Results for seven of the eight beta blockers demonstrated to be radioresistant (except nadolol)

Most sensitive drugs, nadolol and esmolol hydrochloride, were studied by HPLC and showed no significant loss of activity

Two different radical species were produced

Gamma radiation dose can be estimated with accuracy better than 6% in the 5–34 kGy dose range when albendazole is used as a dosimetric material

Amylase—enzyme activity and enzyme effect were lowered with doses higher than 7 kGy

Trypsin and pepsin were stable between 7 and 10 kGy

Amylase is sensitive to irradiation; 7 kGy (57–72% activity) and 10 kGy (35–60% activity)

Liquid carbohydrase showed no difference between irradiated and control after 2 weeks, no change if dose is <3 kGy, and slight decrease in activity when >5 kGy after 4 months; after 1 year 60% of the original activity was maintained

Drugs sterilized at less than 10 kGy

No evaluation of drug stability as a consequence of radiation dose

Radiation as well as mechanical treatments induced radical production

Paper describes techniques that can be used as proof that drugs, excipients, and cosmetic products have been irradiated or mechanically treated

Degradation was reported as ≤0.1% of sample

Radiosterilization led to the formation of unique nonvolatile compounds

Similar UV spectra of the radiolytic compounds and cefotaxime suggested close molecular structures

Volatile compounds produced are aldehyde, esters, and sulfide, which are very malodorous compounds (7 species for Cefotaxime sodium salt, 9 species for Cefuroxime sodium salt, 1 species for Ceftazidime)

One compound is suspected to be acetaldehyde O-methyloxime, whose structure comes from the general structure of cephalosporins

After 26 and 57 days of storage, the loss of free radicals were, respectively, 43.3% and 73.3% for latamoxef, and 48.8% and 64% for ceftriaxone

ESR technique can be used for identification and quantification purposes in the irradiation of pharmaceuticals

Several impurities detected by HPLC that were above pharmacopoeia recommendations

Free radicals generated had long shelf lives (multiple years)

Not recommended for gamma/electron sterilization

Estimation of the dose is possible using the ESR spectroscopy

Radiolytic study should be performed to determine the radiolytic products and the feasibility of the gamma sterilization process

Curcumin load did not change after γ-sterilization

Strength of the hydrated foam was reduced

Release of curcumin in vitro was not detected after 6 h

Equations are developed to describe the ESR curve versus dose and storage

Limit of detection and discrimination are 0.5 and 1.5 kGy, respectively

Linear regression is applicable for doses lower than 20 kGy

Discrimination between irradiated and non-irradiated dobutamine is possible after storage longer than 2 years

The amount of impurities changed slightly at doses of 25 kGy or slightly below 25 kGy

Radiosterilization of orciprenaline and fenoterol may be practicable

Additional means is required to validate gamma sterilization

≤1% degradation of sample at the 25 kGy dose

EPR signal in the bioadhesive formulations still visible after 30 days of storage (radicals with long half-lives)

Radicals in the powder did not affect the drug content

Irradiation stimulates the formation of free radicals

Irradiation doses ranging from 10 to 25 kGy could be evaluated post-irradiation by using linear regression

Several degradation products in the case without excipients

>90% recoveries for solutions containing either mannitol, nicotinamide, or pyridoxine-irradiated up to 15 kGy

Radiolytic products levels (ppm) increased with increasing the dose 10 to 200 kGy

Irradiation sterilization in solid dry state 10–25 kGy is feasible

Radiolysis of solid paraben (MP, EP, PP, BP) was not observed by ESR below 5 kGy dose

At doses of 25 kGy, low radiation yields (G ≤10⁻²) (i.e., a measure of molecules formed or destroyed per 100 eV)

Authors concluded that foods, cosmetics, and drugs containing parabens could be radiosterilized

Ritodrine hydrochloride showed degradation of 2.8% at 25 kGy

Radiosterilization is not feasible, especially at high doses

ESR signal was obtained from irradiated samples but not control samples

Lowest dose of 5 kGy resulted in an ESR signal.

Relatively small G-value (<0.1) for irradiated samples shows that sulfonamides were fairly resistant to gamma irradiation

GC-MS of sulfonamides irradiated up to 50 kGy resulted in different radiolytic intermediates

These sulfonamides did not lose antimicrobial activity against E. coli, E. faecalis, P. aeruginosa, or S. aureus; results were expressed as minimum inhibitory concentrations

No sterility assessment was reported within this study

At doses as low as 0.5 kGy, radical species were generated

Low amounts of molecular degradation at 10 kGy

Authors claim that SMH drugs can be sterilized by gamma irradiation

Sterility of SMH irradiated at 10 kGy was not demonstrated

Two radical species of different spectroscopic and kinetic features were reported

Radical species were unstable at higher temperatures with signal intensity decreasing about 50% within 20 min at 350 K.

Authors argue SULT could be a suitable pharmaceutical dosimeter for sterilization with high-energy radiation

Increase in the irradiation dose increases the impurities

Numerical simulations of the free radicals dependence on dose at ambient temperature were performed using linear regression, quadratic fit, and power function

Presence of free radicals could be observed in the sample after ∼60 days

Chromatographic comparison of irradiated versus un-irradiated samples only showed minor changes in the impurity profile

No spectroscopic evidence demonstrated degradation of the aromatic ring or the hydrocarbon tail of the surfactant

Degradation of the polyethoxylated chains was attributed to water radical attack

Flory-Huggins model suggests that even a small fraction of cross-linked species formed after irradiation has a significant effect on the fine hydrophilic/lipophilic balance of the surfactant