Abstract
Growth hormone treatment has many indications including the treatment of growth hormone deficiency, Prader–Willi syndrome, chronic renal insufficiency, Turner syndrome, AIDS-related wasting, idiopathic short stature in children, and accumulation of fat which related in adults with lipodystrophy. Conventional therapy was achieved using intramuscular and subcutaneous injections. However, noncompliance was very high. To solve this; many studies have been attempted to prepare long-acting formulations and new to make derivatives of growth hormone and to use alternative routes of administration which term as noninvasive routes such as intranasal, pulmonary, transdermal and oral. New delivery systems were also used such as needle-free and auto-injector devices. In this review, different formulations, technologies, and routes of growth hormone delivery will be presented with the discussion of the principles of formulations and selected additives that were used to achieve improved growth hormone formulations.
Highlights
Growth hormone (GH), which called somatotropin, is a singlechain polypeptide
The nutropin depot® is the first sustained release microsphere formulation of recombinant human growth hormone (rhGH) based on PLGA (FDA approved in December 1999)
APLGA is a biocompatible and biodegradable copolymer that most repeatedly aimed in the controlled release of drugs b nutropin depot® is the first sustained release microsphere formulation of rhGH based on PLGA (FDA approved in December 1999). c PELA microspheres provided a stable microenvironment since the amphiphilic PELA blocks the contact of protein with the oil/water interface, so it enhances retention of the protein drug. d Hyaluronic acid (HA) is a natural biocompatible and biodegradable material that is often used as a matrix in microparticle formulations
Summary
Growth hormone (GH), which called somatotropin, is a singlechain polypeptide. GH stimulates the growth, cell reproduction, and regeneration in humans and in animals. Several GH formulations were examined in humans or experimental animals including microspheres, benzyl benzoate/poly-D, L-lactic-co-glycolic acid PLGA depot solution, PEGylated GH, prodrugs, fusion with other proteins, hydrogels, and PLGA implants. These formulations are discussed here based on the additives used to formulate them. When microspheres have to be injected, the injection steps may be more painful because of both a larger needle size and a larger volume have to be administered to achieve extended effect [16] This approach was based on changing the solvent by the addition of nonsolvent to it.
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