Studies of Hydroxypropylmethylcellulose Acetate Succinate on Fertility in Rats

Semi-solid albumin solder improved mechanical properties for laser tissue welding

“…HPMC is a synthetic watersoluble nonstarch polysaccharide that has been safely used in humans and animals to lower cholesterol [16,17]. HPMC has also been found to be safe in teratologic and pharmacologic studies in rabbits, rats, mice, guinea pigs, dogs, and frogs [18][19][20]. When formed, semi-solid solder is flexible and able to be extruded onto the target site.…”

Embryo/fetal development studies with hydroxypropyl methylcellulose acetate succinate (HPMCAS) in rats and rabbits

“…Therefore, the concurrent control group in the cesarean‐section phase of the rat teratology study reported by Hoshi et al (1985c) had an incidence of clubfoot that was 133‐ to 800‐times greater than the historical control incidences for Sprague–Dawley rats in Japan and the US, respectively. Third, in the rat fertility study, clubfoot was noted for 0, 1, 0, and 4 fetuses evaluated at cesarean section in the control, 625, 1250, and 2500 mg/kg dose groups (Hoshi et al, 1985b). The observation of clubfoot in the rat fertility study was not dose dependent and occurred even though exposure terminated on GD 7, before the gestational period for fetal limb development (Hoar et al, 1981).…”

Pharmacobezoar Formation From HPMC-AS-Containing Spray-Dried Formulations in Nonclinical Safety Studies in Rats

“…HPMC-AS has been examined with regard to acute, subchronic, and chronic toxicological effects in a battery of studies by Hoshi et al. 16 -20 As HPMC-AS was found to be only poorly absorbed and toxicologically relevant effects were absent at doses up to 2500 mg/kg/day in rats, HPMC-AS was recognized as safe for use in nonclinical studies. For pharmaceutical use, for example, as a carrier for ASDs, it even gained the GRAS status provided by the United States Food and Drug Administration.…”

“…In some cases, surfactants like sodiumdodecylsulfate (SDS) or viscosity enhancers such as hydroxyethylcellulose (HEC) may be added to the vehicle to improve wettability of the SD-ASDs and homogeneity of the suspension. 5,15 HPMC-AS has been examined with regard to acute, subchronic, and chronic toxicological effects in a battery of studies by Hoshi et al [16][17][18][19][20] As HPMC-AS was found to be only poorly absorbed and toxicologically relevant effects were absent at doses up to 2500 mg/kg/day in rats, HPMC-AS was recognized as safe for use in nonclinical studies. For pharmaceutical use, for example, as a carrier for ASDs, it even gained the GRAS status provided by the United States Food and Drug Administration.…”