Tablet Development for a Hydroscopic Drug Using Solid Dispersion

Abstract

Introduction. Traumatic brain injury is a damage to the brain from an external mechanical force, possibly leading to permanent or temporary impairment of cognitive, physical, and psychosocial functions. It is a leading cause of death and disability among children and young adults. In connection with the above, the objective of developing new, more effective nootropic and antiasthenic drugs in the framework of restorative neurology is considered as one of the priority tasks of medical science in Russia.Aim. Development the composition and technology of tablets containing a hygroscopic substance using solid dispersions.Materials and methods. The pharmaceutical substance of a diethylaminoethanol derivative having antihypoxic, neuroprotective, adaptogenic and antioxidant effects is a hygroscopic powder. PEG 6000 was chosen as a matrix for solid dispersion production. Solid dispersions were obtained by high shear mixing and hot-melt extrusion. The technological properties of granulate and the quality indicators of the tablets were determined according to the methods described in the State Pharmacopoeia of the Russian Federation (14th edition).Results and discussion. The lactose mixed with the DEAE-PEG composition alloy improve the technological properties of granulate.Conclusion. A decrease water-absorbing ability of DEAE was achieved using PEG 6000 as a matrix carrier. The increase PEG content did not lead to a significant change in the kinetics of the release of DEAE from tablets.

Keywords

• traumatic brain injury
• neuroprotective agent
• tablets
• solid dispersion
• hygroscopicity