Abstract:Eighty Holstein cows (first, second, or third lactation) were used to evaluate the efficacy of a prolonged-release formulation for sometribove (n-methionyl bovine somatotropin). Cows were fed ad libitum a complete mixed diet and milked twice daily. Cows were allocated randomly by parity to two treatment groups receiving 500 mg sometribove in a prolonged release formulation or excipient at 14-d intervals starting at 60 +/- 3 d postpartum and continuing for 36 wk. Treatment with sometribove increased FCM yield t… Show more
“…The pattern of peak milk response at about day 7 of each 14-day injection cycle in experiment 2 was similar to previous data for formulated zinc-[Met',Leu127]-bGH (Bauman et al 1989). Overall response to 500 mg rbGH/14 days (7-8-10-6 kg/day) in this study was similar to the previous 8-10 kg/day response to daily injection (25 mg/day) of solubilized rbGH variants (Eppard et al 1992 arations used in the follow-up study to experiment 2 averaged 1-28 and 1-33 units/mg protein; equiva¬ lent preparations used in the previous study (Eppard et al 1992) each averaged 1-57 units/mg pro¬ tein.…”
Two studies were designed to examine the pharmacokinetic and galactopoietic potency of three molecular variants of recombinant-derived bovine GH (rbGH): [Met1, Leu127]-bGH, [Ala1, Val127]-bGH and [Ala1, Val127, His133]-bGH. Histidine substitution for arginine at residue 133 of rbGH was shown to impart thrombin resistance. In a Latin square design, nine lactating Holstein cows received a 25 mg rbGH bolus infusion via the jugular vein followed by frequent blood sampling over the next 12 h. The serum GH concentration data were found to fit a two-compartment open model. Neither primary nor secondary kinetic parameter estimates differed significantly (P > 0.05) among the three rbGH variants. Thus, the disposition of GH concentration at time t was described by the equation C(t) = (1295.5 micrograms/l) (e-(0.11/min)(t)) + (317.3 micrograms/l)(e-(0.03/min)(t)). Overall averages were: area under the curve = 27.1 mg.min per l, clearance = 0.15 litres/min per 100 kg and volume of distribution of the central compartment = 2.59 litres/100 kg. The t 1/2 for the two compartments averaged 8.2 and 29.1 min. In the second study, 36 lactating Holstein cows received i.m. injections of one of four oil-based formulation treatments: control vehicle or 500 mg of one of the three rbGH variants every 14 days for 42 days. Average and maximum serum GH concentrations and area under the curve estimates were increased by approximately 3-6 micrograms/l, 5-15 micrograms/l and 40-90 micrograms.day per 1 respectively. Ala1, Val127 rbGH treatments elicited greater blood GH concentrations than [Met1, Leu127]-bGH when administered in an oil-based formulation. Blood GH responses did not directly translate into milk response differences, possibly due to differences in biopotency or receptor availability. Thrombin resistance resulting from substitution of histidine at position 127 of rbGH did not affect blood GH pharmacokinetic parameters or milk response over other rbGH variants.
“…The pattern of peak milk response at about day 7 of each 14-day injection cycle in experiment 2 was similar to previous data for formulated zinc-[Met',Leu127]-bGH (Bauman et al 1989). Overall response to 500 mg rbGH/14 days (7-8-10-6 kg/day) in this study was similar to the previous 8-10 kg/day response to daily injection (25 mg/day) of solubilized rbGH variants (Eppard et al 1992 arations used in the follow-up study to experiment 2 averaged 1-28 and 1-33 units/mg protein; equiva¬ lent preparations used in the previous study (Eppard et al 1992) each averaged 1-57 units/mg pro¬ tein.…”
Two studies were designed to examine the pharmacokinetic and galactopoietic potency of three molecular variants of recombinant-derived bovine GH (rbGH): [Met1, Leu127]-bGH, [Ala1, Val127]-bGH and [Ala1, Val127, His133]-bGH. Histidine substitution for arginine at residue 133 of rbGH was shown to impart thrombin resistance. In a Latin square design, nine lactating Holstein cows received a 25 mg rbGH bolus infusion via the jugular vein followed by frequent blood sampling over the next 12 h. The serum GH concentration data were found to fit a two-compartment open model. Neither primary nor secondary kinetic parameter estimates differed significantly (P > 0.05) among the three rbGH variants. Thus, the disposition of GH concentration at time t was described by the equation C(t) = (1295.5 micrograms/l) (e-(0.11/min)(t)) + (317.3 micrograms/l)(e-(0.03/min)(t)). Overall averages were: area under the curve = 27.1 mg.min per l, clearance = 0.15 litres/min per 100 kg and volume of distribution of the central compartment = 2.59 litres/100 kg. The t 1/2 for the two compartments averaged 8.2 and 29.1 min. In the second study, 36 lactating Holstein cows received i.m. injections of one of four oil-based formulation treatments: control vehicle or 500 mg of one of the three rbGH variants every 14 days for 42 days. Average and maximum serum GH concentrations and area under the curve estimates were increased by approximately 3-6 micrograms/l, 5-15 micrograms/l and 40-90 micrograms.day per 1 respectively. Ala1, Val127 rbGH treatments elicited greater blood GH concentrations than [Met1, Leu127]-bGH when administered in an oil-based formulation. Blood GH responses did not directly translate into milk response differences, possibly due to differences in biopotency or receptor availability. Thrombin resistance resulting from substitution of histidine at position 127 of rbGH did not affect blood GH pharmacokinetic parameters or milk response over other rbGH variants.
