Anti-nausea compositions and methods

The present disclosure is directed to novel nutritional anti-nausea compositions, anti-emetic compositions, and methods of using same. The compositions provide improved relief from nausea and/or vomiting. The compositions are particularly useful for pregnant women.

BACKGROUND OF THE INVENTION
 1. Field of the Invention
 The present invention is directed to novel nutritional anti-nausea
 compositions, anti-emetic compositions and methods of using the same to
 provide relief from nausea and/or vomiting. The present compositions are
 also nonteratogenic and are therefore highly useful to pregnant women.
 2. Description of the Related Art
 Nausea and vomiting are two of the most common symptoms of illness and are
 also commonly experienced as side effects of numerous medical treatments.
 Both nausea and vomiting are also commonly experienced as a result of
 various external factors (e.g., travel) and during various conditions
 (e.g., pregnancy). Nausea and vomiting can occur individually or in
 conjunction with one another.
 A common cause of nausea and vomiting is motion sickness. Motion sickness
 typically occurs when humans are subjected to long-lasting external
 movement or transportation accompanied by unusual movements such as
 shaking, waving, atmospheric changes (e.g., flying in an airplane), great
 acceleration, and uneven road conditions, etc. Motion sickness is not
 viewed as a disease but as a physiological symptom complex wherein the
 symptoms experienced, of which nausea and vomiting are common, depend on
 the individual in question. When the individual experiences motion
 sickness in a work environment, i.e., truck drivers, air pilots, air craft
 staff members and the like, the potential for a disadvantageous and
 dangerous condition result. Such individuals are often required to exhibit
 high level concentration and intellect, and the presence of motion
 sickness symptoms can severely detract from their ability to do so.
 Though experienced by a more limited number of individuals, the nausea and
 vomiting associated with chemotherapy drugs and radiation treatment is
 especially problematic. Cancer treatment drugs such as Cisplatinum,
 Streptozotocin, Cytoxan, Nitrogen Mustard and Ara-C are known to cause
 severe nausea and vomiting as side effects. The reason that cancer drugs
 cause nausea and vomiting is still under investigation. It is believed
 that the drugs stimulate and irritate specific key areas in the brain
 which results in nausea and vomiting. Individuals undergoing cancer
 treatments and experiencing these side effects may feel discouragement
 beyond that which is directly related to their cancer. The inability to
 eat normally or to alleviate nausea can lead to increased patient
 depression. The Merck Manual, 1281-87 (16th Ed. 1992).
 Postoperative nausea and vomiting is one of the most common side effects,
 estimated to be experienced by 20% to 30% of patients, after undergoing
 anesthetic and surgical procedures. Coates, A., "On the receiving
 end-patient perception of the side-effects of cancer chemotherapy", Eur J
 Cancer Clin Oncol, 19:203-208 (1983); See also, Cooper, et al., "The
 impact of cytotoxic chemotherapy-perspectives from patients, specialists
 and nurses", Eur J Cancer Clin Oncol, 28A(suppl 1):S36-S38 (1992).
 Research shows the occurrence of postoperative nausea and vomiting to be
 from 25% to 55% following inpatient surgery and from 8% to 47% for
 outpatient procedures. Id.; See also, Laszlo, J., "Nausea and vomiting as
 major complications of cancer chemotherapy", Drugs, 25(suppl 1):1-7
 (1983); See also, Tortorice, et al., "Management of chemotherapy-induced
 nausea and vomiting", Pharmacotherapy, 10:129-145 (1990). When questioned
 prior to surgery, patients are often more concerned about post-operative
 nausea and vomiting than post-operative pain, since they perceive that the
 nausea and vomiting will be more debilitating. Tonato, et al.,
 "Methodology of antiemetic trials: a review", Ann Oncol, 2:107-114 (1991);
 See also, Fauser, et al., "Therapeutic equivalence of single oral doses of
 dolasetron mesilate and multiple doses of ondansetron for the prevention
 of emesis after moderately emetogenic chemotherapy," Eur J Cancer,
 32A(9):1523-1529 (1996).
 Nausea and vomiting are also both common in early pregnancy. Cases can
 range in degree from mild to severe, and symptoms usually begin soon after
 the first missed period. Morning sickness, i.e., nausea and vomiting
 experienced during the first and second trimesters of pregnancy, is
 experienced by approximately half of all pregnant women, however it is
 particularly common in cases of multiple pregnancy and hydatidiform mole.
 Kousen, M., "Treatment of nausea and vomiting in pregnancy", Am Fam
 Physician, 48:1279 (1993).
 Hyperemesis gravidarum, i.e., persistent nausea and vomiting during
 pregnancy, can lead to a reduction in fluid and electrolyte levels, as
 well as a jeopardized nutritional status if the condition is not treated.
 The condition is characterized by prolonged and severe nausea and
 vomiting, dehydration, ketosis, and body weight loss. Other complications
 may include hyponatraemia, hypokalaemia, a low serum level, metabolic
 hypochloraemic alkalosis, ketonuria, liver function test abnormalities,
 abnormal thyroid function tests, and suppressed thyroid-stimulating
 hormone levels. Nelson-Piercy, C., "Treatment of nausea and vomiting in
 pregnancy. When should it be treated and what can be safely taken?", Drug
 Saf, 19(2):155-64 (1998).
 Nausea and vomiting can also be brought on by a variety of other causes
 such as reactions to certain types of odors or visual stimuli,
 psychological perceptions, allergic reactions, drug interactions and the
 like. Whatever the cause, the presence of a nauseated and/or emetic
 condition in an individual can be debilitating for the period during which
 it is experienced, and therefore numerous antiemetic and antinausea
 compositions and methods have been described.
 Many generalized nausea and vomiting treatment compositions have been
 described. For example, Tyers et al., U.S. Pat. No. 5,578,628, describe
 tetrahydrocarbazolone derivatives which may be used for the prevention and
 treatment of nausea.
 Lovgren et al., U.S. Pat. No. 4,786,505, describe a pharmaceutical
 preparation containing omeprazole for oral use and a method of affecting
 gastric acid secretion and providing gastrointestinal cytoprotective
 effect when using them.
 Lovgren, U.S. Pat. No. 4,853,230, describes an easily water soluble
 pharmaceutical preparation containing an acid labile compound together
 with and alkaline reacting compound for the treatment of gastrointestinal
 diseases.
 Bodo et al., U.S. Pat. No. 4,925,878, describe a composition especially
 suited for the treatment of the nausea and vomiting symptoms associated
 with motion sickness.
