Abstract: A topical, transdermal anesthetic comprising a eutectic mixture of, preferably, lidocaine and prilocaine in a ratio of about 3:1 by weight, incorporated within a lipophilic base. In addition to the property of rapid-onset, the formulation of the present invention has high storage stability and is less restricted by dosage limitations of other prilocaine-containing transdermal anesthetics and is, advantageously, not dependent upon occlusive dressing for optimal transdermal absorption.

Abstract: An oral drug dosage unit, for administration to a patient, having active drug, and an effective diameter and surface composition sufficient for the unit to be transported from the stomach into the duodenum following substantially complete emptying of chyme from the stomach into the intestine and prior to release of active drug from the unit, wherein the active drug has an absorption rate that is substantially affected by the coinciding presence of food in the stomach, the effective diameter of the unit prevents gastric emptying of the unit prior to gastric emptying of chyme, and the surface composition is an enteric coating which prevents release of the active drug in the stomach and allows release of the active drug in the intestine.

Abstract: A process for making pharmaceutical dosage units containing a therapeutic quantity of one or more low dosage medicinal agent comprising granulating said medicinal agent in an aqueous medium which contains a pharmaceutically acceptable surfactant agent and, optionally, further processing the product of said granulating into a tablet or capsule dosage unit.

Abstract: Methods for preparing dry powders having hydrophobic and hydrophilic components comprise combining solutions or suspensions of the components and spray drying them simultaneously in a spray drier. The hydrophobic component may be dissolved in an organic solvent and the hydrophilic component suspended therein. The method provides dry powders having relatively uniform characteristics.

Abstract: The invention relates to a pharmaceutical formulation comprising diltiazem hydrochloride. The formulation is in the form of a mixture of beads blended so as to provide a dissolution profile that renders the formulation suitable for oral administration once daily.

Abstract: The present invention pertains to a sustained release drug delivery system hich comprises a core of active ingredient, an enteric coating, a second coating of active ingredient and lastly a readily gastric-soluble protective coating. The sustained release dosage form of this invention is useful for pharmaceutically active ingredients that have limited aqueous solubility, especially phenytoin sodium, and other pH dependent soluble drugs.

Abstract: The invention relates to a novel dosage unit for the sustained-release delivery of active agents as well as compositions and methods for making same.

Abstract: Direct compressed solid pharmaceutical dosage forms containing:a) from about 40 to about 95% by weight acetaminophen;b) from about 1 to about 60% by weight of a direct compression vehicle comprising microcrystalline cellulose; andc) from about 0.01 to about 4.0% by weight of a pharmaceutically-acceptable lubricant are disclosed. The acetaminophen and direct compression vehicle are combined under high shear conditions which are sufficient to transform acetaminophen and direct compression vehicle into a homogenous granulate without degradation. In preferred aspects of the invention, the lubricant is also combined with the acetaminophen and direct compression vehicle under high shear conditions. Methods of preparing the directly compressed solid pharmaceutical dosage forms and methods of treatment with the dosage forms are also disclosed. The methods are particularly well suited for preparing directly compressed dosage forms containing high load (i.e.

Abstract: A dietary supplement for animals, comprising safflower oil, sunflower oil, olive oil, soya oil, cod liver oil, lecithin, natural flavors, herbs, garlic, and zinc. When fed to a dog or cat daily in a proper dosage, the supplement reduces or eliminates non-seasonal shedding and promotes healthy skin and a glossy, silky coat, without affecting the dog's or cat's natural shedding cycle and without causing any harmful effects. The composition also may be administered topically.

Abstract: A recipient-dosage delivery system including shearlite particles of a bio-affecting agent for delivery to a recipient. The particles are provided in a metered dose and are packaged in a bi-functional vessel. The particles are produced under liquiflash conditions and exhibit sufficient flowability so as to allow administration of the metered dose to the recipient under the force of gravity.

Abstract: A method for making solid granules containing aromatic, nutritional, dietary or cosmetic substances, wherein a core consisting of excipients optionally combined with active substances is formed for use as a carrier, and the core is coated in three steps with at least one layer, with one layer being formed in each step, by (a) coating the core with active substances optionally combined with excipients, (b) drying the layer and (c) screening the coated core. The method is preferably used to make granules that contain plant extracts and essential oils and may be chewed, sucked, swallowed or dissolved.

Abstract: A chewable tablet comprises a medicament dispersed in a chewable base, such as mannitol, together with an effervescent couple, such as citric acid-sodium bicarbonate. The combination of effervescence and chewability with optional flavorings improves the taste characteristics of the medicament in oral administration. A disintegrant such as microcrystalline cellulose may be added to give the patient the option of dispersing the tablet in water.

Abstract: The present invention relates to compositions and methods for orally delivering antigens. The antigen and an adjuvant are combined with an acylated amino acid or polyamino acid and, a sulfonated amino acids or polyamino acid, or a salt of the foregoing.

Abstract: Methods of making tablets of a variety of physical forms are described. The tablets can be made into a wide variety of formulations. The invention further provides methods of making crystalline and amorphous anhydrous trehalose for use in formulating tablets suitable for use in dispensing pharmaceutical agents.

Abstract: A sustained release pharmaceutical formulation and methods of making and using the same are provided. The sustained release pharmaceutical formulation includes a sustained release excipient including a gelling agent, an inert pharmaceutical diluent, an optional hydrophobic material and/or hydrophobic coating, and a medicament for sustained oral administration.

Abstract: Modified amino acid compounds useful in the delivery of active agents are provided. Methods of administration and preparation are provided as well.

Abstract: The present invention concerns pharmaceutical compositions containing metformin as an active substance and a hydrocolloid-forming agent as a retardant and optionally standard pharmaceutical auxiliary substances, the residual moisture content in the pharmaceutical composition being 0.5-3% by weight. The invention also concerns a process for producing pharmaceutical compositions containing metformin as an active substance and a hydrocolloid-forming agent as a retardant and optionally standard pharmaceutical auxiliary substances characterized in that the active substance and retarding agent or a portion thereof are granulated with an aqueous solvent which can optionally contain a binder and where appropriate the other portion of the retardant or other standard pharmaceutical auxiliaries are admixed with the granulate which is then dried until the residual moisture content is reduced to 0.5-3% by weight.

Abstract: A capsule dosage form containing solid form of terazosin in a solid carrier is disclosed. The capsule dosage form is stable under accelerated stability conditions and therapeutically equivalent to known liquid-filled terazosin capsules.

Abstract: An oral solid dosage form, comprising a compressed tablet including an excipient comprising (a) microcrystalline cellulose; and (b) a compressibility augmenting agent which (I) physically restricts the proximity of the interface between adjacent cellulose surfaces (e.g., silicon dioxide); or (ii) inhibits interactions between adjacent cellulose surfaces (e.g., sodium lauryl sulfate); or (iii) accomplishes both (i) and (ii) above; together with an active agent, is disclosed which provides improved disintegration and/or absorptivity to the oral solid dosage form when orally administered to human patients. The excipient comprises agglomerated particles of said microcrystalline cellulose and said compressibility augmenting agent in intimate association with each other.

Abstract: The invention relates to sustained release formulations comprising 11-?4-?2-(2-hydroxyethoxy)ethyl!-1-piperazinyl!dibenzo?b,f! ?1,4!thiazepine or a pharmaceutically acceptable salt thereof, to methods of treating psychotic states and hyperactivity utilizing the sustained release formulations and to a process for preparing the sustained release formulations.