In vivo characterization of sustained-release formulations of human growth hormone.

Lee HJ, Riley G, Johnson O, Cleland JL, Kim N, Charnis M, Bailey L, Duenas E, Shahzamani A, Marian M, Jones AJ, Putney SD

The Journal of pharmacology and experimental therapeutics1 Jun 1997Cited by 52 (Europe PMC)

PMID9190880DOI10.1016/s0022-3565(24)36732-1PepBankPUB-09190880

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study12

7 results from studies that gave the peptide. No result from this study comes from people.

01AnimalAnimal study (in vivo)Pharmacokinetics
In rhesus monkeys, all rhGH microsphere formulations sustained elevated serum rhGH for several weeks.
In plain wordsIn rhesus monkeys, all rhGH microsphere formulations maintained elevated blood rhGH for several weeks.
Peptide
HGH (somatotropin)
Outcome
IncreaseSustained serum rhGH
Study
rhesus monkeyn: not reported in source
juvenile rhesus monkeys
Outcome group
Pharmacokinetics · Endocrine and hormones
Studied dose
Dose not stated · subcutaneousAs given in this study (rhesus monkey).
Source sentences
Summary
All three formulations, which differed principally in the composition of the polymer, provided sustained elevated levels of all three proteins for several weeks, and the rate of release of rhGH differed among the formulations consistent with the molecular weight of the polymer used.
1 context sentence(design, population, supporting numbers)
Summary · context
The formulations were compared in juvenile rhesus monkeys by measuring the serum levels of rhGH and two proteins induced by hGH, insulin-like growth factor-I and IGF binding protein-3 (IGFBP-3) after single s.c. administration.
Report a problemFND-0919088001
02AnimalAnimal study (in vivo)Efficacy outcome
In rhesus monkeys, all rhGH microsphere formulations sustained elevated serum IGF-I for several weeks.
In plain wordsIn rhesus monkeys, all rhGH microsphere formulations maintained elevated blood IGF-I for several weeks.
Peptide
HGH (somatotropin)
Outcome
IncreaseSustained serum IGF-I
Study
rhesus monkeyn: not reported in source
juvenile rhesus monkeys
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated · subcutaneousAs given in this study (rhesus monkey).
Source sentences
Summary
All three formulations, which differed principally in the composition of the polymer, provided sustained elevated levels of all three proteins for several weeks, and the rate of release of rhGH differed among the formulations consistent with the molecular weight of the polymer used.
1 context sentence(design, population, supporting numbers)
Summary · context
The formulations were compared in juvenile rhesus monkeys by measuring the serum levels of rhGH and two proteins induced by hGH, insulin-like growth factor-I and IGF binding protein-3 (IGFBP-3) after single s.c. administration.
Report a problemFND-0919088002
03AnimalAnimal study (in vivo)Efficacy outcome
In rhesus monkeys, all rhGH microsphere formulations sustained elevated serum IGFBP-3 for several weeks.
In plain wordsIn rhesus monkeys, all rhGH microsphere formulations maintained elevated blood IGFBP-3 for several weeks.
Peptide
HGH (somatotropin)
Outcome
IncreaseSustained serum IGFBP-3
Study
rhesus monkeyn: not reported in source
juvenile rhesus monkeys
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated · subcutaneousAs given in this study (rhesus monkey).
Source sentences
Summary
All three formulations, which differed principally in the composition of the polymer, provided sustained elevated levels of all three proteins for several weeks, and the rate of release of rhGH differed among the formulations consistent with the molecular weight of the polymer used.
1 context sentence(design, population, supporting numbers)
Summary · context
The formulations were compared in juvenile rhesus monkeys by measuring the serum levels of rhGH and two proteins induced by hGH, insulin-like growth factor-I and IGF binding protein-3 (IGFBP-3) after single s.c. administration.
Report a problemFND-0919088003
04AnimalAnimal study (in vivo)Pharmacokinetics
In rhesus monkeys, rhGH remained elevated for nearly 90 days after three monthly injections of rhGH-loaded microspheres.
