Abstract: A biodegradable, multi-layered controlled release gastroretentive baclofen or R-baclofen dosage form which is optionally divided into a first dosage of baclofen or R-baclofen for immediate release and a second dosage of baclofen or R-baclofen for controlled release in the stomach and gastrointestinal tract of a patient, folded into a capsule which disintegrates upon contact with gastric juice and the dosage form unfolds rapidly upon contact with gastric juice. The biodegradable, multi-layered gastroretentive dosage forms of the invention provide fast onset of baclofen or R-baclofen activity with prolonged absorption and minimal undesirable side effects.

Abstract: The present invention provides a gastro-retentive delivery assembly (GRDA) comprising a folded multi-layered device comprising a macromolecule-containing compartment bordered by enveloping layers and one or more enforcing strips, the device being adapted to unfold when in a subject's stomach, whereupon unfolding, the macromolecule is released from said device via at least one aperture in an enveloping layer. The invention also provides a method for gastroretentive delivery of macromolecules via the GRDA of the invention; a method of preparing the GRDA of the invention as well as a method for treating a subject for a pathological condition, making use of the GRDA of the invention.