Oral jelly of metformin hydrochloride – Formulation development using Design of Experiments and characterization
Metformin hydrochloride is an antihyperglycemic drug, for treatment of type 2 diabetes. The therapeutic dose range is 250 mg–1000 mg in immediate release form. Due to bulky nature of the tablets, there may be difficulty in swallowing to some patients, especially for geriatric patients. A few liquid oral formulations are available in market containing 500 mg per 5 mL dose. However, considering the risk for some dysphagic patients, simple non viscous liquid formulation may pose aspiration and coughing problem which can be fatal and hence, an alternate, unit packaged oral jelly dosage form can be a very good option. Current research paper emphasizes on formulation development, evaluation and formula optimization of metformin hydrochloride oral jelly up to 1000 mg per 5 g strength. The formulations so prepared were palatable and easy for swallowing. The stability of the formulation was conducted in unit dose triple laminated aluminum sachets. The product was found stable at accelerated condition for six months. The oral jelly of metformin hydrochloride can offer good alternate option for use in geriatric patients to resolve swallowing difficulty. The oral jelly can be marketed in unit dosage sachets which are easy to carry, keep the product in stable state up to shelf life hence improve patient compliance. Continue reading here on oral jelly of metformin hydrochloride
Conclusion
Considering the need for dysphagic patients, metformin hydrochloride in the form of oral jelly was successfully developed. The prepared formulations of oral jelly were compared with marketed tablets formulations for dissolution profile and the drug release was found to be equivalent. The challenges of solubilisation of the drug, taste masking were overcome successfully. The product was found to be stable in ICH stability conditions for Zone IVb (long term condition as 30 °C/75%RH). Design of Experiments concept using Design Expert software was used for optimization of formulation. The research work was conducted to develop oral jelly of metformin in immediate release form, for ease of swallowing to offer the finished product in the unit dose packaging and the researcher believe that this would make an important step for patient compliance.
Article information: Shailesh Kulkarni, Vaishali Londhe,
Oral jelly of metformin hydrochloride – Formulation development using Design of Experiments and characterization,
Journal of Drug Delivery Science and Technology, Volume 63, 2021, 102519,
https://doi.org/10.1016/j.jddst.2021.102519.