Glucose solutions for injections manufacturing technology and quality assessment and stability tests

Objective: To perform a quality evaluation of glucose solutions for injections and recommend the date of minimum durability for these products. Main tasks: 1. To review previous studies on physical, chemical characteristics of glucose and also pharmacological characteristics. 2. Prepare stability study protocol of glucose solution and prepare product specification. 3. To evaluate stability of the products in accordance with the ICH requirements. 4. To analyze the stability studies, and provide a conclusions about the product stability. Research methods: In this study was tested glucose 10 per cent and 40 per cent solutions for injections produced at pharmacy of LUHS hospital Kaunas clinics. Long-term and accelerated stability tests were carried out. The amount of glucose was determined using polarimetric method, glucose degradation products was determined using UV spectrophotometry method. Results: Glucose solutions for injections in LUHS hospital KK pharmacy manufactured in accordance with good pharmacy practice standards, glucose solutions stages of production associated with classic sterile preparations production stages. Glucose 10 % and 40 % solutions for injections quantitative evaluation performed polarimetric method. Only produced in two levels, each series of solutions the concentration did not exceed the limits of ± 5 %, this leads to the conclusion that the preparation of production operation and of the production process of in a pharmacy carried out properly. The stability studies showed that glucose solutions as the long-term stability study conditions and accelerated stability study conditions does not change in appearance – remains transparent and colorless, and the pH value is below the limits (from 3.0 to 4.1). The study found HMF content also does not exceed the threshold (absorption of not more than 0.25). Long-term stability test results showed that changes of glucose amount after expiration of shelf-life (after 3 months) and after 4 months does not exceed ± 5 % limit. The accelerated stability study also showed that, after expiry of shelf-life (after 3 months) and after 4 months, glucose amount changes does not exceed ± 5 limit. Conclusions: 1. Was evaluated glucose physical and chemical properties, to estimate amount of glucose and HMF needed sensitive analysis methods. Glucose solutions for medical purposes used in large quantities, it is necessary to strict quality control. 2. The specification of the control product quality was formed. The specification covers general (appearance, pH) and specific (glucose and hydroxymethylfurfural content) quality indicators are sufficient to ensure product quality. 3. Glucose solutions for injections are stable. The evaluation results of the research, 10 per cent glucose solutions for injections into shelf life may be 4 months and 40 percent glucose solutions for injections – 3 months when stored at temperatures below 25°C temperature. 4. During the 4-month accelerated stability study has not been established higher results than the indicator deviation is allowed, while the general trend does not indicate that there is a threat that after 6 months determine quality indicators exceed allowed limits, it is likely that the products will remain stable for 6 months