Abstract: This invention relates to coated digestive enzyme preparations and enzyme delivery systems and pharmaceutical compositions comprising the preparations. This invention further relates to methods of preparation and use of the systems, pharmaceutical compositions and preparations to treat persons having ADD, ADHD, autism, cystic fibrosis and other behavioral and neurological disorders.

Abstract: Described herein are compositions which include digestive enzymes and which are formulated to reduce one or more symptoms of Celiac disease. Also described herein is a method for treating a subject with Celiac disease using digestive enzymes and their derivatives to alleviate the symptoms of Celiac disease. The method comprises administering to the individual an effective amount of digestive enzymes that are either naturally or recombinantly derived, or their derivatives, in an amount effective to reduce one or more symptoms of Celiac disease.

Abstract: Described herein are compositions which include digestive enzymes and which are formulated to reduce one or more symptoms of Celiac Disease. Also described herein is a method for treating a subject with Celiac Disease using digestive enzymes and their derivatives to alleviate the symptoms of Celiac Disease. The method comprises administering to the individual an effective amount of digestive enzymes that are either naturally or recombinantly derived, or their derivatives, in an amount effective to reduce one or more symptoms of Celiac Disease.

Abstract: Compositions and methods of using the compositions for wound healing are provided. The compositions include one or more digestive enzymes, for example, one or more protease, lipases, and amylases. The compositions can be formulated as topical pharmaceutical compositions and can be used for faster healing through stimulation of epidermal cells in the absence of scarring. The compositions may deposit a short-term fibrosis and help prevent re-opening of wounds. The compositions may improve recruitment of white blood cells, thereby inducing or enhancing growth factor and immune system activation via an enzyme antibiotic effect. The compositions may enhance the epidermal integrity beyond that of the normal physiological restorative process. Application of the compositions may result in greater re-growth of hair on regions of wounds healed with enzyme and reduced alopecia. The compositions may be administered without causing allergic reactions and without causing biological damage or burns.

Abstract: Disclosed herein are methods of using coated digestive enzyme preparations and enzyme delivery systems and pharmaceutical compositions comprising the preparations for treatment of subjects having behavioral disorders, neurological disorders or mental health disorders. Disclosed herein are methods of treating core and non-core symptoms of behavioral disorders, neurological disorders or mental health disorders. Also disclosed herein are products for use in methods of treatment and methods of making the same.

Abstract: This disclosure relates to early diagnosis and assessment tools for Parkinson's disease, movement disorder, neurological disease, and/or chronic pain, designed to drive innovation and to accelerate best Parkinson's disease, movement disorders, neurological disease, and chronic pain research. The present disclosure facilitates improved access to Parkinson's disease, movement disorders, neurological disease, and chronic pain patients along with innovative data capture methods that are designed to leading to improved therapies and assisting in finding a cure for Parkinson's disease, movement disorders, neurological diseases, and/or chronic pain. In addition the present disclosure is broadly applicable as a diagnosis and assessment tool to all movement disorders and many neurological diseases and/or chronic pain.

Abstract: A pharmaceutical composition for use in the treatment of the symptoms of an addiction is disclosed. The pharmaceutical composition contains, but is not limited to, digestive enzymes. The pharmaceutical composition may further contain a coating that surrounds a core of digestive enzymes in the form of coated particles. The pharmaceutical composition may also be encapsulated. The therapeutic agent may be manufactured by a variety of technologies.

Abstract: Described herein are compositions which include digestive enzymes and which are formulated to reduce one or more symptoms of Celiac Disease or a related disorder. Also described herein is a method for treating a subject with Celiac Disease or a related disorder using digestive enzymes and their derivatives to alleviate the symptoms of Celiac Disease or a related disorder. The method comprises administering to the individual an effective amount of digestive enzymes that are either naturally or recombinantly derived, or their derivatives, in an amount effective to reduce one or more symptoms of Celiac Disease or a related disorder.

Abstract: A method to treat Influenza, and more particularly Influenza A Virus Subtype H1N1, with the use of a pharmaceutical composition comprising one or more digestive enzymes, such as pancreatic enzymes and porcine pancreatic enzymes, is disclosed. The method includes the use of an individual's fecal chymotrypsin level as an indicator e.g., biomarker of whether an individual may be more susceptible to Influenza, e.g., Influenza A Subtype H1N1, and/or whether an individual will benefit from administration of the described pharmaceutical compositions. Use of the compositions as sanitizers, antiseptics, disinfectants, and detergents, e.g., to reduce or eradicate influenza virus present on living or inanimate surfaces is also contemplated.

Abstract: Described herein are compositions which include digestive enzymes and which are formulated to reduce one or more symptoms of celiac disease or a related disorder. Also described herein is a method for treating a subject with celiac disease or a related disorder using digestive enzymes and their derivatives to alleviate the symptoms of celiac disease or a related disorder. The method comprises administering to the individual an effective amount of digestive enzymes that are either naturally or recombinantly derived, or their derivatives, in an amount effective to reduce one or more symptoms of celiac disease or a related disorder.

