Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2000-05-11
2002-06-25
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S488000, C424S484000, C424S486000
Reexamination Certificate
active
06410051
ABSTRACT:
The invention relates to pressed or compressed chloramine-T tablets and a method for the production thereof. Chloramine-T is a known disinfecting and antistaling agent, which is usable in wide ranges of application. It is normally in the pulverulent state, where it is difficult to handle. This is in part due to the fact that the powder easily flies up during handling. It is therefore desirable to have chloramine-T in a compact form, particularly in a tablet form. Tablets containing chloramine-T are already known. These tablets are used for keeping cut flowers fresh, in that they are added to the water for the flowers. However, the tablets have an active ingredient content below 20 wt. %.
For the industrial use of chloramine-T, particularly in the hygiene sector, food production and disinfection, not only are larger chloramine-T quantities necessary, but also higher chloramine-T active ingredient contents are desired, namely for cost reasons, transportation reasons and for avoiding larger quantities of auxiliary agents or adjuvants, which have no effect and are prejudicial during use or can give rise to disposal problems. However, without larger quantities of pressing or compressing agents, it is not possible to press or compress pulverulent chloramine-T with an adequate strength.
The problem of the invention is therefore to provide chloramine-T tablets with a high active ingredient content and correspondingly low quantities of pressing agents and other additives. The tablets are to have an adequate strength for handling, associated with a rapid dissolvability.
The compressed tablets according to the invention contain more than 50 wt. % of chloramine-T as the main constituent, as well as at least one pressing agent and at least one agent aiding rapid dissolving, particularly a disintegrating agent, as secondary constituents. Apart from pressing agents and solubilizers or disintegrating agents, if desired, further secondary constituents may be present, particularly fillers or also other adjuvants or auxiliary agents, such as antifoaming agents. The chloramine-T active ingredient content is preferably at least 80 wt. %, particularly at least 90 wt. %. In special cases it can even be up to 97 wt. %. Such high active ingredient contents are made possible through the combination of pressing agents and solubilizers.
Preferably at least one of the secondary constituents has combined characteristics and serves both as a pressing agent and as a solubilizer. In this way it is possible to keep the content of secondary constituents low and to correspondingly raise the active ingredient content. As pressing agents are in particular suitable magnesium stearate, highly disperse amorphous silica (silicon dioxide), pulverulent polyethylene glycols, sodium carboxymethyl cellulose and/or microcrystalline cellulose.
As agents aiding rapid dissolving, particularly as disintegrating agents, are in particular suitable sodium carboxymethyl starch or sodium-starch-glycolate, prepasted corn starch, sodium carboxymethyl cellulose and/or pulverulent polyethylene glycols. These constituents are more particularly suitable because even in small proportional quantities of 0.25 to less than 5 wt. %, particularly in combination with one another, they evolve their full efficacy. The mixture preferably contains at least approximately 60%, particularly at least approximately 80% of the aforementioned substances.
Chloramine-T ((N-chloro-p-toluenesulphonamido) sodium) has a very broad action spectrum as a disinfectant. It is active against bacteria, viruses, yeasts, fungi and algae, so that there is a very wide application spectrum. Great significance is attached here to the hygiene sector, particularly in clinics, public baths abattoirs, etc. It is a valuable disinfectant in agriculture and in veterinary medicine. It is suitable for conserving water, particularly for keeping fountains clean. According to the invention the tablets have an active ingredient content of chloramine-T of more than 50 wt. %. In fact, higher active ingredient percentages are possible and desired. Thus, as a rule, the active ingredient proportion is at least 70 wt. % or higher. Tablets with a high chloramine-T content have an active ingredient content of 80 or 90 wt. %. The weight proportion of auxiliary substances is correspondingly low and substantially and generally make up the difference to 100%. However, it has been found that a larger number of auxiliary substances, which exercise a mutual, synergistic effect, is more favourable than a higher weight proportion of only a few auxiliary substances.
Preferred embodiments contain as auxiliary substances or secondary constituents several or most of the following substances:
a) Highly disperse amorphous silicon dioxide (silica). This is used as a pressing aid and lubricant. It is generally present in quantities of 0.25 to 2 wt. %, particularly 0.5 to 1 wt. %.
b) Sodium carboxymethyl cellulose. This can be present in the form of different types, particularly with a degree of substitution of 0.75 to 0.8. Sodium carboxymethyl cellulose acts both as a binder and as a solubilizer (disintegrating agent). It is generally present in quantities of 1 to 3 wt. %, particularly 1.5 to 2 wt. %.
c) Sodium carboxymethyl starch and/or sodium-starch-glycolate. The latter is in particular an excellent disintegrating agent. The quantities are generally 0.5 to 4 wt. %, particularly 1 to 2.5 wt. %. Croscarmellose (AVEBE) is also suitable as a disintegrating agent.
d) Corn starch, particularly prepasted corn starch. The latter serves as a disintegrating agent and cooperates in an excellent manner with sodium carboxymethyl starch and in particular sodium-starch-glycolate. The quantities are generally 0.5 to 10 wt. %, particularly 1 to 3 wt. %.
e) High purity microcrystalline cellulose. The latter has the function of a filler or binder and aids a homogeneous mixing during the mixing of the individual constituents. The quantities are generally 0.5 to 10 wt. %, particularly 1 to 3 wt. %.
f) Polyethylene glycols. These are generally present in the mixture as pulverulent solids. They have binder characteristics for the tablet, but also aid dissolving. The quantities are generally 1 to 5 wt. %, particularly 2 to 3 wt. %.
g) Gum Arabic. The latter serves as a binder and can in particular also be used in place of polyethylene glycols. The quantities are generally 0.5 to 5 wt. %, particularly 1 to 3 wt. %.
h) Magnesium stearate. This is a known pressing agent, which allows the tablet to have smooth surfaces and serves as a lubricant for the punch.
i) Sodium chloride (common salt). This is used for the electrochemical stabilization of chloramine-T at higher temperatures and under non-optimum storage conditions. The quantities are generally 1 to 5 wt. %, particularly 2 to 3 wt. %.
Apart from these constituents, for special application purposes further constituents can be present, such as e.g. antifoaming agents in water treatment and the like. Surfactants or detergents, together with dyes and perfumes can also be present. Stabilizing agents can also be used for ensuring storage stability and activity under extreme environmental conditions. These further constituents for special applications are added to the 100% of the aforementioned constituents. Surfactants can be present in quantities of 0.5 to 30 wt. %, particularly 0.5 to 2 wt. %, stabilizers in quantities of 0.5 to 20 wt. %, particularly 0.5 to 3 wt. %, dyes or perfumes in quantities of 0.5 to 20 wt. %, particularly 0.5 to 2 wt. % additionally to the 100%. Approximately 1 to 5 wt. % are sufficient for antifoaming agents. Generally the total quantity of the further constituents together is less than 10 wt. %. If the further constituents also have characteristics as pressing agents or solubilizers, the quantity of the aforementioned pressing agents and solubilizers can be reduced. The individual constituents can also be replaced by others having an equivalent action.
In particularly preferred embodiments of the invention there are at least 4, particularly at least
6
of
Bosch Hartmut
Georg Rolf
Fubara Blessing
Page Thurman K.
RMP chemisch-technische Spezialprodukte GmbH and Co. KG
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