Validasi Metode Analisis Matriks Patch Domperidon Maleat dengan Perbedaan Polimer Menggunakan Spektorfotometri UV-Vis

Uv-Vis spectrophotometry is an analytical method that can be used to determine the levels of domperidon maleate contained in transdermal patches with different polymers. The analysis method needs to be validated to prove that it can provide measurement results that match its designation. The purpose of this study is to prove that uv-vis spectrophotometry methods can provide the specificity, linearity, thoroughness, and precision that meet the requirements. In this study, linearity was known by calculating the r value on the curve of the relationship between levels and absorbance. Precision is obtained based on rsd value. Accuracy is calculated based on the return value. Selectiveity is known by means of identity confirmation that calculates the absorbance ratio at different wavelengths. The results showed that the method meets the requirements with a value of r=0.999; RSD precision results at a level of 10 ppm obtained RSD 0.236%. The accuracy values of 80%, 100%, and 120% in the matrix of transdermal domperidon maleate patches with PVA and PVP polymers respectively recovery was 99.50%, 101.15%, and 99.13%.. In the matrix of transdermal patches domperidon maleate with polymers HPMC and Na-CMC respectively recovery was 100.91%, 100.31%, and 100.67%. In the matrix of transdermal domperidon patches with HPMC and EC polymers respectively recovery was 98.00%, 98.00%, and 99.00%. The identity confirmation results on the transdermal domperidon patch matrix with PVA and PVP polymers, HPMC and Na-CMC, as well as HPMC and EC respectively have ratio value close to the standard solution with an average value of 0.800; 0,806; and 0.808. It can be concluded that the method of analyzing the levels of domperidone maleate in matrix of transdermal patches has qualified for good validity.

Formulation and Evaluation of Transdermal Patch of Thiochochicoside

The aim of the study is to formulate and evaluate transdermal patches of Thiocholchicoside In the present study, matrix type were prepared by moulding techniques. This mode of drug delivery is more beneficial for chronic disorders such as Rheumatoid arthritis which require long term drug administration to maintain therapeutic drug concentration in plasma. Transport of drugs or compounds via skin is a complex phenomenon, which allows the passage of drugs or compounds into and across the skin. In the present work an attempt has been made to formulate and evaluate the transdermal patches of Thiocholchicoside using various blends of polymer. The polymeric combinations EC/PVP and EC/HPMC used for the formulation of transdermal patches showed good film forming property. The patches formed were thin, flexible, smooth and transparent. The weight variation tests showed less variation in weight and suggesting uniform distribution of drug and polymer over the mercury surface. The thicknesses of the transdermal patches were found to increase on increasing concentration of hydrophilic polymers like PVP and HPMC.All the patches showed good flexibility and folding endurance properties. The result suggests that the formulations with increased hydrophilic polymer concentration showed long folding endurance. The moisture content in the patches was found to be low and formulations with more hydrophilic polymer concentrations showed more percentage moisture content. The in-vitro drug release studies showed that formulations TDP2, TDP3, TDP4, and TDP5 with increased concentration of hydrophilic polymer showed rapid release. The drug content analysis showed minimum variations suggesting uniform distribution of drug.

Application of Gas Chromatography for the Analysis of Residual Solvents in Transdermal Drug Delivery Systems (TDS)

Background: Transdermal drug delivery systems (TDS) are widely used to deliver a number of different drug therapeutics. The design delivery can be impacted by excipients and, more broadly, organic solvents. Organic or residual solvents are routinely monitored due to safety concerns. However, there is little information on the mechanical properties and delivery performance of TDS. Objective: The objective of this study was to develop and validate an efficient GC-Headspace method to determine the residual solvents (n-heptane, o-xylene, and ethyl acetate) in transdermal patches. The analytical method was applied to monitor residual solvents in TDS and evaluate the potential effect of the residual solvent levels on the TDS adhesion properties. Methods: An Agilent GC 7890A was integrated with an Agilent headspace analyzer 7697A system and was used for method development, analytical method validation, and the testing phases of the study. For the analysis of residual solvents in TDS, 2cm x 3cm, a TDS sample was placed in a 20 mL Headspace vial containing 2 mL of a DMSO/water (1:1, v/v) solvent mixture, and an external standard (cyclohexane) was extracted by the headspace analyzer. The system suitability test was conducted according to USP <621>, and analytical method validation was conducted according to USP <1225> over 3 days for validation and was also performed during in-study sample analysis. Results: The resolution between the solvents was acceptable (2.5, %RSD = 8.0). Intra- and inter-day accuracy and precision of all quality control standards as well as the spiked standards in the transdermal patches were found to be acceptable with RSD% ≤ 10% and accuracy ≥ 85%, respectively. Linearity was > 0.99 for all analytes. Conclusion: The validated GC-Headspace method was successfully applied to a pilot study for in-house manufactured TDS patches to study the impact of residual solvent concentration on adhesion performance.

A REVIEW ON TRANSDERMAL PATCHES USED AS AN ANTI-INFLAMMATORY AGENT

The transdermal drug delivery system is widely accepted due to its numerous advantages as it is a non-invasive drug administration process with prolonged therapeutic effect, reduced side effects, improved bioavailability, better patient compliance, and easy termination of drug therapy. Non-steroidal anti-inflammatory drugs such as Diclofenac sodium, Lornoxicam, Aceclofenac, Ibuprofen, antihypertensive drugs, for example, Repaglinide, Atenolol, and Antiviral agents such as Stavudine, zidovudine represents the most commonly used medications for the treatment of pain and inflammatory reaction but various side effects can limit their use. Therefore, transdermal delivery of these drugs has advantages of avoiding hepatic first-pass effect, gastric irritation and delivering the drug for an extended period of time at a sustained level. The present article mainly focuses on the work been done on these drugs by formulated and delivered as transdermal patches to decrease the side effects related to the oral delivery.

