The present disclosure relates to medical devices containing time-release drug substance, and more particularly, to medical tubing, catheters, stents, cables (including fiber optic cables), pills, capsules, sheaths, threads, clamps, sutures, and endotracheal devices. The invention also generally relates to a method for extruding multiple laminated flow streams using microlayer coextrusion to create these various time-release drug delivery products.

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 nanoparticles, and polymeric microparticles or nanoparticles 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 instant invention is generally directed to a patient-friendly drug delivery system for targeted populations, such as pediatric and geriatric patients. Specifically, the present invention relates to a pharmaceutical composition in the form of mini-tablets. Even more specifically, the present invention relates to a pharmaceutical composition comprising a therapeutically-effective amount of melatonin in the form of mini-tablets.

A patient-friendly drug delivery system and method for targeted populations, such as pediatric and geriatric patients is provided, which system and method include a pharmaceutical composition in the form of mini-tablets. A method of inducing and maintaining sleep in a human in need thereof with the mini-tablets is provided. A method of manufacturing mini-tablets is provided.

The present disclosure provides oral, chewable dosage forms that are suitable for delivery of one or more active ingredients to a consumer, particularly a human individual. The dosage forms can be configured as multicomponent compositions formed of: a first component including a gummy composition; a second component that is a particulate material or is a pre-formed solid unit or plurality of pre-formed solid units; and an active ingredient. The second component can be, for example, in the form of a pharmaceutically acceptable oral dosage unit, such as a tablet, a caplet, a soft shell capsule, a hard shell capsule, a microcapsule, or a pastille.

Drug delivery using bio-affecting drugs, particularly with shape changing drug delivery devices. Embodiments are included for depots for delivery of a therapeutic agent that change from an elongated state ex vivo to a coil in vivo where the agent is released.

The present subject matter is directed to pharmaceutical compositions comprising 3,5-diiodothyropropionic acid, or a salt thereof, and one or more pharmaceutically acceptable excipients. The present subject matter is further directed to methods of treating Allan-Herndon-Dudley syndrome comprising administering to a subject in need thereof one or more compositions comprising 3,5-diiodothyropropionic acid, or salt thereof, and one or more pharmaceutically acceptable excipients.

Provided herein are methods of treating a skeletal dysplasia such as hypochondroplasia or achondroplasia in a pediatric patient by administering to the patient infigratinib or a pharmaceutically acceptable salt thereof. Also provided are minitablets including infigratinib monophosphate and a pharmaceutically acceptable excipient for use in treating a skeletal dysplasia such as hypochondroplasia or achondroplasia in pediatric patients.

There is provide an extended release dosage form comprising a release modifying excipient comprising high amylose starch, cross-linked hydroxypropylated amylopectin, and a pre-gelatinized common starch; wherein the release modifying excipient is substantially free of crosslinks between amylose and amylopectin and substantially free of crosslinks between amylose and amylose. It has been found that the extended release properties of conventional cross-linked high amylose starches (e.g., Contramid) can be reproduced by intimately mixing i) cross-linked chemically modified amylopectin; ii) a high amylose, non-chemically modified starch and; iii) a pre-gelatinized common starch. Producing a release modifying excipient in this way means that no chemical cross linking between (a) amylose and amylopectin or (b) amylose and amylose has occurredproperties heretofore considered vital for Contramid function. The release modifying excipient blends overcome problems associated with use of Contramid, and provide a flexible platform for formulation of active pharmaceutical ingredients for controlled release applications.

An ingestible pill is provided that includes an enteric coating and a medication-delivery device, which includes (a) a patch having upper and lower surfaces that face in generally opposite directions, and (b) needles. The patch is disposed within the enteric coating, folded so as to define one or more creases, which define respective inner and outer crease sides, wherein at least 50% of the needles are coupled to the patch along the inner crease sides. The patch is configured to assume, after the enteric coating dissolves, an expanded shape, in which the patch has an outer perimeter. Other embodiments are also described.