Atlantic Pharmaceuticals, Inc.

Other

The University of Tennessee Research Foundation

Atul J Shukla

James R Johnson

Yichun Sun

Yingxu Peng

Anthony Edward Soscia

Robert Cooper

Gregg Boring

Dan Scruggs

A dosage form from which a burst release of a drug contained within a tampered dosage form is reduced or retarded by the presence in or on the dosage form of a TPTA (Tamper Prone Therapeutic Agent) trap. If the dosage form has not been tampered with, the TPTA trap does not significantly interfere with the rate of release of the drug from the dosage form. However, if the dosage form has been physically tampered with, the TPTA trap reduces or retards burst release of the drug from the dosage form.

Dosage forms for tamper prone therapeutic agents

A formulation containing one or more biologically active substances dissolved, dispersed, emulsified, or suspended within a vehicle of one or more citric acid esters and/or citric acid ethers. Methods for making and using are disclosed, as are kits for administration of the pharmaceutical formulation.

Vehicles for delivery of biologically active substances

A biodegradable vehicle and filler (referred to in this invention as biodegradable vehicle), which can be mixed with one or more biologically active substances (BAS), or can be used as a biodegradable filler to fill in cavities or body tissues in animals, birds and humans. The consistency and rheology, hydrophilicity and hydrophobicity, and in vivo degradation rates of the biodegradable vehicle is controlled by modulating the molecular weight of polymers and copolymers, concentration of plasticizers, ratios of two or more plasticizer in the blends, types of polymers and copolymers, copolymer ratios, and ratios of blends of polymers with different molecular weights or different copolymers. The biodegradable vehicle is mixed with one or more BAS (which is separately stored away from the biodegradable vehicle in an appropriate container) just prior to use. Mixing of the BAS with the biodegradable vehicle can be accomplished by simply stirring the mixture with a stirring device, or by triturating the mixture or employing an ointment mill or a suitable device or apparatus or equipment that can be used for blending/mixing. Alternatively, a device, which resembles two syringes, attached together with a removable partition or a valve assembly can also be used to uniformly mix the BAS with the biodegradable vehicle. The mixing is performed in order to dissolve or uniformly suspend the BAS particles in the biodegradable vehicle. Modulating the polymer to plasticizer ratio, polymer molecular weight, copolymer ratio, and hydrophobicity and hydrophilicity of the plasticizer controls the release of the BAS from the biodegradable vehicle.

Biodegradable vehicle and filler

Biodegradable delivery systems of physiologically, pharmacologically and biologically active substance(s) (BAS) are provided. These systems are obtained by incorporating the BAS into a blend of biodegradable polymers and plasticizers using a novel solvent evaporation method. This method involves dissolving the biodegradable polymer or copolymer and a plasticizer into a volatile solvent. The BAS may then be added to this mixture. The volatile solvent is removed using vacuum or at an elevated temperature or using a combination of both vacuum and elevated temperature. The resultant mixture is a BAS-loaded formulation which when injected, implanted or applied in vivo in an animal or human, provides controlled release of the BAS over the desired period of time. Alternatively, a blank formulation may be first prepared by the aforementioned methodology without incorporating the BAS in the formulation. An appropriate quantity of BAS is then added to this formulation to yield a BAS-loaded formulation which may control the release of the BAS for the desired length of time.

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Cordova, TN, United States of America

Atul J Shukla