was poured into a solution obtained by dissolving the remaining residues in purified and deaerated water in a nitrogen atmosphere.
Lösningens pH-värde korrigerades till 6,5 med natriumhydroxid.The pH of the solution was corrected to 6.5 with sodium hydroxide.
Lösningen uppdelades i enkeldosglasflaskor av 10 ml med en gummipropp och innehöll vardera ca 200 mg NAC.The solution was divided into 10 ml single dose glass bottles with a rubber stopper and each contained about 200 mg of NAC.
Exempel 4 _ GEnom att följa exempel 1 bereddes 10 l sirap med följande sammansättning (per 100 ml): 'NAC 4,2 g natriumsackarin 0,08 g natriumkarboximetylcellulosa 0,20 g natriumbensoat 0,15 g natriumedetat 0,10 g hallonsmak 0,4 g och vatten upp till 100 ml.Example 4 Following Example 1, 10 liters of syrup were prepared having the following composition (per 100 ml): NAC 4.2 g sodium saccharin 0.08 g sodium carboxymethylcellulose 0.20 g sodium benzoate 0.15 g sodium edetate 0.10 g raspberry flavor 0 4 g and water up to 100 ml.
Lösningens pH-värde korrigerades till 6,5 med natriumhydroxid.The pH of the solution was corrected to 6.5 with sodium hydroxide.
Lösningen uppdelades i flaskor med en mängd av 150 ml vardera. 10 15 20 25“ 30 35 pg; u s ~«»o ..,.«..- 520 834 Exempel 5 Genom att följa exempel 2 bereddes 10 följande sammansättning (per 100 ml): NAC 2,10 sackarin 0,04 hydroxipropylmetylcellulosa 0,40 metyl-4-hydroxibensoat 0,10 banansmak 0,4 och vatten upp till 100 ml.The solution was divided into bottles of 150 ml each. 10 15 20 25 “30 35 pg; 520 834 Example 5 Following Example 2, the following composition was prepared (per 100 ml): NAC 2.10 saccharin 0.04 hydroxypropyl methylcellulose 0.40 methyl 4-hydroxybenzoate , 10 banana flavor 0.4 and water up to 100 ml.
Lösningens pH-värde korrigerades till hydroxid.The pH of the solution was corrected to hydroxide.
Lösningen uppdelades i flaskor med en vardera. l av sirap med flQlQQlQlQ 7 med natrium- mängd av 450 mlThe solution was divided into bottles of one each. 1 of syrup with fl QlQQlQlQ 7 with a sodium content of 450 ml
Claims (4)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ITMI922758A IT1256616B (en) | 1992-12-02 | 1992-12-02 | SYRUP CONTAINING N-ACETYL-CISTEIN |
PCT/EP1993/003280 WO1994012168A1 (en) | 1992-12-02 | 1993-11-23 | Syrup containing n-acetyl-cysteine |
Publications (3)
Publication Number | Publication Date |
---|---|
SE9502001D0 SE9502001D0 (en) | 1995-06-01 |
SE9502001L SE9502001L (en) | 1995-07-21 |
SE520834C2 true SE520834C2 (en) | 2003-09-02 |
Family
ID=11364395
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
SE9502001A SE520834C2 (en) | 1992-12-02 | 1995-06-01 | Syrup containing N-acetylcysteine |
Country Status (23)
Country | Link |
---|---|
JP (1) | JPH08503703A (en) |
AT (1) | AT407113B (en) |
AU (1) | AU667611B2 (en) |
BE (1) | BE1006799A3 (en) |
CA (1) | CA2150462C (en) |
CH (1) | CH685371A5 (en) |
CZ (1) | CZ282550B6 (en) |
DE (2) | DE4396086B3 (en) |
DK (1) | DK176247B1 (en) |
ES (1) | ES2070806B1 (en) |
FR (1) | FR2698545B1 (en) |
GB (1) | GB2288977B (en) |
HU (2) | HU221484B (en) |
IT (1) | IT1256616B (en) |
LU (1) | LU88618A1 (en) |
MD (1) | MD1714G2 (en) |
NL (1) | NL194957C (en) |
NO (1) | NO314018B1 (en) |
NZ (1) | NZ258544A (en) |
RU (1) | RU2108777C1 (en) |
SE (1) | SE520834C2 (en) |
UA (1) | UA27142C2 (en) |
WO (1) | WO1994012168A1 (en) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ATE210975T1 (en) * | 1994-06-23 | 2002-01-15 | Procter & Gamble | TOPICAL PREPARATIONS CONTAINING N-ACETYL-L-CYSTEIN |
JP4501023B2 (en) * | 2002-11-14 | 2010-07-14 | 小林製薬株式会社 | Composition with reduced bitterness and odor of cysteines |
JP4501024B2 (en) * | 2002-11-14 | 2010-07-14 | 小林製薬株式会社 | Composition with reduced bitterness and odor of cysteines |
US8148356B2 (en) * | 2005-08-24 | 2012-04-03 | Cumberland Pharmaceuticals, Inc. | Acetylcysteine composition and uses therefor |
