Background The research was aimed with an approach to formulate biphasic extended-release system of trospium chloride resulting in controlled release of drug up to 24 h with prospects of better control on urinary frequency, efficacy, tolerability, and improved patient compliance. The push–pull osmotic pump (PPOP) bi-layered tablet of trospium chloride (60 mg) was developed with the use of immediate-release polymers in the pull layer (30 mg drug) and polyethylene oxide in the push layer (remaining 30 mg drug). The tablet was formulated by compression after non-aqueous granulation, seal coating, and semipermeable coating. The tablet prepared was laser drilled to create an orifice for drug release. Results Comparative in vitro dissolution and in vivo pharmacokinetic analysis of available marketed formulations demonstrated the complete drug release within 16–18 h; hence the developed biphasic extended-release system has its great importance as it provides zero-order release up to 24 h. Conclusions The developed biphasic extended-release drug delivery system of trospium chloride provides the drug release for 24 h with effective plasma concentration in comparison with the available marketed formulation. Extended release of drug from the developed formulation provides scope for its promising application in the treatment of overactive bladder (OAB).

Valganciclovir HCl (VGH) is the widely used drug for the treatment of Cytomegalovirus (CMV) retinitis infection with an induction dose of 900mg twice a day and a maintenance dose of 900mg. This required dose of the drug also leads to multiple side effects due to repeated administration. The research was highlighted to develop, formulate, optimize and evaluate Single-Core Osmotic Pump (SCOP) tablet of VGH with the dose of 450mg to reduce dosing frequency and associated side effects. . The decrease in dose also minimize the hepatic and nephrotic load. The optimized batch of formulation was subjected to comparative in vitro and in vivo evaluation. The tablet core composition is the primary influencer of the drug delivery fraction in a zero-order, whereas the membrane characteristics control the drug release rate. In-vivo pharmacokinetic studies revealed that the newly developed osmotic formulation has controlled zero-order release for 24 hours with a single dose of 450mg while the marketed formulation requires twice administration within 24 hours to maintain the plasma concentration in the therapeutic window. The developed formulation can be the promising option for the treatment of CMV retinitis with the minimum dose and dosing frequency.

Valganciclovir HCl (VGH) is the widely used drug for the treatment of Cytomegalovirus (CMV) retinitis infection with an induction dose of 900mg twice a day and a maintenance dose of 900mg. This required dose of the drug also leads to multiple side effects due to repeated administration. The research was highlighted to develop, formulate, optimize and evaluate Single-Core Osmotic Pump (SCOP) tablet of VGH with the dose of 450mg to reduce dosing frequency and associated side effects. . The decrease in dose also minimize the hepatic and nephrotic load. The optimized batch of formulation was subjected to comparative in vitro and in vivo evaluation. The tablet core composition is the primary in uencer of the drug delivery fraction in a zero-order, whereas the membrane characteristics control the drug release rate. In-vivo pharmacokinetic studies revealed that the newly developed osmotic formulation has controlled zero-order release for 24 hours with a single dose of 450mg while the marketed formulation requires twice administration within 24 hours to maintain the plasma concentration in the therapeutic window. The developed formulation can be the promising option for the treatment of CMV retinitis with the minimum dose and dosing frequency. MaterialsVGH was obtained as a free sample from Wockhardt Research Centre, Aurangabad (M.S), India, and lactose monohydrate was obtained from DFE Pharma, India.