In plain wordsIn rhesus monkeys, rhGH remained elevated for nearly 90 days after three monthly injections of rhGH-loaded microspheres.
Peptide
HGH (somatotropin)
Outcome
IncreaserhGH after repeated microsphere injections
Study
rhesus monkeyn: not reported in source
juvenile rhesus monkeys
Outcome group
Pharmacokinetics · Endocrine and hormones
Studied dose
Dose not stated · subcutaneousAs given in this study (rhesus monkey).
Source sentences
Summary
After three monthly injections of one of the formulations, both the rhGH and IGF-I levels remained elevated for nearly 90 days.
1 context sentence(design, population, supporting numbers)
Summary · context
The formulations were compared in juvenile rhesus monkeys by measuring the serum levels of rhGH and two proteins induced by hGH, insulin-like growth factor-I and IGF binding protein-3 (IGFBP-3) after single s.c. administration.
Report a problemFND-0919088007
05AnimalAnimal study (in vivo)Efficacy outcome
In rhesus monkeys, IGF-I remained elevated for nearly 90 days after three monthly rhGH microsphere injections.
In plain wordsIn rhesus monkeys, IGF-I remained elevated for nearly 90 days after three monthly rhGH microsphere injections.
Peptide
HGH (somatotropin)
Outcome
IncreaseIGF-I after repeated microsphere injections
Study
rhesus monkeyn: not reported in source
juvenile rhesus monkeys
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated · subcutaneousAs given in this study (rhesus monkey).
Source sentences
Summary
After three monthly injections of one of the formulations, both the rhGH and IGF-I levels remained elevated for nearly 90 days.
1 context sentence(design, population, supporting numbers)
Summary · context
The formulations were compared in juvenile rhesus monkeys by measuring the serum levels of rhGH and two proteins induced by hGH, insulin-like growth factor-I and IGF binding protein-3 (IGFBP-3) after single s.c. administration.
Report a problemFND-0919088008
06AnimalAnimal study (in vivo)Safety outcome
In rhesus monkeys, rhGH microsphere injection sites appeared macroscopically normal between 1 to 2 mo after administration.
In plain wordsIn rhesus monkeys, rhGH microsphere injection sites appeared normal on visual examination between 1 to 2 mo after injection.
Peptide
HGH (somatotropin)
Outcome
Not applicableMacroscopic injection-site appearance
Study
rhesus monkeyn: not reported in source
juvenile rhesus monkeys
Outcome group
Adverse events · Skin and wound
Studied dose
Dose not stated · subcutaneousAs given in this study (rhesus monkey).
Source sentences
Summary
In addition, the microsphere injection sites appeared normal by macroscopic evaluation between 1 to 2 mo after microsphere administration and by microscopic evaluation between 2 to 3 mo.
1 context sentence(design, population, supporting numbers)
Summary · context
The formulations were compared in juvenile rhesus monkeys by measuring the serum levels of rhGH and two proteins induced by hGH, insulin-like growth factor-I and IGF binding protein-3 (IGFBP-3) after single s.c. administration.
Report a problemFND-0919088011
07AnimalAnimal study (in vivo)Safety outcome
In rhesus monkeys, rhGH microsphere injection sites appeared microscopically normal between 2 to 3 mo after administration.
In plain wordsIn rhesus monkeys, rhGH microsphere injection sites appeared normal under a microscope between 2 to 3 mo after injection.
Peptide
HGH (somatotropin)
Outcome
Not applicableMicroscopic injection-site appearance
Study
rhesus monkeyn: not reported in source
juvenile rhesus monkeys
Outcome group
Adverse events · Skin and wound
Studied dose
Dose not stated · subcutaneousAs given in this study (rhesus monkey).
Source sentences
Summary
In addition, the microsphere injection sites appeared normal by macroscopic evaluation between 1 to 2 mo after microsphere administration and by microscopic evaluation between 2 to 3 mo.
1 context sentence(design, population, supporting numbers)
Summary · context
The formulations were compared in juvenile rhesus monkeys by measuring the serum levels of rhGH and two proteins induced by hGH, insulin-like growth factor-I and IGF binding protein-3 (IGFBP-3) after single s.c. administration.
Report a problemFND-0919088012