 Numerous drugs have been developed for the treatment of
 chemotherapy-induced vomiting and nausea. Zofran.RTM., a prescription
 antiemetic drug containing ondansetron as the active component, is a
 highly selective antagonist of serotonin receptors. Clinically accepted
 for use in treating cancer chemotherapy-induced nausea and vomiting,
 post-operative nausea and vomiting, and radiotherapy induced nausea and
 vomiting, this medication is not accepted for use in the treatment of
 motion-sickness or for prescription to pregnant or nursing women. Drug
 Information for the Health Care Professional, 2179 (17.sup.th Ed., 1997).
 Kytril.RTM., another prescription antiemetic, containing the active
 component granisetron, also works as a highly specific antagonist of
 serotonin receptors. Clinically, Kytril.RTM. is only accepted for use in
 treating cancer chemotherapy-induced nausea and vomiting and has not been
 proven safe for prescription to pregnant or nursing women. Id. at 1532.
 In relation to the treatment of nausea and/or vomiting in pregnant women,
 different approaches have been attempted in order to avoid teratogenicity
 or at least reduce the risk of birth defects commonly associated with
 certain drugs for treating nausea and vomiting.
 Studies have shown that certain vitamins may reduce nausea and/or vomiting.
 Administration of pyridoxine was shown to be effective in relieving the
 severity of nausea in early pregnancy without being teratogenic.
 Vutyavanich, et al., "Pyridoxine for nausea and vomiting in pregnancy:
 a randomized, double-blind, placebo-controlled trial", Am J Obstet Gynecol,
 173:881-4 (1995).
 Further, it has been shown that the nausea and vomiting of pregnancy can be
 mitigated if the patient eats small portions of food at frequent
 intervals, increases the amount of carbohydrates, decreases the amount of
 fat, and avoids "bothersome food odors." Kousen, M., "Treatment of nausea
 and vomiting in pregnancy", Am Fam Physician, 48(7):1279-84 (1993).
 Nutritional compositions for general improvement of health have been
 described in the related art. Green, U.S. Pat. No. 4,806,345, describes a
 health food composition which is comprised of B complex vitamins, i.e.,
 thiamine, pyridoxine, riboflavin, and cyanocobalamin, an emulsifying
 agent, flavoring agent, a preservative agent and optionally an antacid
 such as calcium carbonate and/or an analgesic such as acetaminophen.
 Meshansho, et al., U.S. Pat. No. 4,994,283, describe a nutritional
 composition comprised of iron compounds and calcium compounds in
 combination with citrates or tartrates, ascorbates, and, optionally,
 fructose.
 Clark, U.S. Pat. No. 4,738,856, describes a yet another nutritional
 composition in the form of a beverage solution, which comprises calcium,
 magnesium, potassium, a sweetener agent and a stabilizer. The invention is
 specifically designed to have a reducing effect on conditions such as high
 blood pressure and high blood alcohol content.
 It is generally accepted that it is of significant advantage under certain
 circumstances to both patients, physicians and nonpatients that
 medications and/or nutritional compositions be formulated so that they may
 be administered in a minimal number of daily doses from which the
 medication and/or nutritional composition is uniformly released over a
 desired, extended period of time. Such delivery methods are particularly
 useful for the sake of convenience when repeat dosing is necessary to
 bring about a desired therapeutic or physiological effect. Such delivery
 systems have been described.
 Ayer et al., U.S. Pat. No. 4,948,592, describe a pulsed drug delivery
 system comprising an immediately available dose of a beneficial drug
 followed by a timed delayed dose of the drug, or simply a timed delayed
 dose of the drug.
 Guley et al., U.S. Pat. No. 4,309,405, describe a sustained release tablet
 wherein the active drug in a core structure of the tablet surrounded by a
 water soluble polymer such hydroxypropylmethylcellulose or
 hydroxypropylcellulose and a water insoluble polymer such as
 ethylcellulose.
 Another form of drug delivery which has been accepted as useful to both
 patients, physicians and nonpatients is the chewable tablet dosage form.
 This type of dosing finds particular applicability in persons who have
 difficulty swallowing tablet-type forms of medications and/or nutritional
 compositions or when the substance contained within the tablet is most
 beneficial when delivered immediately, such as with antacid formulations.
 Chewable tablets forms have been described in the art.
 Weckenamnn et al., U.S. Pat. No. 5,648,092, describe pharmaceutical
 compositions in the form of pleasant tasting chewable tablets containing
 sulcralfate, which is employed for the treatment of duodenal ulcers,
 gastric ulcers and reflux esophagitis.
 While numerous antiemetic compositions and methods exist, these
 compositions often produce numerous and undesired patient side-effects.
 These formulation have the result of placing the patient in the position
 of choosing between the condition she or he seeks to alleviate and the
 side effect of the therapy. Further, these formulations do not utilize
 vitamins and minerals as active components, and therefore have no direct
 positive impact on the patient's nutritional status. Thus, it is desirable
 to have effective antiemetic formulations which have few side effects and
 are nutritionally beneficial to the taker.
 The disclosed antiemetic compositions are deficient in various other
 respects. Primarily, none have undergone extensive clinical studies on
 humans with regards to teratogenicity, and thus are not recommended for
 ingestion by pregnant women except for in the most extreme of situations.
 Even the above discussed references which recognize the potential for
 teratogenicity, and thus seek to provide for alternative methods of
 treatment, do not specifically disclose distinct nutritional formulations
 for treating nausea and vomiting. Further these references do not provide
 any guidance with regard to formulating nutritional compositions for
 treating nausea and vomiting.
 Therefore, it is desirable to have formulations available which are
 effective in providing relief to nausea and vomiting arising from various
 causes. Moreover, there is a particular need for formulations which
 simultaneously relieve nausea and/or vomiting and provide a higher degree
 of patient compliance and are available at minimal cost. Additionally,
 there remains a need for specific nutritional formulations which have an
 antiemetic effect, are nonteratogenic, and also support good health. It is
 also particularly desirable to have formulations available which minimize
 the need to take medications and which are suitable to be taken by
 individuals who seek to limit their use of medications. Thus, there is a
 general overall need for a fundamentally new, safe, effective and
 comprehensive approach to addressing the treatment of nausea and vomiting
 arising from various causes.
