The Impact of Drying Method and Formulation on the Physical Properties and Stability of Methionyl Human Growth Hormone in the Amorphous Solid State

2008 ◽  
Vol 97 (1) ◽  
pp. 163-184 ◽  
Author(s):  
Ahmad M. Abdul‐Fattah ◽  
David Lechuga‐Ballesteros ◽  
Devendra S. Kalonia ◽  
Michael J. Pikal
1987 ◽  
Vol 253 (5) ◽  
pp. E508-E514
Author(s):  
J. Weiss ◽  
M. J. Cronin ◽  
M. O. Thorner

Growth hormone (GH) is secreted as pulses in vivo. To understand the signals governing this periodicity, we have established a perifusion-based model of pulsatile GH release. Male rat anterior pituitaries were dispersed and perifused with pulses of human growth hormone-releasing factor-(1--40) (GHRF), with or without a continuous or discontinuous somatostatin tonus. An experiment was composed of a 1-h base-line collection followed by four 3-h cycles; each contained single or paired 10-min infusion(s) of 3 nM GHRF. In testing the impact of somatostatin, the protocol was identical except that 0.3 nM somatostatin was added 30 min into the base-line period and then was either continued throughout the study or withdrawn during the periods of GHRF infusion. GH base lines with somatostatin were lower than vehicle base lines (P less than 0.05). GHRF pulses generated consistent peaks of GH release between 200 and 300 ng. min-1. (10(7) cells)-1, and these peaks were not altered by continuous somatostatin. In contrast, withdrawal of somatostatin during GHRF administration elicited markedly higher GH peaks (P less than 0.05) and more total GH release (P less than 0.05). This response could not be accounted for by the additive effects of GHRF and somatostatin withdrawal.


2018 ◽  
Vol 90 (2) ◽  
pp. 128-131 ◽  
Author(s):  
Mabrouka A. Altowati ◽  
Sheila Shepherd ◽  
Paraic McGrogan ◽  
Richard K. Russell ◽  
S. Faisal Ahmed ◽  
...  

Background/Aims: There is limited information on the impact of recombinant human growth hormone (rhGH) on the muscle-bone unit in children with Crohn’s disease (CD). In this pilot study, we report on the effects of rhGH on bone formation, dual-energy X-ray absorptiometry (DXA) total body (TB) bone mineral density adjusted for height and lumbar spine (LS) bone mineral apparent density (BMAD), and body composition. Methods: Prospective study of 8 children with CD (6 male), aged 14.8 years (9.0–16.4), who received rhGH for 24 months. Serum procollagen type 1 N-terminal propeptide (P1NP) was measured at baseline and at 6 months. DXA was performed every 6 months. Results: Six months of rhGH led to improvement in P1NP SDS adjusted for bone age from –3.6 (–7.9 to –0.9) to –2.4 (–3.7 to 0.4) (p = 0.01). At baseline, reduction in LS-BMAD and TB lean mass SDS was observed being –1.2 (–3.6 to 0.8) (p = 0.01 vs. zero) and –0.8 (–2.4 to 3.0) (p = 0.11 vs. zero), respectively. No significant changes were seen in DXA bone and muscle parameters over the 24 months. Conclusion: Twenty-four months of therapy with rhGH in CD did not lead to an improvement in DXA BMD and lean mass, despite improvement in P1NP and linear growth.


1999 ◽  
Vol 57 (2A) ◽  
pp. 182-189 ◽  
Author(s):  
CLÁUDIO DE NOVAES SOARES ◽  
NINA ROSA MUSOLINO ◽  
MALEBRANCHE CUNHA NETO ◽  
MARIA ADELAIDE CAIRES ◽  
MARIA CRISTINA ROSENTHAL ◽  
...  

BACKGROUND: Untreated GH-deficient adults have a diversity of dysfunctions (e.g. reduced muscle strength, emotional instability during stress, depressive symptoms) that may cause deleterious effects on quality of life, and may be positively influenced by recombinant human growth hormone (rh-GH) therapy. AIM: To evaluate the impact of a clinical intervention with rh-GH therapy on GH - deficient adults. METHOD: The physical, psychiatric and neuropsychological status of 9 GH-deficient adults was determined before and after the administration of rh-GH (0.250 IU/Kg/week) in a double blind placebo-controlled trial for six months. Patients then received rh-GH for a further period of 6 months and their status was re-evaluated. RESULTS: Rh-GH was significant better than placebo at 6th month (p<0.05), producing increased serum Insulin like growth factor-I (IGF-1) levels, reduced body mass index (BMI) and body fat, increased lean body mass and water, reduced waist/hip ratio and increased energy expenditure. The rh-GH therapy was also significantly better than placebo on depressive features as measured by the Hamilton Depression Scale (17-items) (p= 0.0431) and the Beck Depression Inventory (p= 0.0431). Neuropsychological evaluations showed significant improvements in measures of Attention: Digit Backward (p= 0.035),Verbal Fluency (FAS) (p= 0.02) and Cognitive Efficiency (WAIS-R tests): Vocabulary (p= 0.027) , Picture Arrangements (p= 0.017), and Comprehension (p= 0.01) following rh-GH therapy. CONCLUSION: The clinical, psychiatric, and neuropsychological impairments of untreated GH-deficient adults can be decreased by rh-GH therapy.


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