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Updated: Jun 24, 2026
11:17
Comparative Analysis of Human Growth Hormone in Serum Using SPRi, Nano-SPRi and ELISA Assays
Published on: January 7, 2016
Development of a sustained-release recombinant human growth hormone formulation
1Biopharmaceutical Research Laboratory, Dong-A Pharm. Co. Ltd., Gyeonggi, 446-905, Republic of Korea.
Summary
A new sustained-release formulation of recombinant human growth hormone (rhGH) allows for weekly injections, improving treatment for short stature. This rhGH therapy shows sustained efficacy and safety in animal models.
Area of Science:
- Biotechnology
- Pharmacology
- Endocrinology
Background:
- Recombinant human growth hormone (rhGH) therapy for short stature requires daily injections due to poor bioavailability and short half-life.
- Developing a sustained-release formulation can improve patient compliance and treatment efficacy.
Purpose of the Study:
- To develop and evaluate a novel sustained-release formulation of rhGH (SR-rhGH), named DA-3003.
- To assess the pharmacokinetic, pharmacodynamic, safety, and efficacy profiles of DA-3003 in animal models.
Main Methods:
- DA-3003 was prepared using a double emulsion solvent evaporation technique with poly(D,L-lactide-co-glycolide) (PLGA), zinc oxide, and hydroxypropyl-beta-cyclodextrin (HPCD).
- Pharmacokinetic studies involved single administrations in rats and monkeys, measuring plasma rhGH levels.
- Pharmacodynamic markers (IGF-I, IGFBP-3), antibody development, and efficacy (body weight, tibial growth plate width) were assessed in monkeys and hypophysectomized rats.
Main Results:
- A single administration of DA-3003 sustained rhGH plasma concentrations for 14 days in rats and 28 days in monkeys.
- Pharmacodynamic markers (IGF-I, IGFBP-3) remained elevated for approximately 28 days in monkeys.
- DA-3003 showed comparable efficacy to daily rhGH injections in hypophysectomized rats and did not induce antibody formation in monkeys.
Conclusions:
- The sustained-release rhGH formulation DA-3003 demonstrates potential for safe and effective weekly administration.
- This novel formulation could offer a significant improvement over daily rhGH injection regimens for treating short stature.
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