Insulin Mucoadhesive Liposomal Gel for Wound Healing: a Formulation with Sustained Release and Extended Stability Using Quality by Design Approach.

The present study deals with the formulation of topical insulin for wound healing with extended stability and sustained release, by applying quality by design concepts. Insulin has been promoted as a promising therapeutic wound healing agent. Topical formulation of insulin faced major problems, as it cannot be delivered safely to the wound with a controlled rate. Formulation of insulin-loaded vesicles in optimized bio-adhesive hydrogels has been explored to ensure a safe delivery of insulin to wounds in a controlled manner. Quality by design (QbD) was applied to study the effect of several critical process parameters on the critical quality attributes. Ishikawa diagram was used to identify the highest risk factors, which were screened by a fractional factorial design and augmented by Box-Behnken design. The optimized formula was incorporated into a mucoadhesive gel, which was further subjected to stability and clinical studies. An optimized formula was obtained with a particle size of 257.751 nm, zeta potential - 20.548 mv, 87.379% entrapment efficiency, and a release rate of 91.521 µg/cm2/h. The results showed that liposomal insulin remained stable for 6 months in aqueous dispersion state at 4°C. Moreover, the release was sustained up to 24 h. The clinical study showed an improvement in the wound healing rate, 16 times, as the control group, with magnificent reduction in the erythema of the ulcer and no signs of hypoglycemia. Insulin-loaded liposomal chitosan gel showed a promising drug delivery system with high stability and sustained release.

Nanovesicular Photodynamic Clinical Treatment of Resistant Plantar Warts.

BACKGROUND: Photodynamic therapy which involves the use of photosensitizer molecule activated by a light source was proven very promising for the treatment of dermatological diseases, especially the resistant ones such as recalcitrant Plantar Warts (PW). OBJECTIVE: However, its efficacy is hindered by the poor permeation of the photosensitizer molecule required to initiate skin photo-induced effects. METHODS: In this manuscript, the efficiency of the nano-vesicular system (transfersomes) as a potential topical drug delivery system for the photosensitizer methylene blue (MB) was investigated following clinical Photodynamic Therapy (PDT) in patients suffering from PW. RESULTS: Results revealed that MB transfersomal gel displayed a higher complete healing percentage for the lesions compared to the free MB gel (86.67% versus 53.57%) achieved at a lower number of treatment sessions (2.2 versus 4.14). Patients reported no signs of pain or inflammation, with no recurrence of the lesions during the follow up period of 8 months. CONCLUSION: PDT using transfersomal MB is an effective and safe therapeutic modality for the treatment of PW.

What is under the hump? Mass spectrometry based analysis of complex mixtures in processed food--lessons from the characterisation of black tea thearubigins, coffee melanoidines and caramel.

In this contribution we review our work on the characterisation of processed food. We review novel methods and analysis strategies developed to account for the composition of extraordinarily complex materials such as black tea thearubigins, coffee melanoidines and thermally treated carbohydrates. Our methods are mainly based on modern mass spectrometry and are introduced and critically discussed. A series of novel previously unpublished data interpretation strategies are presented as well. Finally an evaluation of the insight obtained in the composition of selected processed foods is given discussing potential consequences for assessing beneficial and adverse health effects of processed food.