 SUMMARY OF THE INVENTION
 The present invention overcomes the deficiencies of currently available
 antiemitic and antinausea compositions in a number of ways. First, the
 present nutritional compositions do not possess teratogenic
 characteristics. The present invention also can be taken in conjunction
 with medications and presents minimal risk of interaction. Furthermore,
 the formulations of the invention have been found to reduce the occurrence
 of nausea and vomiting in pregnant women experiencing morning sickness or
 hyperemisis gravidarum and in persons undergoing cancer treatments such as
 chemotherapy or radiation therapy. The compositions of the invention also
 include method of dosing, i.e., pulsed delivery or chewable, which present
 useful and convenient options for the patient, physician and nonpatient.
 Thus, the invention provides for anti-nausea nutritional compositions which
 are designed to provide relief from nausea when administered to an animal,
 i.e., human, mammal or any other animal, which comprises a vitamin B.sub.6
 compound or derivative thereof in an amount ranging from about 20 mg to
 125 mg per 55 kg of body weight; an alkaline buffering agent in an amount
 sufficient to provide a pH buffering effect in said animal's
 gastrointestinal tract; an acceptable coating agent; and wherein the
 vitamin B.sub.6 compound or derivative thereof is separated from the
 alkaline buffering agent by said acceptable coating agent.
 The invention also provides for a solid anti-nausea nutritional composition
 which is designed to provide relief from nausea when administered to an
 animal, which comprises: a vitamin B.sub.6 compound or derivative thereof
 in an amount ranging from about 20 mg to 125 mg per 55 kg of body weight;
 and an alkaline buffering agent in an amount sufficient to provide a pH
 buffering effect in said animal's gastrointestinal tract.
 The invention further provides for an anti-nausea nutritional composition
 which is designed to provide relief from nausea when administered to an
 animal, which comprises: a vitamin B.sub.6 compound or derivative thereof
 in an amount ranging from about 20 mg to 125 mg per 55 kg of body weight;
 a folic acid compound or derivative thereof in an amount ranging from
 about 0.1 mg to 2 mg per 55 kg of body weight; an alkaline buffering agent
 in an amount sufficient to provide a pH buffering effect in said animal's
 gastrointestinal tract; an acceptable coating agent; and wherein the
 vitamin B.sub.6 is separated from the alkaline buffering agent by said
 acceptable coating agent.
 The invention additionally provides for an anti-nausea nutritional
 composition which is designed to provide relief from nausea when
 administered to an animal, which comprises: a vitamin B.sub.6 compound or
 derivative thereof in an amount ranging from about 20 mg to 125 mg per 55
 kg of body weight; an alkaline buffering agent in an amount sufficient to
 provide a pH buffering effect in said animal's gastrointestinal tract; and
 means for providing pulsed or timed delayed dosing of said vitamin B.sub.6
 compound or derivative thereof and said alkaline buffering agent.
 The invention further provides for an anti-nausea and antiemetic
 nutritional composition which is designed to provide relief from nausea
 and vomiting when administered to an animal, which comprises: a vitamin
 B.sub.6 compound or derivative thereof in an amount ranging from about 20
 mg to 125 mg per 55 kg of body weight; and an alkaline buffering agent in
 an amount sufficient to provide a pH buffering effect in said animal's
 gastrointestinal tract.
 The invention likewise provides for an anti-nausea nutritional composition
 which is designed to provide relief from nausea when administered to an
 animal, which comprises: a vitamin B.sub.6 compound or derivative thereof
 in an amount ranging from about 20 mg to 125 mg per 55 kg of said animal's
 body weight; an alkaline buffering agent in an amount sufficient to
 provide a pH buffering effect in said animal's gastrointestinal tract; and
 a B vitamin selected from the group consisting of thiamin, riboflavin,
 niacin, biotin, pantothenic acid, folate, folic acid, and cobalamin.
 The invention also provides a method for treating nausea in an animal,
 which comprises: administering to said animal a therapeutically effective
 amount of a composition comprising: a vitamin B.sub.6 compound or
 derivative thereof in an amount ranging from about 20 mg to 125 mg per 55
 kg of body weight; an alkaline buffering agent in an amount sufficient to
 provide a pH buffering effect in said animal's gastrointestinal tract; an
 acceptable coating agent; and wherein the vitamin B.sub.6 is separated
 from the alkaline buffering agent by said acceptable coating agent.
 Another aspect of the present invention is a method for treating nausea or
 vomiting in a pregnant woman, which comprises: administering to said
 pregnant woman a therapeutically effective amount of a composition
 comprising a vitamin B.sub.6 compound or derivative thereof in combination
 with an alkaline buffering agent.
 A further aspect of the invention is a method for treating nausea in a
 pregnant woman, which comprises: administering to said pregnant woman a
 therapeutically effective amount of a composition comprising a vitamin
 B.sub.6 compound or derivative thereof in combination with an alkaline
 buffering agent; and simultaneously applying controlled pressure to an
 acupressure site on said pregnant woman.
 A still further aspect of the invention is a method for treating
 hyperemesis gravidarum in a pregnant woman, which comprises: administering
 to said pregnant woman a therapeutically effective amount of a composition
 comprising a vitamin B.sub.6 compound or derivative thereof in combination
 with an alkaline buffering agent.
 The invention likewise provides for a method for preventing the nausea
 associated with pregnancy, which comprises administering a vitamin B.sub.6
 compound or derivative thereof in an amount ranging from about 20 mg to
 125 mg per 55 kg of said animal's body weight and an alkaline buffering
 agent in an amount sufficient to provide a pH buffering effect in said
 animal's gastrointestinal tract in combination with a prenatal vitamin
 regimen.
 Another embodiment of the invention is a kit for treating nausea or
 vomiting in an animal, which comprises: a vitamin B.sub.6 compound or
 derivative thereof in combination with an alkaline buffering agent; and an
 apparatus for applying controlled pressure to an acupressure site on said
 animal.
 DETAILED DESCRIPTION OF THE INVENTION
 As used herein, "continuous nausea relief" refers to the alleviation of the
 symptom of nausea during each 24 hour period of time during which the
 present compositions are administered.
 "Continuous vomiting relief" refers to the alleviation of the symptom of
 vomiting during each 24 hour period of time during which the present
 compositions are administered.
 "Animal" refers to a human, mammal or any other animal.
 "Nausea associated with pregnancy" refers to morning sickness, evening
 sickness and hyperemesis gravidarum, without limitation.
 "Pulsed delivery" refers to a delivery method which supplies repetitive
 doses of a composition from a single administration.
 "Timed delivery" refers to a delivery method which supplies repetitive
 doses of a composition in pre-determined amounts at pre-determined times
 after administration.
 "Targeted time period" refers to the period of time during which nausea and
 vomiting are anticipated or expected to occur.
