OBJECTIVE: Development of oxybutynin chloride (OC) proniosomal gels and analyses of its efficacy for OAB treatment.
MATERIALS AND METHODS: Phase separation coacervation was used to prepare proniosomal gels using various non-ionic surfactants, lipids, soy lecithin and isopropyl alcohol. Gels were characterized with regard to entrapment efficiency (EE), vesicle size, surface morphology (using environmental scanning electron microscopy [E-SEM]), stability, attenuated total reflectance Fourier transform infrared (ATR-FTIR) spectroscopy, in vitro skin permeation, in vivo animal studies and histopathology.
RESULTS AND DISCUSSION: EE was 87-92%, vesicle size was 0.38-5.0 μm, and morphology showed some loosened pores in proniosomes after hydration. ATR-FTIR spectroscopy showed no significant shifts in peaks corresponding to OC and excipients. Most formulations exhibited >50% permeation but the cholesterol-containing formulations P3 (Span 20:Span 60 [1:1]) and P4 [Tween 20:Tween 80 (1:1)] had the highest percent cumulative permeation. P3 and P4 also showed faster recovery of cholinergic effects on salivary glands than oral formulations. P3 and P4 had pronounced therapeutic effects in reduction of urinary frequency and demonstrated improvements in bladder morphology (highly regenerative surface of the transitional epithelium).
CONCLUSION: These results suggest that OC could be incorporated into proniosomal gels for transdermal delivery in the treatment of OAB.
METHODS: We enrolled all patients referred for SCI rehabilitation from 2012 to 2015 that fulfilled our study criteria. Data that were retrospectively reviewed included demographic and clinical characteristic data; and US KUB surveillance studies.
RESULTS: Out of 136 electronic medical records reviewed, 110 fulfilled the study criteria. The prevalence of NB in our study population was 80.9%. We found 22(20%) of the patients showed evidence of US diagnosed NB complications with the mean detection of 9.61±7.91 months following initial SCI. The reported NB complications were specific morphological changes in the bladder wall 8(36.4%); followed by unilateral/bilateral hydronephrosis 7(31.8%); bladder and/or renal calculi 5(22.7%); and mixed complication 2(9.1%) respectively. Half of the patients with NB complications had urodynamic diagnosis of neurogenic detrusor overactivity with/without evidence of detrusor sphincter dyssynergia. We found co-existing neurogenic bowel, presence of spasticity and mode of bladder management were significantly associated factors with US diagnosed NB complications (p<0.05), while spasticity was its predictor with adjusted Odds Ratio value of 3.93 (1.14, 13.56).
CONCLUSION: NB is a common secondary medical impairment in our SCI population. A proportion of them had US diagnosed NB complications. Co-existing neurogenic bowel, presence of spasticity and mode of bladder management were its associated factors; while spasticity was its predictor.