Studies that did not test the peptide alone5

In this study, HGH (somatotropin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking HGH (somatotropin).

08AnimalNot a test of HGH (somatotropin) aloneAnimal study (in vivo)Pharmacokinetics
In rhesus monkeys, release rates from rhGH-loaded microspheres differed with polymer molecular weight.
In plain wordsIn rhesus monkeys, release rates from rhGH-loaded microspheres differed with polymer molecular weight.
Peptide
HGH (somatotropin)
Outcome
MixedFormulation-dependent rhGH release
Study
rhesus monkeyn: not reported in source
juvenile rhesus monkeys
Comparator
Other microsphere formulations
Outcome group
Pharmacokinetics · Endocrine and hormones
Source sentences
Summary
All three formulations, which differed principally in the composition of the polymer, provided sustained elevated levels of all three proteins for several weeks, and the rate of release of rhGH differed among the formulations consistent with the molecular weight of the polymer used.
1 context sentence(design, population, supporting numbers)
Summary · context
The formulations were compared in juvenile rhesus monkeys by measuring the serum levels of rhGH and two proteins induced by hGH, insulin-like growth factor-I and IGF binding protein-3 (IGFBP-3) after single s.c. administration.
In this study, HGH (somatotropin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking HGH (somatotropin).
Report a problemFND-0919088004
09AnimalNot a test of HGH (somatotropin) aloneAnimal study (in vivo)Efficacy outcome
In rhesus monkeys, all rhGH microsphere formulations induced higher IGF-I than daily injections of the same amount of rhGH solution.
In plain wordsIn rhesus monkeys, rhGH microspheres produced higher IGF-I than daily injections of the same amount of rhGH solution.
Peptide
HGH (somatotropin)
Outcome
IncreaseIGF-I versus daily rhGH solution
Study
rhesus monkeyn: not reported in source
juvenile rhesus monkeys
Comparator
Daily injections of the same amount of rhGH in solution
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Source sentences
Summary
All three formulations induced a higher level of insulin-like growth factor-I and insulin-like growth factor binding protein than was induced by daily injections of the same amount of rhGH in solution.
1 context sentence(design, population, supporting numbers)
Summary · context
The formulations were compared in juvenile rhesus monkeys by measuring the serum levels of rhGH and two proteins induced by hGH, insulin-like growth factor-I and IGF binding protein-3 (IGFBP-3) after single s.c. administration.
In this study, HGH (somatotropin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking HGH (somatotropin).
Report a problemFND-0919088005
10AnimalNot a test of HGH (somatotropin) aloneAnimal study (in vivo)Efficacy outcome
In rhesus monkeys, all rhGH microsphere formulations induced higher IGF binding protein than daily injections of the same amount of rhGH solution.
In plain wordsIn rhesus monkeys, rhGH microspheres produced higher IGF binding protein than daily injections of the same amount of rhGH solution.
Peptide
HGH (somatotropin)
Outcome
IncreaseIGF binding protein versus daily rhGH solution
Study
rhesus monkeyn: not reported in source
juvenile rhesus monkeys
Comparator
Daily injections of the same amount of rhGH in solution
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Source sentences
Summary
All three formulations induced a higher level of insulin-like growth factor-I and insulin-like growth factor binding protein than was induced by daily injections of the same amount of rhGH in solution.
1 context sentence(design, population, supporting numbers)
Summary · context
The formulations were compared in juvenile rhesus monkeys by measuring the serum levels of rhGH and two proteins induced by hGH, insulin-like growth factor-I and IGF binding protein-3 (IGFBP-3) after single s.c. administration.
In this study, HGH (somatotropin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking HGH (somatotropin).
Report a problemFND-0919088006
11AnimalNot a test of HGH (somatotropin) aloneAnimal study (in vivo)Safety outcome
In rhesus monkeys and rhGH-expressing transgenic mice, microsphere rhGH did not increase seroconversion incidence compared with unencapsulated rhGH.
In plain wordsIn rhesus monkeys and transgenic mice, rhGH microspheres did not increase seroconversion compared with unencapsulated rhGH.
Peptide
HGH (somatotropin)
Outcome
Direction not reportedSeroconversion to hGH
Study
rhesus monkeys and micen: not reported in source
rhesus monkeys and transgenic mice expressing rhGH
Comparator
Unencapsulated rhGH
Outcome group
Immune response · Immune and inflammation
Source sentences
Summary
Immunogenicity of the rhGH released from this formulation, as assessed by the incidence of seroconversion to hGH and the titer of anti-hGH antibody in both the rhesus monkeys and transgenic mice expressing rhGH, was no greater than that of the unencapsulated protein.
1 context sentence(design, population, supporting numbers)
Summary · context
The formulations were compared in juvenile rhesus monkeys by measuring the serum levels of rhGH and two proteins induced by hGH, insulin-like growth factor-I and IGF binding protein-3 (IGFBP-3) after single s.c. administration.
In this study, HGH (somatotropin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking HGH (somatotropin).
Report a problemFND-0919088009
12AnimalNot a test of HGH (somatotropin) aloneAnimal study (in vivo)Safety outcome
In rhesus monkeys and rhGH-expressing transgenic mice, microsphere rhGH did not increase anti-hGH antibody titers compared with unencapsulated rhGH.
In plain wordsIn rhesus monkeys and transgenic mice, rhGH microspheres did not increase antibody titers compared with unencapsulated rhGH.
Peptide
HGH (somatotropin)
Outcome
Direction not reportedAnti-hGH antibody titer
Study
rhesus monkeys and micen: not reported in source
rhesus monkeys and transgenic mice expressing rhGH
Comparator
Unencapsulated rhGH
Outcome group
Immune response · Immune and inflammation
Source sentences
Summary
Immunogenicity of the rhGH released from this formulation, as assessed by the incidence of seroconversion to hGH and the titer of anti-hGH antibody in both the rhesus monkeys and transgenic mice expressing rhGH, was no greater than that of the unencapsulated protein.
1 context sentence(design, population, supporting numbers)
Summary · context
The formulations were compared in juvenile rhesus monkeys by measuring the serum levels of rhGH and two proteins induced by hGH, insulin-like growth factor-I and IGF binding protein-3 (IGFBP-3) after single s.c. administration.
In this study, HGH (somatotropin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking HGH (somatotropin).
Report a problemFND-0919088010

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

Journal Article

MeSH terms

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