 "Targeted time delivery" refers to a delivery method which supplies a
 dosage or dosages of the composition in conjunction with the occurrence of
 the period of time during which nausea and vomiting are anticipated or
 expected to occur.
 The present invention is based in part on the discovery that certain
 vitamins, minerals and other nutrients and their components and
 compositions can produce specific physiological effects beyond their usual
 function of maintaining good health and well being. Specifically, certain
 conditions are treatable with the administration of certain nutritional
 compositions. Furthermore, in some cases treatment of specific conditions
 with nutritional compositions, as opposed to pharmaceutical compositions,
 is quite desirable due to the fact that nutritional compositions produce
 few side effects and along with treating the condition in question,
 nutritional compositions have positive effects upon the taker's health.
 Moreover, the present invention is based, in part, upon the realization
 that the type of dosage form used with the specific nutritional component
 is significant and can result in synergistically improved efficacy. The
 present compositions are particularly effective when formulated into a
 pulsed release dosage form.
 The present inventive subject matter recognizes that there are substantial
 physiological benefits to be attained from specific formulations of
 vitamins and minerals to person who are experiencing nausea and/or
 vomiting.
 The present compositions and methods are also effective in preventing and
 treating nausea and/or vomiting in persons undergoing medical treatment
 involving drugs which may negatively interact with prescription gastric
 neutralizing agents, as well as persons simply seeking to minimize
 medication intakes.
 Furthermore, pregnant women, who comprise a large portion of the
 individuals who experience nausea and vomiting, must be cautious of
 teratogenic substances, such as those potentially contained in other
 anti-nausea and anti-emetic compositions. Thus, pregnant women should
 avoid such compositions and seek out treatments which are accepted as
 nonteratogenic. The products of the invention provide for nutritional
 compositions which provide relief from nausea and vomiting and are
 accepted as nonteratogenic. Thus, the products of the invention are ideal
 for administration to pregnant women.
 Furthermore, the present inventive subject matter recognizes the corollary
 benefits of the administration of antinausea and antiemetic compositions
 in a preventative manner. A patient who believes that he or she will be
 subject to the conditions of nausea and vomiting in the future may
 experience mental stress and/or anxiety based upon this belief. For
 example, a person with a history of motion sickness may be reluctant to
 travel, even for pleasure, because the motion sickness detracts from the
 positive aspects of the experience. Thus, such a person may become
 distressed at the contemplation of travel wherein his or her presence is
 required or mandated, i.e., a family or business related trip.
 Likewise, a pregnant woman, who is prone to but not currently experiencing
 morning sickness, may feel a certain sense of foreboding. She is well
 aware that in the near future she will become nauseous and vomit despite
 the fact she presently feels normal. Such knowledge detracts from her
 current peace of mind and may lead to anxiety. By administering the
 compositions of the present invention in a prophylactic manner,
 individuals similar to the ones described may experience a certain sense
 of calm and increased well being, as well as a reduction in anxiety, due
 to the fact that they have been able to take a pro-active course of action
 with regards to their conditions.
 Without being limited by theory, the compositions, methods and kits of the
 present invention may be effective because they provide vitamins, minerals
 and other nutrients which mitigate nausea and vomiting. Alternatively, the
 compositions and methods may be effective because they aid in the
 metabolic processes and/or other physiological reactions which prevent
 nausea and vomiting.
 The nutritional compositions of the present invention contain specific
 concentrations of vitamins and minerals for administration to individuals
 currently experiencing nausea and vomiting, individuals predisposed to
 nausea and vomiting, or individuals who would reasonably anticipate such
 symptoms in the near future. The compositions of the invention also
 provide safe and effective vitamins and minerals which are recognized as
 required in daily amounts by humans, and thus are beneficial to overall
 health.
 The nutritional compositions of the present invention may be formulated to
 provide continuous relief from nausea. The nature of the continuous relief
 is brought about from the time the individual begins metabolizing the
 first dosage of the composition during the twenty four hours or a lesser
 time than twenty four hours after the time the individual ceases use.
 Therefore, the alleviation of the symptoms will be constant throughout
 each twenty four hour period or a lesser time than twenty four hours
 during the entire time which the nutritional composition is taken on a
 regular daily basis.
 For example, if an individual takes the nutritional compositions for a
 period of a month, the individual could expect to experience greatly
 reduced occurrences of nausea during the entire duration of the month
 period.
 Furthermore, the compositions of the present invention may be formulated to
 provide short term relief from nausea as well. For example, an individual
 who anticipates experiencing nausea in the near future for a defined
 period of time, (e.g., during a boat ride) would benefit from ingesting
 the nutritional compositions of the present invention prior to this period
 of time. Further, this individual could expect to receive relief from the
 anticipated symptoms. The short term relief mechanism of this composition
 can also be utilized to provide relief from symptoms which the individual
 is presently experiencing. For example, an individual could ingest the
 compositions of the present invention while experiencing nausea in order
 to obtain relief from the symptoms.
 The nutritional compositions of the present invention are nonemetic, are
 formulated to act as anti-emetics and may provide continuous relief from
 vomiting. Here again, the continuous nature of the relief is affected from
 the time metabolization of the first dosage begins and lasts until about
 twenty four hours or a lesser time than twenty four hours after the time
 subsequent dosages are ceased, thus alleviating the symptoms for the
 period of time during when the nutritional composition is taken regularly.
 Additionally, the nutritional compositions of the present invention can
 provide short term relief from vomiting, either on an anticipatory basis,
 i.e., the individual expects to vomit, or on an alleviatory basis, i.e.,
 the individual is currently experiencing the symptom of vomiting.
 The present invention is also composed of accepted nonteratogenic
 compositions and is therefore safe for ingestion by pregnant women without
 fear of adverse affects (e.g., birth defects) upon the unborn child.
 Furthermore, a women who believes she may become pregnant or has recently
 learned that she is pregnant, could begin a regimen of the nutritional
 compositions of the present invention, either alone or in conjunction with
 a prenatal vitamin regime, in order to avoid the onset of symptoms of
 morning sickness and other forms of nausea associated with pregnancy.
 The nutritional compositions of the present invention are formulated to
 mitigate and/or alleviate nausea and vomiting. The extent to which the
 nausea and vomiting are mitigated and/or alleviated may be influenced by
 numerous external factors, such as the following, non-limiting examples:
 diet, alcohol consumption, drug use, poor compliance and the like.
 Moreover, the effectiveness of the compositions may vary from individual
 to individual for a wide variety of reasons, such as genetic
 predisposition, health factors, and the like, without limitation.
