Transdermal Hydrogel Research Articles

Mesenchymal stem cells in the treatment of Cesarean section skin scars: study protocol for a randomized, controlled trial

BackgroundCesarean delivery has already become a very common method of delivery around the world, especially in low-income countries. Hypertrophic scars and wound infections have affected younger mothers and frustrated obstetricians for a long time. Mesenchymal stem cells (MSCs) have strong potential for self-renewal and differentiation to multilineage cells. Previous studies have demonstrated that MSCs are involved in enhancing diabetic wound healing. Therefore, this study is designed to investigate the safety and efficacy of using MSCs in the treatment of Cesarean section skin scars.MethodsThis trial is a prospective, randomized, double-blind, placebo-controlled, single-center trial with three parallel groups. Ninety eligible participants will be randomly allocated to placebo, low-dose (transdermal hydrogel MSCs; 3 × 106 cells) or high-dose (transdermal hydrogel MSCs; 6 × 106 cells) groups at a 1:1:1 allocation ratio according to a randomization list, once a day for six consecutive days. Study duration will last for 6 months, comprising a 1 week run-in period and 24 weeks of follow-up. The primary aim of this trial is to compare the difference in Vancouver Scar Scale rating among the three groups at the 6th month. Adverse events, including severe and slight signs or symptoms, will be documented in case report forms. The study will be conducted at the Department of Obstetric of Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan.DiscussionThis trial is the first investigation of the potential for therapeutic use of MSCs for the management of women’s skin scar after Cesarean delivery. The results will give us an effective therapeutic strategy to combat Cesarean section skin scars, even with uterine scarring.Trial registrationClinicalTrials.gov, NCT02772289. Registered on 10 May 2016.

Penetration enhancer-containing spanlastics (PECSs) for transdermal delivery of haloperidol: in vitro characterization, ex vivo permeation and in vivo biodistribution studies

Haloperidol (Hal) is one of the widely used antipsychotic drugs. When orally administered, it suffers from low bioavailability due to hepatic first pass metabolism. This study aimed at developing Hal-loaded penetration enhancer-containing spanlastics (PECSs) to increase transdermal permeation of Hal with sustained release. PECSs were successfully prepared using ethanol injection method showing reasonable values of percentage entrapment efficiency, particle size, polydispersity index and zeta potential. The statistical analysis of the ex vivo permeation parameters led to the choice of F1L – made of Span® 60 and Tween® 80 at the weight ratio of 4:1 along with 1% w/v Labrasol® – as the selected formula (SF). SF was formulated into a hydrogel by using 2.5% w/v of HPMC K4M. The hydrogel exhibited good in vitro characteristics. Also, it retained its physical and chemical stability for one month in the refrigerator. The radiolabeling of SF showed a maximum yield by mixing of 100 µl of diluted formula with 50 µl saline having 200 MBq of 99mTc and containing 13.6 mg of reducing agent (NaBH4) and volume completed to 300 µl by saline at pH 10 for 10 min as reaction time. The biodistribution study showed that the transdermal 99mTc-SF hydrogel exhibited a more sustained release pattern and longer circulation duration with pulsatile behavior in the blood and higher brain levels than the oral 99mTc-SF dispersion. So, transdermal hydrogel of SF may be considered a promising sustained release formula for Hal maintenance therapy with reduced dose size and less frequent administration than oral formula.

Formulation of Novel Glycerin Nanoparticles for Enhancement the Solubility of Loratadine; Application to Transdermal Hydrogel Delivery System

Owing to its slightly aqueous solubility, loratadine (LOR) is used in high doses in different marketed formulations to achieve its desirable bioavailability. The aim of this work is to formulate novel LOR-glycerin nanoparticles (LOR-GNPs) to increase LOR bioavailability. LOR-GNPs were prepared by a precipitation method and then evaluated for such size and morphology using dynamic scattering spectroscopy (DLS) and scanning electron microscopy (SEM), as well as the percentage entrapment efficiency (EE%) of free LOR from GNPs formulations was performed using titration method. Furthermore, the GNPs were formulated in hydrogel. The hydrogel viscosity, spreadability, homogeneity and abdominal rat skin permeation were studied and optimized DLS indicated a successful coating of LOR with glycerin surface that recorded an average size of 334 ± 30 nm with uniform particle size, while SEM showed LOR-NPs in different shapes. The EE% free LOR was found to be satisfactory with a mean content of 98.1 ± 0.3 and a relative standard deviation below 2.0% indicates the reproducibility of the LOR release. LOR-GNPs were formulated as a hydrogel to check their suitability for a dosage form usage. The hydrogel showed accepted viscosity, spreadability, and homogeneity. The results proved that the GNPs penetrated abdominal rat skin. The obtained results showed that LOR-GNPs are considered a new addition for improvement of LOR solubility when applied as a hydrogel. The developed method could be used for different insoluble candidates.

Application of Thermosensitive Poloxamer-Based Hydrogel in the Development of Transdermal Therapy Containing Herbal Medicine

Poloxamer 407 exhibits remarkable reversible sol gel transition which makes it attractive and promising in the application of transdermal therapy. This study mainly reports the skin permeation properties of model drug from poloxamer 407 based transdermal hydrogel therapy with the presence of chemical penetration enhancers. Poloxamer 407 based hydrogel was shown porous structure which faciliates the diffusional release of model drug. Compared with borneol and 1,2-propanediol, azone was the most effective enhancer for gallic acid skin permeation, and 3% of azone presented the optimal enhancement effect. This study also demonstrated that the selection of enhancers is of great importance for the skin permeation of model drug.

Preparation and <I>In Vitro, In Vivo</I> Characterization of Thermosensitive Transdermal Hydrogel for Arthritis

Preparation and <I>In Vitro, In Vivo</I> Characterization of Thermosensitive Transdermal Hydrogel for Arthritis

Improved Skin Penetration Using In Situ Nanoparticulate Diclofenac Diethylamine in Hydrogel Systems: In Vitro and In Vivo Studies.

Delivering diclofenac diethylamine transdermally by means of a hydrogel is an approach to reduce or avoid systemic toxicity of the drug while providing local action for a prolonged period. In the present investigation, a process was developed to produce nanosize particles (about 10 nm) of diclofenac diethylamine in situ during the development of hydrogel, using simple mixing technique. Hydrogel was developed with polyvinyl alcohol (PVA) (5.8% w/w) and carbopol 71G (1.5% w/w). The formulations were evaluated on the basis of field emission scanning electron microscopy, texture analysis, and the assessment of various physiochemical properties. Viscosity (163-165 cps for hydrogel containing microsize drug particles and 171-173 cps for hydrogel containing nanosize drug particles, respectively) and swelling index (varied between 0.62 and 0.68) data favor the hydrogels for satisfactory topical applications. The measured hardness of the different hydrogels was uniform indicating a uniform spreadability. Data of in vitro skin (cadaver) permeation for 10 h showed that the enhancement ratios of the flux of the formulation containing nanosize drug (without the permeation enhancer) were 9.72 and 1.30 compared to the formulation containing microsized drug and the marketed formulations, respectively. In vivo plasma level of the drug increased predominantly for the hydrogel containing nanosize drug-clusters. The study depicts a simple technique for preparing hydrogel containing nanosize diclofenac diethylamine particles in situ, which can be commercially viable. The study also shows the advantage of the experimental transdermal hydrogel with nanosize drug particles over the hydrogel with microsize drug particles.