Disclosed is a synthetic, non-naturally occurring 12-amino acid peptide, Lung-specific Targeting Peptide, belonging to the larger class of cell penetrating peptides, for delivery of both diagnostic and potentially therapeutic agents to the lung. Also disclosed are methods of treating pulmonary disease, e.g., chronic obstructive pulmonary disease (COPD), emphysema, chronic bronchitis, asthma, primary ciliary dyskinesia (PCD), cystic fibrosis (CF), and lung cancer.

The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

The disclosure provides a novel polymorph of Compound (I):

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2-((1-(2-(4-Fluorophenyl)-2-oxoethyl)piperidin-4-yl)methyl)isoindolin-1-one monohydrochloride dihydrate, i.e., Form (A) of Compound (I)-HCl-2H.sub.2O. Pharmaceutical compositions comprising Form (A) of Compound (I)-HCl-2H.sub.2O and related methods of treatment are also disclosed.

The present disclosure provides extended release trihexyphenidyl compositions suitable for once- or twice-daily administration. The compositions comprise a core comprising at least one organic acid; at least one drug layer comprising trihexyphenidyl or a pharmaceutically acceptable salt thereof over the core; and a functional coat over the drug-layered core. The compositions of the disclosure provide extended release with reduced C.sub.max, a C.sub.min:C.sub.max ratio of ≥0.4, Fluctuation Index of ≤1, while providing and maintaining at least a minimum therapeutically effective plasma concentration, of the trihexyphenidyl or the pharmaceutically acceptable salt thereof for at least about 10 hours. The compositions of the disclosure improve solubility of the trihexyphenidyl or the pharmaceutically acceptable salt thereof at a pH of greater than or equal to 5, to provide and maintain at least a minimum effective concentration of the drug at such pH.

The invention pertains to a lipid-based microbubble stably binding a plurality of nucleic acids, and a method of delivering the microbubble and nucleic acids to a specific target site using ultrasound. The delivered nucleic acids create transgenic cells (i.e., for example, a transgenic tumor cell), wherein the transgenic cell expresses the proteins encoded by the delivered nucleic acids. This technology provides a significant improvement for microbubble-drug delivery platforms as known microbubble do not efficiently bind nucleic acids. The improvements described herein include but are not limited to identifying proper lipid proportionality ratios and/or cationic surfactant layers that provide an optimum mechanical index compatible with ultrasonics. Microbubble perfusion and/or nucleic acid delivery may be performed by a combination of imaging and ultrasound/microbubble targeted delivery to simultaneously perform low power two-dimensional imaging and high power microbubble destruction. Such systems are useful in therapeutics and/or diagnostics. For example, the data disclosed herein shows proof of principle in conjunction with the delivery of therapeutic siRNA molecules to slow tumor growth.

The invention relates to a hybrid proteinaceous molecule comprising at least two proteins capable of inhibiting the activity of at least one antibiotic, the proteins each having different biochemical properties and being bonded to one another. The hybrid proteinaceous molecule inhibits the activity of a least one antibiotic in order to reduce the intestinal side effects of antibiotics, such as severe diarrhoea caused by the antibiotics, and nosocomial infections secondary to parenteral antibiotic therapy.

Carvedilol parenteral sustained release systems by IV infusion, injection, or subcutaneous routes are disclosed. Preparation of carvedilol disperse systems such as liposomes, biodegradable microparticles or nanparticles, and polymeric microparticles or nanparticles have been presented in the present invention. Compositions containing carvedilol encapsulated in liposomes showed higher bioavailability and lower clearance rate than that of the free solution after intravenous administration. In vitro release of those liposomes in buffer solutions shows drug extended release over 48 hours, and correspondingly the in vivo animal data shows that parenteral administration of carvedilol encapsulated in liposomal materials has sustained release PK profile.

The invention concerns a pH-dependent gradual sustained release composition for increasing the pH in the upper part of the small intestines. Particles of the composition are provided with a multilayer polymer coating of specific structure which ensures the gradual release of the active agent in the range of pH 4.5 to 5.5. A process for preparing said composition is also claimed.

A water-insoluble composition, solid in appearance at a temperature of less than or equal to 20° C., comprising, for 100% of the mass of same:—X1% by mass of at least one lipophilic surfactant having a value HLB, H1, greater than or equal to 1 and less than 10;—X2% by mass of at least one hydrophilic surfactant having a value HLB, H2, greater than or equal to 10 and less than or equal to 20; characterised by the fact that the HLB of same=X1.H1+X2.H2, X1 and X2 varying from 2 to 60, and characterised in that it is free of acrylic polymer and/or of acetate succinate.

The present application relates to pharmaceutical compositions comprising retinoic acid or its derivatives such as isotretinoin and processes for preparing thereof. It also provides methods for treating acne by administering such pharmaceutical composition to a patient in need thereof.