 The formulations of the present invention contain vitamin B.sub.6
 (pyridoxine) or derivatives thereof. Derivatives of vitamin B.sub.6
 include compounds formed from vitamin B.sub.6 which are structurally
 distinct from vitamin B.sub.6, but which retain the active function of
 vitamin B.sub.6. Such derivatives include, without limitation, pyridoxine,
 pyridoxal, pyridoxamine, pyridoxal phosphate, salts of vitamin B.sub.6,
 chelates of vitamin B.sub.6, combinations thereof and the like. The
 vitamin B.sub.6 may be present in a single form or in various different
 forms in combination within the present compositions. The specific amount
 of vitamin B.sub.6 in the compositions is adjusted based on the type of
 dosage form utilized (i.e., immediate release vs. controlled release) and
 tablet type (i.e., chewable).
 In the case of the immediate release compositions, the amounts of vitamin
 B.sub.6 in the compositions preferably range from about 10 mg to about 135
 mg per 55 kg of body weight. More preferably, the amounts of vitamin
 B.sub.6 in the immediate release compositions range from about 15 mg to
 130 mg per 55 kg of body weight. Even more preferably, the amounts of
 vitamin B.sub.6 in the immediate release compositions range from about 20
 mg to about 125 mg per 55 kg of body weight.
 The amount of vitamin B.sub.6 present in the controlled release
 compositions of the present invention, preferably range from about 65 mg
 to about 135 mg per 55 kg of body weight. More preferably, the amounts of
 the vitamin B.sub.6 present in the controlled release compositions range
 from about 70 mg to about 130 mg per 55 kg of body weight. Most
 preferably, the amounts of vitamin B.sub.6 in the controlled releases
 compositions range from about 120 mg to about 125 mg per 55 kg of body
 weight.
 The amount of vitamin B.sub.6 present in the chewable tablet type of the
 present invention, preferably ranges from about 25 mg to about 75 mg per
 55 kg of body weight. More preferably, the amounts of vitamin B.sub.6
 present in the controlled release compositions range from about 40 mg to
 about 60 mg per 55 kg of body weight. Most preferably, the amounts of
 vitamin B.sub.6 in the controlled releases compositions range from about
 45 mg to about 55 mg per 55 kg of body weight.
 The compositions of the present invention may include a folic acid compound
 or derivative thereof. The derivatives of folic acid include compounds
 formed from folic acid which are structurally distinct from folic acid,
 but which retain the active function of folic acid. Non-limiting examples
 of such derivatives include folate, folacin, pteroylglutamic acid,
 dihydrofolate, tetrahydrofolate, salts of folic acid, chelates of folic
 acid, combinations thereof and the like. Preferably, the amounts of folic
 acid in the immediate release compositions of the invention range from
 about 0.01 mg to about 3 mg per 55 kg of body weight of folic acid
 compound or derivative. Most preferably, the amounts of folic acid in the
 invention range from about 0.1 mg to about 2.0 mg per 55 kg of body
 weight. The amounts of folic acid in the controlled release compositions
 of the invention preferably range from about 0.1 mg to about 3 mg per 55
 kg of body weight. More preferably, the amounts of folic acid in the
 controlled release compositions range from about 0.5 mg to about 1.5 mg
 per 55 kg of body weight. Note that the amount of folic acid does not vary
 when the nutritional composition is in chewable tablet type form.
 The compositions of the present invention may optionally include a vitamin
 B.sub.12 compound or derivative thereof. The derivatives of vitamin
 B.sub.12 include compounds formed from vitamin B.sub.12 which are
 structurally distinct from vitamin B.sub.12, but which retain the active
 function of vitamin B.sub.12. Non-limiting examples of such derivatives
 include methylcobalamin, deoxyadenosylobalamin, salts of vitamin B.sub.12,
 chelates of vitamin B.sub.12, combinations thereof and the like.
 Preferably, the amounts of vitamin B.sub.12 in the immediate release
 compositions of the invention range from about 10 mg to about 15 mg per 55
 kg of body weight of vitamin B.sub.12 compound or derivative.
 Similarly, the amounts of vitamin B.sub.12 in the controlled release
 compositions of the invention preferably range from about 10 mg to about
 15 mg per 55 kg of body weight.
 The compositions of the invention may contain any additional vitamin,
 pharmaceutically acceptable mineral compound, or derivative thereof.
 Non-limiting exemplary vitamins for incorporation into the present
 invention include thiamin, riboflavin, niacin, biotin, pantothenic acid,
 folate, folic acid, cobalamin and combinations thereof. Non-limiting
 exemplary derivatives of vitamin compounds include salts, alkaline salts,
 esters and chelates of any vitamin compounds.
 The compositions of the present invention may optionally include a calcium
 carbonate compound or derivative thereof. Preferably, the amounts of
 calcium carbonate in the compositions of the invention range from about
 100 mg to about 550 mg per 55 kg of body weight of calcium carbonate
 compound or derivative. Even more preferably, the amounts of calcium
 carbonate in the compositions of the invention range from about 150 mg to
 about 500 mg per 55 kg of body weight. Most preferably, the amounts of
 calcium carbonate in the invention range from about 200 mg to about 450 mg
 per 55 kg of body weight. Note that the amount of calcium carbonate does
 not necessarily vary in the nutritional composition with regards to
 immediate vs. controlled release or in the chewable tablet form.
 The compositions of the present invention may optionally include one or
 more of the following: thiamin, thiamin pyrophosphate, riboflavin, flavin
 mononucleoride, flavin adenine dinucleotide, niacin, nicotinic acid,
 nicotinamide, niacinamide, nicotinamide adenine dinucleotide, tryptophan,
 biotin, pantothenic acid, ascorbic acid, retinol, retinal, retinoic acid,
 beta-carotene, 1,25-dihydroxycholecalciferol, 7-dehyrdocholesterol,
 alpha-tocopherol, tocopherol, tocotrienol, menadione, menaquinone,
 phylloquinone, naphthoquinone, phosphorus, potassium, sulfur, sodium,
 docusate sodium, chloride, magnesium, copper, iodine, zinc, chromium,
 molybdenum, and iron.
