Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1995-09-07
1998-01-13
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424489, A61K 916, A61K 946
Patent
active
057076545
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/HU94/00006 filed Mar. 10, 1994.
The invention relates to sugar- and sodium-free effervescent tablets and granules and a process for their preparation.
More specifically, the invention relates to effervescent tablets and granules comprising a shell material, a basic effervescent and disintegrating (further on: sparkling) component, an acidic sparkling component, and a sweetening agent, further macro- and trace elements and optionally vitamins. Furthermore, the invention relates to a process for the preparation of such tablets and granules.
It is known that nowadays one of the most popular pharmaceutical form for introducing medicines, vitamins and mineral substances to the organism is the so-called effervescent tablet (Pharmaceutical Dosage Form: Tablets, Vol. I., 2nd edition, A. Lieberman ed., 1989, Marcel Dekker, Inc.). The development of this form is supported from the viewpoint of pharmaceutical effect, beside commercial reasons, by several factors, e.g. the decrease of stomach irritation, the enhancement of absorption, etc. The solution of such tablets in water results in a carbonated or sparkling beverage containing carbon dioxide.
The spectacular disintegration of effervescent tablets is caused by a mixture consisting of an acid and a base, wherein said mixture when contacting with water nearly wedges the tablet during evolution of carbon dioxide.
The manufacturing and packaging of effervescent tablets requires high care; consequently, in the practice the direct compressing method is preferred to the wet processes.
Most effervescent tablets comprise three main components beside the active agents: a shell and binding agent, an acidic sparkling agent and a basic sparkling agent.
As shell and binding agent sugars (lactose, saccharose, glucose), sorbitol, xylitol or starch, as acidic sparkling agent citric acid, tartaric acid, fumaric acid or adipic acid while as basic sparkling component sodium hydrogen carbonate, sodium carbonate and magnesium carbonate are generally used.
From the other components generally used in effervescent tablets the following preferable agents are mentioned: sweetening agents such as sugars, saccharin, sodium cyclamate and aspartame; flavouring and aroma agents; lubricating agents such as polyethylene glycols, silicone oils, stearates and adipic acid.
The U.S. Pat. No. 4,725,427 describes an effervescent tablet which contains lactose as shell material, citric acid as acidic sparkling agent, a mixture of sodium hydrogen carbonate and potassium hydrogen carbonate as basic sparkling component and aspartame as sweetening agent. Beside water and fat-soluble vitamins this tablet contains inorganic substances as active agents and these substances are rendered more utilizable biologically by using them in chelate form. This composition does not render possible, however, the preparation of sodium-free tablets and this is a considerable disadvantage since it is well-known that the introduction of an excess of sodium into the organism results in several deleterious physiological effects. A further disadvantage of this composition is caused by the presence of citric acid in an amount of 20-45% by mass since the high amount of this acid may result in harmful physiological effects.
The U.S. Pat. No. 4,678,661 describes effervescent tablets containing a mixture of calcium carbonate and potassium carbonate as basic sparkling component. It is a considerable disadvantage of this tablet that the disagreeable soapy flavour of potassium hydrogen carbonate can be tasted in it. Besides, the use of calcium carbonate unfavourably influences the dissolution time.
The U.S. Pat. No. 4,704,269 describes an effervescent tablet comprising potassium hydrogen carbonate as basic sparkling component, malic acid and citric acid as acidic sparkling components, a mixture of sorbitol and maltodextrin as shell and binding agents and calcium saccharate as sweetening agent. This composition is used as antacid and analgesic; its disadvantage is that, owing to the presence of sorbitol, it
REFERENCES:
patent: 5424074 (1995-06-01), Koli et al.
Barkanyi Istvanne
Beres Jozsef
Lex Laszlo
Beres Reszvenytarsasag
Page Thurman K.
Spear James M.
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