Orally dissolvable nutritional supplement

Details Orally dissolvable nutritional supplement Orally dissolvable nutritional supplement

2000-03-31

2002-12-17

Paden, Carolyn (Department: 1761)

Food or edible material: processes, compositions, and products

Product with added vitamin or derivative thereof for...

C426S073000, C426S074000, C426S285000, C424S439000, C424S441000, C424S464000, C424S465000

Reexamination Certificate

active

06495177

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to chewable prenatal vitamin and mineral supplements that dissolve rapidly in the mouth.
BACKGROUND OF THE INVENTION
Vitamin, multi-vitamin and/or mineral preparations are commonly administered to inhibit, to prevent, or to reduce the frequency or severity of (i.e. “to alleviate”) specific medical disorders. Such preparations are also used as nutritional supplements. Pregnant women, in particular, are known to require significant dietary supplementation with iron, vitamins (e.g. folic acid), and non-ferrous minerals in order to minimize the risk of birth deformities in the fetus, to improve the chances of a successful delivery, and to improve birth weight of the fetus. Pregnant and lactating women commonly require iron- and vitamin-therapy to alleviate iron-deficiency anemia, and prenatal vitamin/mineral supplements are routinely prescribed for this purpose. Indeed, various patents are directed to improving the efficacy of iron supplementation for use during pregnancy.
Chewable multi-vitamin supplements are well known in the nutritional products industry. These vitamin-containing products typically provide a nutritious and bioavailable product and possess generally good palatability, or organoleptic effect. Developers of chewable nutritional supplements continually strive to develop chewable products having improved mouth feel and enhanced taste. This has been attempted in prior art products by adding taste masking agents or flavor enhancing agents (e.g. ethylmaltol) to the chewable tablet. Generally, however, the more vitamins and minerals a product contains, the less palatable it is, and substantially all of the prior art chewable multi-vitamin products have an unacceptable taste or mouth feel for one or more reasons.
A significant shortcoming of prior art chewable vitamin formulations (including prior art chewable prenatal vitamin/mineral supplements) is their inability to provide certain nutrients (e.g. iron and B vitamins) in a form that both is palatable and provides a nutritionally relevant amount of the nutrient(s) (e.g. the recommended daily allowance {R.D.A.} of the nutrient, as set forth by the U.S. Food and Drug Administration {F.D.A.} Center for Food Safety and Applied Nutrition). Numerous nutrients (iron, for example) have tastes which many individuals find to be disagreeable. Apart from the taste of a chewable nutritional supplement, the ‘mouth-feel’ of the supplement must also be taken into account. ‘Mouth-feel’ is a concept that encompasses non-taste-related aspects of the pleasantness experienced by a person while chewing or swallowing an nutritional supplement. Aspects of mouth-feel include, for example, the hardness and brittleness of a composition, whether the composition is chewy, gritty, oily, creamy, watery, sticky, easily dissolved, astringent, effervescent, and the like, and the size, shape, and form (tablet, powder, gel, etc.) of the composition.
Chewable dosage forms of a medication (e.g. chewable prenatal vitamin/mineral supplements) can be easily self-administered, and such dosage forms can be preferred when the likelihood of patient non-compliance with a dosing schedule of the medication is anticipated to be significant, such as when the consequence of failing to adhere to the schedule is not immediately apparent to the patient. For example, a woman may not realize or appreciate that failure to maintain proper nutrition in the early stages of pregnancy, and even prior to becoming pregnant, can significantly increase the risk of birth defects (e.g. failure to maintain a proper level of folate in the diet can increase the risk of neural tube-related birth defects). Side effects associated with an active ingredient in the medication (e.g. gastrointestinal discomfort associated with administration of iron in nutritional supplements) can further reduce patient compliance. Enhanced palatability of a chewable vitamin preparation (e.g. chewable prenatal vitamin/mineral tablets) can enhance patient compliance with a schedule of vitamin administration recommended by a medical practitioner for alleviation of a disease or disorder.
Even when patient compliance is not necessarily required for alleviation of a disease or disorder, differences in the palatability of vitamin preparations (particularly including chewable preparations) can strongly influence an individual's selection of one product from a multitude of available products.
The shortcomings of prior art chewable vitamin supplements have been recognized, but have not been satisfactorily overcome. Some prior art compositions, for example, have avoided unpleasant taste issues by omitting bad-tasting nutrients from the composition. Of course, where the bad-tasting nutrient is a nutrient which is intended to be administered as a part of the composition (e.g. iron and folic acid in a prenatal vitamin supplement), this option is not available. In other prior art compositions, manufacturers have attempted to mask the unpleasant taste of some nutrients. Taste masking technology for the preparation of multi-vitamin tablets can involve encapsulation of one or more nutrients, or addition of sugars, sweeteners, flavoring agents, or some combination of these, to the vitamin-containing composition before it is formulated into a tablet. A shortcoming of taste masking technology, particularly with regard to chewable formulations, is that very small quantities of bad-tasting nutrients can be detected by human taste buds. Thus, the amounts of sugars, sweeteners, and flavoring agents that would be necessary to render the taste of a nutrient undetectable would often be so great that the composition would be rendered unpalatable by these agents. Furthermore, coatings can break down or fail in the compressive, abrasive, and solution conditions which exist in the human mouth during mastication, and such breakdown or failure can lead to release of a taste-detectable amount of nutrient.
A need exists for vitamin-containing nutritional supplements, particularly those amenable for pre- and post-natal use in women, which are in a chewable form, but which do not exhibit the taste- and mouth feel-related shortcomings of prior art chewable vitamin formulations.
Examples of commercially available prenatal multivitamin tablets include PRENATAL-S™, STUART PRENATALS™, THERAGENERIX-M™, NATURE MADE LABS PRENATAL VITAMINS™, BEK™, ZENATE™, ZETAVITE™, NATABEC-RX™, CHENATAL™, ENFAMIL NATALINS™, PRENATAL S™, PRENAVITE™, FEMNATAL™, MATERNA™, PRENAKARE™, PRENATAL “1+1”, PRENATE 90™, PRENATE ULTRA™, and PRENATIN-F™, among others.
Simethicone (dimethyl polysiloxane) is an agent which is used for treatment of upset stomach, bloating, gastritis, and flatulence. Simethicone acts as a gastric de-foaming agent to decrease stomach gas. It is often included in antacid products and is available in both liquid and solid dosage forms. Commercially available chewable tablet dosage forms of simethicone include GAS RELIEF™, GAS-X™, GENASYME™, MAJOR-CON™, MI-ACID™, and PHAZYME™. When used in preparation of oral tablet formulations, simethicone is ordinarily used in the form of a granular solid in order to facilitate distribution of the anti-gas agent.
Simethicone has also been used as a pharmaceutical excipient in topical formulations such as ointments and skin protectants.
U.S. Pat. No. 4,710,387 to Uiterwaal et al. discloses a nutritional supplement preparation for pregnant and breast-feeding women which contains 10-20% by weight protein, 16-28% by weight fat, 43-65% by weight carbohydrates, and at most 3.5% by weight moisture, minerals, trace elements, and vitamins.
U.S. Pat. No. 5,869,084 to Paradissis et al. discloses a group of multi-vitamin and mineral supplements for women which are designed to meet the nutritional requirements for women at the various stages of their lives.
U.S. Pat. No. 5,494,678 to Paradissis et al. discloses a group of multi-vitamin and mineral supplements for pregnant women which are designed to maximize fetal development and maternal health during

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