 The compositions of the present invention contain an alkaline buffering
 agent. The alkaline buffering agent may be selected from the following
 non-limiting examples: aluminum carbonate, aluminum hydroxide, aluminum
 phosphate, aluminum hydroxy carbonate, aluminum citrate, dihydroxyaluminum
 sodium carbonate, aluminum magnesium glycinate, dihydroxyaluminum
 aminoacetate, dihydroxyaluminum aminoacetic acid, bismuth aluminate,
 bismuth carbonate, bismuth subcarbonate, bismuth subgallate, bismuth
 subnitrate, calcium carbonate, calcium hydroxide, calcium phosphate,
 calcium citrate, calcium citrate malate, hydrated magnesium aluminate,
 activated sulfate, magnesium aluminate, magnesium aluminosilicates,
 magnesium carbonate, magnesium glycinate, magnesium hydroxide, magnesium
 oxide, magnesium trisilicate, potassium carbonate, potassium phosphate,
 potassium citrate, sodium carbonate, sodium bicarbonate, sodium phosphate,
 sodium citrate and mixtures thereof.
 Preferably, the amounts of alkaline buffering agent in the compositions of
 the invention range from about 100 mg to about 300 mg per 55 kg of body
 weight of alkaline buffering compound or derivative. Even more preferably,
 the amounts of calcium carbonate in the compositions of the invention
 range from about 150 mg to about 250 mg per 55 kg of body weight.
 The nutritional compositions of the present invention have a low moisture
 content. Preferably, the nutritional compositions of the present invention
 have a moisture content of less than 5%. More preferably, the moisture
 content is less than 2.5%. Even more preferably, the moisture content is
 less than 2%. Most preferably, the moisture content is less than 1%.
 The nutritional compositions of the present invention may also optionally
 include coating agents. Acceptable coating agents may be selected from the
 following, without limitation: cellulose dibutylaminohydroxypropyl ether,
 polyvinyl acetal diethylamino acetate, 2-methyl-5-vinylpyridine
 methacrylate-methacrylic acid copolymer, hydroxypropyl methyl cellulose
 phthalate, hydroxypropyl methyl cellulose acetate succinate, ethyl
 cellulose, cellulose acetate, cellulose acetate phthalate, cellulose
 propionate, cellulose butyratem cellulose valerate, cellulose acetate
 propionate, polyvinyl acetate, polyvinyl acetate phthaalate, polyvinyl
 formal, polyvinyl butyral, ladder polymer of sesquiphenyl siloxane,
 polymethyl methacrylate, poly carbonate, polystyrene, polyester,
 cumaroneindene polymer, polybutadiene, vinyl chloride-vinyl acetate
 copolymer, ethylene-vinyl acetate copolymer, vinyl
 chloride-propylene-vinyl acetate copolymer, poly(methacrylic acid, methyl
 methacrylate) 1:1, poly(methacrylic acid, ethyl acrylate) 1:1, beef
 tallow, whale wax, bees wax, paraffin wax, castor wax, myristic, palmitic,
 stearic and behenic acids, esters thereof and combinations thereof.
 It is also possible in the nutritional composition of the present invention
 for the dosage form to combine various forms of release, which include,
 without limitation, immediate release, extended release, pulse release,
 variable release, controlled release, timed release, sustained release,
 delayed release, long acting, and combinations thereof. The ability to
 obtain immediate release, extended release, pulse release, variable
 release, controlled release, timed release, sustained release, delayed
 release, long acting characteristics and combinations thereof is performed
 using well known procedures and techniques available to the ordinary
 artisan. Each of these specific techniques or procedures does not
 constitute an inventive aspect of this invention.
 Any pharmaceutically acceptable dosage form, as well as combinations
 thereof, is contemplated by the invention. Examples of such dosage forms
 include, without limitation, compressed tablets, film coated tablets,
 chewable tablets, quick dissolve tablets, effervescent tablets,
 reconstitutable powders, elixirs, liquids, solutions, suspensions,
 emulsions, tablets, multi-layer tablets, bi-layer tablets, capsules, soft
 gelatin capsules, hard gelatin capsules, caplets, lozenges, chewable
 lozenges, beads, powders, granules, dispersible granules, cachets,
 douches, suppositories, creams, topicals, inhalants, aerosols inhalants,
 patches, particle inhalants, implants, depot implants, ingestibles,
 injectables, infusions, health bars, liquids, animal feeds, cereal
 coatings, cereals, confections, foods, nutritive foods, functional foods
 and combinations thereof. The preparation of any of the above dosage forms
 is well known in the art.
 The following represent examples, without limitation, of acceptable methods
 of preparing some of the above-listed dosage forms. For example, animal
 feed may be by methods well known to persons of ordinary skill in the art.
 Animal feeds may be prepared by mixing the formulation with binding
 ingredients to form a plastic mass. The mass is then extruded under high
 pressure to form tubular (or "spaghetti-like") structures that are cut to
 pellet size and dried.
 Quick dissolve tablets may be prepared, for example, without limitation, by
 mixing the formulation with agents such as sugars and cellulose
 derivatives, which promote dissolution or disintegration of the resultant
 tablet after oral administration, usually within 30 seconds.
 Cereal coatings may be prepared, for example, without limitation, by
 passing the cereal formulation, after it has been formed into pellets,
 flakes, or other geometric shapes, under a precision spray coating device
 to deposit a film of active ingredients, plus excipients onto the surface
 of the formed elements. The units thus treated are then dried to form a
 cereal coating.
 For example, health bars may be prepared, without limitation, by mixing the
 formulation plus excipients (e.g., binders, fillers, flavors, colors,
 etc.) to a plastic mass consistency. The mass is then either extended or
 molded to form "candy bar" shapes that are then dried or allowed to
 solidify to form the final product.
 Soft gel or soft gelatin capsules may be prepared, for example, without
 limitation, by dispersing the formulation in an appropriate vehicle
 (vegetable oils are commonly used) to form a high viscosity mixture. This
 mixture is then encapsulated with a gelatin based film using technology
 and machinery known to those in the soft gel industry. The industrial
 units so formed are then dried to constant weight.
 Chewable tablets, for example, without limitation, may be prepared by
 mixing the formulations with excipients designed to form a relatively
 soft, flavored, tablet dosage form that is intended to be chewed rather
 than swallowed. Conventional tablet machinery and procedures, that is both
 direct compression and granulation, i.e., or slugging, before compression,
 can be utilized. Those individuals involved in pharmaceutical solid dosage
 form production are well versed in the processes and the machinery used as
 the chewable dosage form is a very common dosage form in the
 pharmaceutical industry.
 Film coated tablets, for example, without limitation, may be prepared by
 coating tablets using techniques such as rotating pan coating methods or
 air suspension methods to deposit a contiguous film layer on a tablet.
 This procedure is often done to improve the aesthetic appearance of
 tablets, but may also be done to improve the swallowing of tablets, or to
 mask an obnoxious odor or taste, or to improve to usual properties of an
 unsightly uncoated tablet.