CN102233139B (en) * | 2010-04-21 | 2012-09-05 | 重庆健能医药开发有限公司 | Acetylcysteine effervescent tablet and preparation method and application thereof |
RU2611411C1 (en) * | 2016-01-11 | 2017-02-21 | Общество с ограниченной ответственностью "Трейдсервис" | Dispersible in water acetylcysteine tablet and method of manufacturing thereof |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB905197A (en) * | 1960-01-01 | 1962-09-05 | Lab Francais Chimiotherapie | Anti-viral compositions comprising 1-phenyl-2-amino-propane-1,3-diol derivatives |
CA1239349A (en) * | 1983-10-10 | 1988-07-19 | Eberhard F. Gottwald | Pharmaceutical composition containing cimetidine |
BE901885A (en) * | 1985-03-06 | 1985-07-01 | Bruschettini Srl | Stable ophthalmic soln. contg. N-acetyl-cysteine - prepd. in nitrogen satd. aq. buffer free of metal ions |
CH666814A5 (en) * | 1986-07-24 | 1988-08-31 | Inpharzam Int Sa | WATER-SOLUBLE PHARMACEUTICAL COMPOSITION CONTAINING N-ACETYL-CISTEIN. |
CH667590A5 (en) * | 1986-07-24 | 1988-10-31 | Inpharzam Int Sa | WATER-SOLUBLE EFFERVESCENT PHARMACEUTICAL COMPOSITION CONTAINING N-ACETYL-CISTEIN. . |
US4861797A (en) * | 1987-10-15 | 1989-08-29 | Oratech Pharmaceutical Development Corporation | Liquid ibuprofen compositions and methods of making them |
CH674940A5 (en) * | 1988-05-05 | 1990-08-15 | Ibsa Inst Biochimique Sa | |
IT1234194B (en) * | 1988-05-31 | 1992-05-06 | Magis Farmaceutici | SYRUP PHARMACEUTICAL COMPOSITIONS CONTAINING PENTITLES AS VEHICULATING AGENTS |
ES2054089T3 (en) * | 1988-11-10 | 1994-08-01 | Ciba Geigy Ag | LIQUID ORAL FORMULATIONS. |
IT1231012B (en) * | 1989-07-27 | 1991-11-08 | Zambon Spa | PHARMACEUTICAL COMPOSITION FOR ORAL USE CONTAINING NAC. |
IT1248998B (en) * | 1990-06-26 | 1995-02-11 | Iscofar Sas | COMPOSITION OF RUBBER TO BE CHEWED FOR THE PREVENTION AND TREATMENT OF DENTAL PLATE |
DK0481294T4 (en) * | 1990-10-19 | 2001-06-18 | Spirig Ag | Solid, fast-soluble drug preparation containing N-acetylcysteine |
-
1992
- 1992-12-02 IT ITMI922758A patent/IT1256616B/en active IP Right Grant
-
1993
- 1993-11-23 DE DE4396086A patent/DE4396086B3/en not_active Expired - Lifetime
- 1993-11-23 DE DE4396086T patent/DE4396086T1/en active Pending
- 1993-11-23 HU HU9501586A patent/HU221484B/en unknown
- 1993-11-23 UA UA95062994A patent/UA27142C2/en unknown
- 1993-11-23 GB GB9509822A patent/GB2288977B/en not_active Expired - Lifetime
- 1993-11-23 CZ CZ951367A patent/CZ282550B6/en not_active IP Right Cessation
- 1993-11-23 AT AT0906093A patent/AT407113B/en not_active IP Right Cessation
- 1993-11-23 JP JP6512747A patent/JPH08503703A/en active Pending
- 1993-11-23 NZ NZ258544A patent/NZ258544A/en not_active IP Right Cessation
- 1993-11-23 CH CH2423/94A patent/CH685371A5/en not_active IP Right Cessation
- 1993-11-23 RU RU95114406A patent/RU2108777C1/en active
- 1993-11-23 AU AU56266/94A patent/AU667611B2/en not_active Expired
- 1993-11-23 NL NL9320052A patent/NL194957C/en not_active IP Right Cessation
- 1993-11-23 ES ES09450021A patent/ES2070806B1/en not_active Expired - Fee Related
- 1993-11-23 WO PCT/EP1993/003280 patent/WO1994012168A1/en active IP Right Grant
- 1993-11-23 MD MD96-0265A patent/MD1714G2/en unknown
- 1993-11-23 CA CA002150462A patent/CA2150462C/en not_active Expired - Lifetime
- 1993-12-01 BE BE9301326A patent/BE1006799A3/en not_active IP Right Cessation
- 1993-12-02 FR FR9314443A patent/FR2698545B1/en not_active Expired - Lifetime
-
1994
- 1994-05-24 LU LU88618A patent/LU88618A1/en unknown
-
1995
- 1995-05-31 DK DK199500614A patent/DK176247B1/en not_active IP Right Cessation
- 1995-06-01 SE SE9502001A patent/SE520834C2/en not_active IP Right Cessation
- 1995-06-01 NO NO19952183A patent/NO314018B1/en not_active IP Right Cessation
- 1995-06-29 HU HU95P/P00579P patent/HU211912A9/en unknown
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Legal Events
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NUG | Patent has lapsed |