Abstract: This disclosure relates to the prevention and treatment of Influenza, and more particularly Influenza A Virus Subtype H1N1, with the use of a pharmaceutical composition comprising one or more digestive enzymes, such as pancreatic enzymes and porcine pancreatic enzymes. The disclosure further relates to the use of an individual's fecal chymotrypsin level as an indicator e.g., biomarker of whether an individual may be more susceptible to Influenza, e.g., Influenza A Subtype H1N1, and/or whether an individual will benefit from administration of the described pharmaceutical compositions. Use of the compositions as sanitizers, antiseptics, disinfectants, and detergents, e.g., to reduce or eradicate influenza virus present on living or inanimate surfaces is also contemplated.

Abstract: Formulations have been developed administering methscopolamine in multi-phases. In a preferred embodiment, the formulation contains methscopolamine in an immediate release. (“IR”) form and a sustained or delayed release (“DR”) form and/or poised release (“PR”) form. In another embodiment, the methscopolamine is released in a gradient, decreasing the side effects associated with rapidly elevated blood levels. In another embodiment the drug is bound to an ion-exchange resin, which can be suspended in a liquid or incorporated into a matrix for delayed, sustained and/or pulsed release. Dosage unit forms may be tablets, gels, liquids, capsules, beads, microparticles, films or lozenges. Multi-phase delivery can also be achieved through the use of a kit that provides for dosage escalation. This kit can be a blister pack or equivalent, wherein the drug is packaged so that a first dosage is taken, then sequentially larger dosages.

Abstract: Formulations have been developed administering a guaiacolsulfonate salt, preferably potassium salt, in multi-phases. In a preferred embodiment, the formulation contains potassium guaiacolsulfonate in an immediate release (“IR”) form and a sustained or delayed release (“DR”) form and/or pulsed release (“PR”) form. In another embodiment, the potassium guaiacolsulfonate is released in a gradient, decreasing the side effects associated with rapidly elevated blood levels. In another embodiment, the drug is bound to an ion-exchange resin, which can be suspended in a liquid or incorporated into a matrix for delayed, sustained and/or pulsed release. Dosage unit forms may be tablets, gels, liquids, capsules, beads, microparticles, films or lozenges. Multi-phase delivery can also be achieved through the use of a kit that provides for dosage escalation. The formulations are useful in the treatment of one or more symptoms of coughs, colds, sinusitis and other respiratory illnesses.

Abstract: Formulations have been developed administering a guaiacolsulfonate salt, preferably potassium salt, in multi-phases. In a preferred embodiment, the formulation contains potassium guaiacolsulfonate in an immediate release (“IR”) form and a sustained or delayed release (“DR”) form and/or pulsed release (“PR”) form. In another embodiment, the potassium guaiacolsulfonate is released in a gradient, decreasing the side effects associated with rapidly elevated blood levels. In another embodiment, the drug is bound to an ion-exchange resin, which can be suspended in a liquid or incorporated into a matrix for delayed, sustained and/or pulsed release. Dosage unit forms may be tablets, gels, liquids, capsules, beads, microparticles, films or lozenges. Multi-phase delivery can also be achieved through the use of a kit that provides for dosage escalation. The formulations are useful in the treatment of one or more symptoms of coughs, colds, sinusitis and other respiratory illnesses.

Abstract: Formulations have been developed administering methscopolamine in multi-phases. In a preferred embodiment, the formulation contains methscopolamine in an immediate release. (“IR”) form and a sustained or delayed release (“DR”) form and/or poised release (“PR”) form. In another embodiment, the methscopolamine is released in a gradient, decreasing the side effects associated with rapidly elevated blood levels. In another embodiment the drug is bound to an ion-exchange resin, which can be suspended in a liquid or incorporated into a matrix for delayed, sustained and/or pulsed release. Dosage unit forms may be tablets, gels, liquids, capsules, beads, microparticles, films or lozenges. Multi-phase delivery can also be achieved through the use of a kit that provides for dosage escalation. This kit can be a blister pack or equivalent, wherein the drug is packaged so that a first dosage is taken, then sequentially larger dosages.

Abstract: A mixed-release tablet or capsule formulation including vehicles for the delivery of a plurality of drugs in various combinations of immediate release, extended release, and/or delayed release modes over a predetermined time period have been developed, which provide for controlled release not just of the drugs, but controlled release that is designed to create more effective coordination between the drugs being delivered. The drugs can be any medically and/or physiologically appropriate combination of drugs and active ingredients, preferably decongestant drugs, antihistamines, expectorants, antitussives, cough suppressants, and drying agents.