“…As was the case with the Oldenbroek et al (1989) study, milk yield increases were cyclic within injection intervals in the Bauman et al (1989) trial. Feed intake did not follow the same cyclical pattern, but rather, increased gradually over the first 10 wk in treated cows.…”
Section: Long-term Production Responsesmentioning
confidence: 82%
“…Gross observations reported by some authors indicate no differences between controls and rbST-treated cows for reproductive efficiency Eppard et at. 1988;reviewed by McBride et al 1988;Bauman et al 1989;Oldenbroek et al 1989). These observations have been confirmed by Eppard et al (1987) and Phipps et al (1988), whose combined results indicated normal estrus cycles, number of days to first ovarian activity and correct insemination, pregnancy rates, embryo or fetal loss, premature calving, and calf development of rbST-treated cows.…”
Section: Concerns Of Producersmentioning
confidence: 94%
“…Rather, the cyclic response to SRV-rbST was likely due to a diminishing quantity of rbST being released at the end of the injection interval. SRVs are in obvious need of fine turning; Bauman et al (1989) pointed out that the cyclical nature of milk yield responses under current product application may be less than responses from a comparable amount of rbST given as a daily injectable.…”
“…Asimov and Krouze in 1937 first demonstrated injections of pituitary extract increased milk production in dairy cows ( 1). Investigators since then have shown bovine somatotropin regulates metabolic processes resulting in more efficient milk synthesis, greater milk production and increases lean tissue synthesis (2)(3)(4). With the advancement in recombinant DNA technology, production and isolation of bovine somatotropin became commercially feasible.…”
Section: Introduction Foster and Leathermanmentioning
The powder characteristics of bovine somatotropin and casein spray-dried from laboratory, pilot and production spray-dryers were investigated. The powder characteristics examined included particle size distribution and morphology; bulk density; and flowability as measured by angle of repose, compressibility index and shear cell indices. Morphology classification showed internal voidage, blowholes, expanded, smooth and folding for somatotropin and casein spray-dried from the various spray-dryers. Particle size distributions of the bovine somatotropin and casein were unimodal and skewed. As the drying-chamber size of the spray-dryer increased, the particle sizes of both somatotropin and casein increased from mean volume diameters of 6-8 p using the laboratory and pilot spray-dryers to 13-24 p when using the production size spray-dryers. Spray-dried bovine somatotropin and casein had bulk densities of 0.090 to 0.195 g/cm3. Three flowability tests showed casein and somatotropin spray-dried from the different spray-dryers exhibited poor flow which could result in pharmaceutical manufacture challenges. The morphology and flowability of the two spray-dried proteins remained the same when comparing material produced from all four spray-dryers. However, the mean volume diameter, particle size distribution and bulk density did vary which might change critical product characteristics during scale-up. In general, similar morphology, particle size distributions, flowability and bulk densities were observed when comparing spray-dried casein and bovine somatotropin produced from the same model spray-dryer. Casein is recommended as a model protein for powder characterization during spray-drying and early formulation manufacture process development when adequate quantities of the recombinant protein are not available.
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