 Compressed tablets, for example, without limitation, may be prepared by
 mixing the formulation with excipients intended to add binding qualities
 to disintegration qualities. The mixture is either directly compressed or
 granulated then compressed using methods and machinery quite well known to
 those in the industry. The resultant compressed tablet dosage units are
 then packaged according to market need, i.e., unit dose, rolls, bulk
 bottles, blister packs, etc.
 The present nutritional compositions are formulated for administration by
 any route, including without limitation, oral, buccal, sublingual, rectal,
 parenteral, topical, inhalational, injectable and transdermal. The
 physicochemical properties of nutritional compositions, their
 formulations, and the routes of administration are important in
 absorption. Absorption refers to the process of nutritional composition
 movement from the site of administration toward the systemic circulation.
 Most orally administered nutritional compositions are in the form of
 tablets or capsules primarily for convenience, economy, stability, and
 patient acceptance. They must disintegrate and dissolve before absorption
 can occur. Using the present invention with any of the above routes of
 administration or dosage forms is performed using well known procedures
 and techniques available to the ordinary skilled artisan.
 The present invention uses pharmaceutically acceptable carriers which may
 be prepared from a wide range of materials. Without being limited thereto,
 such materials include diluents, binders and adhesives, lubricants,
 plasticizers, disintegrants, colorants, bulking substances, flavorings,
 sweeteners and miscellaneous materials such as buffers and adsorbents in
 order to prepare a particular medicated composition.
 Binders may be selected from a wide range of materials such as
 hydroxypropylmethylcellulose, ethylcellulose, or other suitable cellulose
 derivatives, povidone, acrylic and methacrylic acid co-polymers,
 pharmaceutical glaze, gums, milk derivatives, such as whey, starches, and
 derivatives, as well as other conventional binders well known to persons
 skilled in the art, and combinations thereof. Exemplary non-limiting
 solvents are water, ethanol, isopropyl alcohol, methylene chloride or
 mixtures and combinations thereof. Exemplary non-limiting bulking
 substances include sugar, lactose, gelatin, starch, silicon dioxide and
 combinations thereof.
 The plasticizers used in the dissolution modifying system are preferably
 previously dissolved in an organic solvent and added in solution form.
 Preferred plasticizers may be selected from the group consisting of
 diethyl phthalate, diethyl sebacate, triethyl citrate, cronotic acid,
 propylene glycol, butyl phthalate, dibutyl sebacate, caster oil and
 mixtures thereof, without limitation. As is evident, the plasticizers may
 be hydrophobic as well as hydrophilic in nature. Water-insoluable
 hydrophobic substances, such as diethyl phthalate, diethyl sebacate and
 caster oil are used to delay the release of water-soluble vitamins, such
 as vitamin B.sub.6 and vitamin C. In contrast, hydrophilic plasticizers
 are used when water-insoluble vitamins are employed which aid in
 dissolving the encapsulated film, making channels in the surface, which
 aid in nutritional composition release.
 The compositions of the present invention are intended for use by humans
 and other animals, and both males and females. The dosages are adjusted
 according to body weight and thus are set forth herein on a per body
 weight basis. For example, where the formula specifies a range of 20-125
 mg for a 55 kg individual, that range would be adjusted for a 35 kg
 individual to 13-80 mg (e.g., the lower range limit=(35 kg/55 kg)*20
 mg=12.6 mg, or about 13 mg). Decimal amount may be rounded to the nearest
 whole number. In the above manner, the present compositions may be thus
 adapted to be suitable for any individual regardless of size.
 Further, the dosages may be adjusted to compensate for differences in
 physiological need, including without limitation differing physiological
 needs of women and men. Moreover, the formulations can be further adapted
 based upon the specific needs, genetic predispositions or identified
 deficiencies of the individual trying to conceive. Moreover, the present
 compositions can be used as one component of a prescribed therapy.
 The dosage forms of the present invention may involve the administration of
 a nutritional composition in a partial, i.e., fractional dose, one or more
 times during a 24 hour period, e.g., a single dose during a 24 hour period
 of time, or a multiple dose during a 24 hour period of time.
 The methods of the invention are applicable to males and females. The
 methods are also applicable to healthy and ill individuals, and are
 particularly suitable for individuals with heightened susceptibility to
 nausea and vomiting (e.g., pregnant woman, persons undergoing
 chemotherapy, etc.). The methods of the invention may be used alone or in
 combination with other therapies. For example, without limitation, the
 methods may involve the administration of the present compositions to
 pregnant women in combination with their prenatal vitamin regimen or may
 involve administration of the present compositions to post-operative
 patients along with pain medication. Thus, the methods would have
 prophylactic effect for individuals with higher susceptibility to nausea
 and/or vomiting. Additionally, the present invention may involve targeting
 specific time periods during which nausea can be most expected. By
 targeting specific time periods during which nausea or vomiting are most
 likely to occur with a drug delivery system, such as pulsed or delayed
 release, without limitation, relief from nausea or vomiting relief is
 unexpectedly higher than when targeted time delivery is not used.
 Further, in the previously stated preferred embodiments, the present
 invention may involve the application of a controlled amount of pressure
 to acupressure points, for example, without limitation, Neiguan
 acupressure points on both forearms of the patient. This may be achieved
 in various manners, for example, without limitation, by use of one or more
 pressure applying apparatuses, are adapted to be secured to the patient's
 arms, for example, without limitation, in the general manner of a watch
 band.
 Acupressure is a derivative technique of acupuncture, which is the Chinese
 method of pricking the body with needles at specific predetermined points
 or locations in order to relieve pain and/or cure disease. In acupressure,
 pressure is applied to the specific predetermined points or locations on
 the body, and no needles are used. One example of a specific predetermined
 point is the Neiguan point, which is located on the flexor side of the
 forearm just above the wrist. The Neiguan point is utilized in acupressure
 as a means of providing relief for nausea and vomiting.
 The present invention has numerous ancillary benefits, for example, without
 limitation, the present invention provides, in addition to relief from
 nausea or vomiting, the nutritional benefits inherent in vitamin and
 mineral supplementation. The present invention is also beneficial
 psychologically for individuals who anticipate nausea or vomiting in that
 it alleviates concern, relaxes and provides confidence to such
 individuals.

The constituents of the invention being thus described, the following
 represent examples of possible formulations and methods of manufacturing
 the present invention. The following examples are illustrative of
 preferred embodiments of the invention and are not to be construed as
 limiting the invention thereto.