Monitoring the Effect of Transdermal Drug Delivery Patches on the Skin Using Terahertz Sensing

Water content of the skin is an important parameter for controlling the penetration rate of chemicals through the skin barrier; therefore, for transdermal patches designed for drug delivery to be successful, the effects of the patches on the water content of the skin must be understood. Terahertz (THz) spectroscopy is a technique which is being increasingly investigated for biomedical applications due to its high sensitivity to water content and non-ionizing nature. In this study, we used THz measurements of the skin (in vivo) to observe the effect of partially and fully occlusive skin patches on the THz response of the skin after the patches had been applied for 24 h. We were able to observe an increase in the water content of the skin following the application of the patches and to identify that the skin remained hyper-hydrated for four hours after the removal of the fully occlusive patches. Herein, we show that THz spectroscopy has potential for increasing the understanding of how transdermal patches affect the skin, how long the skin takes to recover following patch removal, and what implications these factors might have for how transdermal drug patches are designed and used.

Fabrication of Tizanidine Loaded Patches Using Flaxseed Oil and Coriander Oil as a Penetration Enhancer for Transdermal Delivery

Transdermal drug delivery is important to maintain plasma drug concentrations for therapeutic efficacy. The current study reports the design, formulation, and evaluation of tizanidine transdermal patches formulated using chitosan and thiolated chitosan, ethyl cellulose (EC), polyvinylpyrrolidone (PVP), and Eudragit RL100 in different ratios. The tizanidine patches were formulated using flaxseed oil and coriander oil in the concentrations of 1% v/w, 2% v/w, 3% v/w, 4% v/w, 5% v/w, and 10% v/w. The patches were subjected to characterization of physicochemical property (thickness, weight uniformity, drug content, efficiency, percentage moisture uptake/loss), in vitro drug release and drug permeation, skin irritation, in vivo application, pharmacokinetics analysis, and stability studies. The results indicate that the interaction of thiolated chitosan with the negative charges of the skin opens the tight junctions of the skin, whereas flaxseed and coriander oils change the conformational domain of the skin. The novelty of this study is in the use of flaxseed and coriander oils as skin permeation enhancers for the formulation of tizanidine transdermal patches. The formulations follow non-Fickian drug release kinetics. The FTZNE23, FTZNE36 and FTZNE54, with 5% v/w flaxseed oil loaded formulations, exhibited higher flux through rabbit skin compared with FTZNE30, FTZNE35, FTZNE42, and FTZNE47, formulations loaded with 10% v/w coriander oil. The study concludes that flaxseed oil is a better choice for formulating tizanidine patches, offering optimal plasma concentration and therapeutic efficacy, and recommends the use of flaxseed and coriander oil based patches as a novel transdermal delivery system for tizanidine and related classes of drugs.

"FORMULATION AND EVALUATION OF MORONIC ACID LOADED TRANSDERMAL PATCHES"

Objective: To prepare Transdermal patches of Moronic acid along with various polymers for controlled release action. Methods: Suitable method such as Solvent Casting Technique of Film Casting Technique are used for the preparation of Transdermal patch. Results: The prepared Transdermal patches were transparent, smooth, uniform and flexible. The method adopted for the preparation of the system was found satisfactory. Conclusion: Various formulations were developed by using hydrophilic and hydrophobic polymers like HPMC E5 and EC respectively in single and combinations by solvent evaporation technique with the incorporation of penetration enhancer such as dimethylsulfoxide and dibutyl phthalate as plasticizer. Formulation F7 containing an equal ratio of HPMC E5: EC (5:5) showed maximum and sustained release of 86.814±0.262 within 24 h. Kinetic models were used to confirm the release mechanism of the formulations. Moronic acid release from the patches F1 to F7 followed non Fickian diffusion rate controlled mechanism.

FORMULATION AND EVALUATION OF MASLINIC ACID LOADED TRANSDERMAL PATCHES

Objective: To develop and evaluate Transdermal patch of Maslinic acid for Transdermal drug delivery. The current study is to develop Transdermal drug delivery system. Methods: Suitable method such as Solvent Casting Technique of Film Casting Technique are used for preparation of Transdermal patch. Results: The prepared Transdermal patches were transparent, smooth, uniform and flexible. The method adopted for the preparation of the system was found satisfactory. Conclusion: Various formulations were developed by using hydrophilic and hydrophobic polymers like HPMC E5 and EC respectively in single and combinations by solvent evaporation technique with the incorporation of penetration enhancer such as dimethylsulfoxide and dibutyl phthalate as plasticizer In vitro studies concluded that HPMC E5 patches has better release than that of EC patches, which may be attributed to high water vapour permeability of HPMC patches and hydrophobic nature of EC. An attempt was made to incorporate HPMC E5 and EC to the monolithic system for better release and prolong the duration of release. Formulation F7 containing an equal ratio of HPMC E5: EC (5:5) showed maximum and sustained release of 86.816±0.264 within 24 h. Kinetic models were used to confirm the release mechanism of the formulations. Maslinic acid release from the patches F1 to F7 followed non Fickian diffusion rate controlled mechanism.