Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2002-03-11
2004-11-02
Hartley, Michael G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S464000, C424S465000, C424S043000, C424S725000, C514S960000
Reexamination Certificate
active
06811793
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to formulating effervescent compositions that include stevia.
Effervescent compositions, when placed in water, evolve gas bubbles as they disintegrate. Effervescent compositions often exist in powder and tablet forms. Effervescent tablets are a useful dosage form for delivering active agents because they can be packaged in discreet and controlled quantities.
Effervescent tablets are often mass-produced using punch and die presses. The process of producing tablets, known as “tableting” or “compressing” requires the presence of a lubricant. The lubricant assists in reducing the friction that arises during the processes of compressing and ejecting the tablet. The absence of a lubricant can cause the tablet composition to stick to the punch face and the die wall of the tablet making apparatus, which can lead to irregular shaped tablets and a non-uniform distribution of ingredients within the tablet. These problems can be exacerbated in high speed tableting processes.
Lubricants can present difficulties when formulating effervescent compositions. Effervescent tablets preferably exhibit a fast rate of disintegration so that carbonate is present when the resulting composition is consumed and consumer preparation time inherent in the effervescent dosage form is minimized. Many lubricants retard the rate of disintegration.
In addition, consumers tend to prefer an effervescent tablet that dissolves in water to form a clear solution. Lubricants can cause “scumming” or agglomeration. Scumming refers to the presence of scum at the surface of the water in which the effervescent tablet has been dissolved. Scum is aesthetically undesirable and consumers tend to avoid using a dosage form that exhibits such a property. Stearates are one example of a class of water insoluble lubricants that tend to leave a scum on the surface of water.
Some consumers prefer compositions that include natural ingredients. Stevia is a natural extract found in the plant stevia rebaudiana and has sweetening properties. Other sweeteners such as aspartame, acesulfame potassium, cyclamate salts, and saccharin are synthetic.
SUMMARY
In one aspect, the invention features a tablet that includes stevia, water soluble binder, water soluble lubricant, active agent, and effervescent agent, the tablet exhibiting a hardness of at least 3 kp and being capable of disintegrating in water having a temperature of about 25° C. in less than 2.5 minutes. In one embodiment, the tablet exhibits a hardness of at least 6 kp. In another embodiment, the tablet disintegrates in no greater than 2 minutes in water having a temperature of about 25° C. In some embodiments, the tablet is essentially free of oil. In other embodiments, the tablet forms an essentially clear solution when disintegrated in water.
In one embodiment, the active agent is selected from the group consisting of water soluble active agents, substantially water dispersible active agents and combinations thereof. In some embodiments, the active agent includes vitamin, amino acid, pharmaceutical agent, mineral, dietary supplement or a combination thereof. In one embodiment, the active agent includes amino acid. In some embodiments, the active agent includes amino acid selected from the group consisting of L-tyrosine, isoleucine, ornithine, glutamine, phenylalanine, leucine, lysine, methionine, threonine, taurine, tryptophan, valine, alanine, glycine, arginine, histidine, cysteine, asparagine, proline, serine and mixtures thereof.
In one embodiment, the tablet further includes flavor agent, color agent, a sweetener, or a combination thereof.
In some embodiments, the effervescent agent includes an effervescent couple including acid and carbonate base. In other embodiments, the acid is selected from the group consisting of citric acid, tartaric acid, malic acid, fumaric acid, adipic acid, acid citrates, succinic acid and mixtures thereof. In another embodiment, the carbonate base is selected from the group consisting of sodium carbonate, potassium carbonate, sodium bicarbonate, potassium bicarbonate, calcium bicarbonate, magnesium carbonate, sodium glycocarbonate, carboxylysine and mixtures thereof.
In other embodiments, the water soluble lubricant includes polyethylene glycol. In some embodiments, the water soluble lubricant includes sodium benzoate. In one embodiment, the water insoluble lubricant includes from about 1% by weight to about 3% by weight sodium benzoate. In another embodiment, the composition is essentially free of water insoluble lubricant.
In one embodiment, the tablet includes from about 0.5% by weight to about 3% by weight stevia.
In other embodiments, the tablet includes stevia, water soluble binder, water soluble lubricant, active agent, and effervescent agent, the tablet, when disintegrated in water, forms an essentially scum free composition. In one embodiment, the tablet forms an essentially clear solution when dissolved in water.
In another embodiment, the tablet that includes stevia, water soluble binder, water soluble lubricant, active agent, effervescent agent, and no greater than 0.1% by weight water insoluble lubricant. In other embodiments, the tablet disintegrates in water having a temperature of about 25° C. in less than 2.5 minutes.
In some embodiments, the tablet includes stevia, polyethylene glycol, sodium benzoate, active agent, effervescent agent, and no greater than 1% by weight oil. In one embodiment, the tablet is essentially free of water insoluble lubricant. In another embodiment, the tablet is essentially free of oil. In other embodiment, the tablet disintegrates in less than 2.5 minutes in water at about 25° C. In some embodiments, the tablet disintegrates in less than 2 minutes in water at about 25° C.
In one embodiment, the tablet includes at least about 0.3% by weight stevia, from about 0.1% by weight to about 15% by weight polyethylene glycol and from about 0.1% by weight to about 15% by weight sodium benzoate. In some embodiments the tablet includes from about 0.5% by weight to about 3% by weight stevia, from about 1% by weight to about 5.5% by weight polyethylene glycol, and from about 1% by weight to about 3% by weight sodium benzoate.
In another aspect the invention features a tablet that includes stevia, water soluble binder, at least 3% by weight water soluble lubricant, active agent, and effervescent agent.
In other aspects the invention features a composition that includes stevia, water soluble binder, water soluble lubricant, and effervescent agent the composition forming an essentially scum free composition when disintegrated in water. In some embodiments, the composition dissolves in water to form an essentially clear solution. In other embodiments, the composition further includes active agent.
In one embodiment the composition includes stevia, water soluble binder, sodium benzoate, active agent, effervescent agent, and no greater than 1% by weight oil.
In other aspects, the invention features a method for treating a mammal that includes disintegrating an above described tablet or composition in liquid to form a composition, and administering the composition to the mammal. In some embodiments, the method for treating a mammal includes disintegrating an above-described tablet or composition in liquid to form a composition, and administering the composition to the mammal.
The effervescent composition provides an effervescent tablet that includes a natural sweetener. The effervescent tablet can be formulated to quickly dissolve in water to a clear solution that is free of an undesirable amount of scum. The effervescent tablet can also be formulated to exhibit a disintegration time of less than 2.5 minutes.
Other features of the invention will be apparent from the following description of preferred embodiments thereof, and from the claims.
REFERENCES:
patent: 4082858 (1978-04-01), Morita et al.
patent: 4127645 (1978-11-01), Witzel et al.
patent: 4147768 (1979-04-01), Shaffer et al.
patent: 4267164 (1981-05-01), Yeh et al.
patent: 4552771 (1985-11-01), Fülberth et al.
p
Allison Johnson, P.A.
Amerilab Technologies, Inc.
Gollamudi Sharmila S.
Hartley Michael G.
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