 EXAMPLES
 Components of Anti-Nausea Compositions
 Example 1
 The following compositions are used to prepare anti-nausea products for
 administration to persons experiencing the symptoms of nausea.
 TABLE I
 CHEW- CON-
 ABLE TROLLED
 FORMULA FORMULA FOR- RE-
 COMPONENT I II MULA LEASE
 Vitamin B.sub.6, mg 20-50 75-125 50-75 75-125
 Folic Acid, mg -- 0.1-2 0.1-500 0.1-2
 Tablets incorporating the above formulations are prepared using
 conventional methods and materials known in the pharmaceutical art. The
 resulting nutritional conception composition tablets are recovered and
 stored for future use.
 Example II
 The following compositions are used to prepare anti-nausea products for
 administration to persons experiencing the symptoms of nausea.
 TABLE II
 CHEW- CON-
 FOR- FOR- ABLE TROLLED
 MULA MULA FOR- RE-
 COMPONENT I II MULA LEASE
 Vitamin B.sub.6, mg 20 125 50 125
 Vitamin B.sub.12, mg 12 12 12 12
 Folic Acid, mg -- 1 500 1
 Calcium Carbonate, mg 200 450 200 100
 Aluminum Hydroxide, -- -- -- 200
 mg
 Microcrystalline 200 200 -- 200
 Cellulose, mg
 Ethyl Cellulose -- -- -- 180
 Aqueous Dispersion,
 mg
 Croscarmellose 18 50 -- 18
 Sodium, mg
 Stearic Acid, mg 50 50 -- 50
 Magnesium Stearate, 10 10 15 10
 mg
 Opadry II, mg -- 45 -- 45
 Compressible Sugar, -- -- 700 --
 mg
 Flavor, mg -- -- 30 --
 Tablets incorporating the above formulations are prepared using
 conventional methods and materials known in the pharmaceutical art. The
 resulting nutritional composition tablets are recovered and stored for
 future use.
 Example III
 The following compositions are used to prepare nutritional anti-nausea
 products for administration to persons experiencing the symptoms of
 nausea. The components are adjusted based on the body weight of the
 individual.
 TABLE III
 PER 75 KG
 PER 35 KG OF PER 55 KG OF OF BODY
 COMPONENT BODY WEIGHT BODY WEIGHT WEIGHT
 Vitamin B.sub.6, mg 13-80 20-125 27-171
 Folic Acid, mg 0.06-1.3 0.1-2 0.14-2.7
 Tablets incorporating the above formulations are prepared using
 conventional methods and materials known in the pharmaceutical art. The
 resulting nutritional conception composition tablets are recovered and
 stored for future use.
 Example IV
 An antinausea and antiemetic formula, as described herein, may further be
 prepared, as follows:
 First, combine a compressible sugar with vitamin B.sub.6, and vitamin
 B.sub.12 in a blender, and blend until a uniform B vitamin and sugar
 mixture has been formed. Next, add color and calcium carbonate to the B
 vitamin and sugar mixture and blend until a uniform B vitamin and calcium
 carbonate mixture is formed. Then, to the B vitamin and calcium carbonate
 mixture add microcrystalline cellulose and croscarmellose sodium and mix
 well until a completely uniform B vitamin and cellulose mixture is
 reached. To the B vitamin and cellulose mixture add magnesium stearate and
 blend until a uniform, lubricated B vitamin and cellulose mixture is
 attained. The lubricated B vitamin and cellulose mixture is then
 compressed into a tablet using conventional methods. Then the resulting
 tablets are coated with stearic acid.
 Example V
 An antinausea and antiemetic formula, as described herein, may further be
 prepared, as follows:
 First, combine a compressible sugar with vitamin B.sub.6, vitamin B.sub.12
 and folic acid in a blender, and blend until a uniform B vitamin, folic
 acid and sugar mixture has been formed. Next, add color and calcium
 carbonate to the B vitamin, folic acid and sugar mixture. Blend until a
 uniform B vitamin, folic acid and calcium carbonate mixture is formed.
 Then, to the B vitamin, folic acid and calcium carbonate mixture add
 microcrystalline cellulose, croscarmellose sodium, and Opadry II and mix
 well until a completely uniform B vitamin, folic acid and cellulose
 mixture is reached. To the B vitamin, folic acid and cellulose mixture add
 magnesium stearate and blend until a uniform, lubricated mixture is
 attained. The lubricated mixture is then compressed into a tablet using
 conventional methods. Then the resulting tablets are coated with stearic
 acid.
 Example VI
 A chewable antinausea and antiemetic formula, as described herein, may
 further be prepared, as follows:
 First, combine a compressible sugar with vitamin B.sub.6, vitamin B.sub.12
 and folic acid in a blender, and blend until a uniform B vitamin, folic
 acid and sugar mixture has been formed. Next, add a flavor, color and
 calcium carbonate to the B vitamin, folic acid and sugar mixture. Blend
 until a uniform B vitamin, folic acid and calcium carbonate mixture is
 formed. Then, to the B vitamin, folic acid and calcium carbonate mixture
 add a compressible sugar and mix well until a completely uniform B
 vitamin, folic acid and compressible sugar mixture is reached. To the B
 vitamin, folic acid and compressible sugar mixture add magnesium stearate
 and blend until a uniform, lubricated mixture is attained. The lubricated
 mixture is then compressed into a tablet using conventional methods.
 Example VII
 A controlled release antinausea and antiemetic formula, as described
 herein, may further be prepared, as follows:
 First, combine a compressible sugar with vitamin B.sub.6, vitamin B.sub.12
 and folic acid in a blender, and blend until a uniform B vitamin, folic
 acid and sugar mixture has been formed. Next, add color and calcium
 carbonate to the B vitamin, folic acid and sugar mixture. Blend until a
 uniform B vitamin, folic acid and calcium carbonate mixture is formed.
 Then, to the B vitamin, folic acid and calcium carbonate mixture add
 aluminum hydroxide, microcrystalline cellulose, ethyl cellulose aqueous
 dispersion, croscarmellose sodium and Opadry II and mix well until a
 completely uniform B vitamin, folic acid and cellulose mixture is reached.
 To the B vitamin, folic acid and cellulose mixture add magnesium stearate
 and blend until a uniform, lubricated mixture is attained. The lubricated
 mixture is then compressed into a tablet using conventional methods. Then
 the resulting tablets are coated with stearic acid.
 The invention being thus described, it will be apparent that the same may
 be varied in many ways. Such variations are not to be regarded as a
 departure from the spirit and scope of the invention, and all such
 modifications are intended to be within the scope of the appended claims.