Formulation And Evaluation of Biodegradable Polymer Triple Layer Coated Multiparticulate System For Colon Targeting

Abstract: In this present research work, the aim was to develop extended on targeted triple layer coated pellets filled capsule system of Curcumin for chronotherapeutic treatment of colon cancer. Materials and Methods: So triple layer coated pellets of curcumin were prepared using pH sensitive polymers by using fluidized bed dryer which was further filled into an empty gelatin capsule. The compatibility was assessed using FT-IR, DSC and SEM studies for pure drug, polymers and their physical mixtures. Results and Discussion: The prepared batches were subjected to physicochemical studies, drug content estimation, in-vitro drug release and stability studies. When FT-IR, DSC and SEM studies were performed, it was found that there was no interaction between curcumin and polymers used. The physicochemical properties of the entire prepared triple layer coated pellets batches were found to be in limits. The drug content percentage in the optimized formulation C9 was found to be 99.86± 0.02%. The optimized triple layer coated pellets-filled-capsule formulation C9 releases curcumin after a lag time of 3.14 ± 1.58, 17.48 ±0.03%, 68.72 ± 0.86%, and 98.46± 0.34% at the end of 2, 5, 9, and 12 h respectively. Conclusion: Thus, a novel colon targeted delivery system of curcumin was successfully developed by filling triple layer coated pellets into an empty gelatin capsule shell for targeting colon cancer treatment

Development and characterization of miconazole nitrate transfersomal gel

Miconazole nitrate (MIC) is an antifungal drug used for the treatment of superficial fungal infections. However, it has low skin permeability. Hence, the basic idea behind the development of such a system, transfersomes is to maintain a sustain release of drug from the dosage form and for target delivery. Miconazole nitrate was formulated as transfersomes, half-life can be increased and the desired effect can be obtained. MIC transfersomes were prepared using a thin lipid film hydration technique. The prepared transfersomes were evaluated with respect to entrapment efficiency (EE%), particle size, and quantity of in vitro drug released to obtain an optimized formulation. The optimized formulation of MIC transfersomes was incorporated into a Carbapol 934 gel base which was for drug content, pH, spreadability, viscosity, in vitro permeation, and in vitro activity. The prepared MIC transfersomes had a high EE% ranging from 65.45% to 80.11%, with small particle sizes ranging from 368 nm to 931 nm. The in vitro release study suggested that there was an inverse relationship between EE% and in vitro release. In 24 hrs the drug release was observed ranging from 79.08% to 88.72%. The kinetic analysis of all release profiles was found to follow Higuchi’s diffusion model. All independent variables had a significant effect on the dependent variables (p-values < 0.05). Therefore, Miconazole nitrate in the form of transfersomes has the ability to penetrate the skin, overcoming the stratum corneum barrier. When the data subjected to zero order and first order kinetics model, a linear relationship was observed with high R2 values for zero order model as compared to first order model and suggested that the formulations followed zero order sustained release

Formulation and in-vitro evaluation of ciprofloxacin HCl floating matrix tablets

Oral drug delivery is the most widely utilized route of administration among all the routes that have been explored for systemic delivery of drugs via pharmaceutical products of different dosage form. Oral route is considered most natural, uncomplicated, convenient and safe due to its ease of administration, patient acceptance and cost-effective manufacturing process. Gastroretentive drug delivery system was developed in pharmacy field and drug retention for a prolonged time has been achieved. The goal of this study was to formulate and in-vitro evaluate Ciprofloxacin HCl controlled release matrix floating tablets. Ciprofloxacin HCl floating matrix tablets were prepared by wet granulation method using two polymers such as HPMC K100M (hydrophilic polymer) and HPMC K15M. All the Evaluation parameters were within the acceptable limits. FTIR spectral analysis showed that there was no interaction between the drug and polymers. In-vitro dissolution study was carried out using USP dissolution test apparatus (paddle type) at 50 rpm. The test was carried out at 37 ± 0.5 0C in 900ml of the 0.1 N HCl buffer as the medium for eight hours. HPMC K100M shows a prolonged release when compared to HPMC K15M. These findings indicated that HPMC K100M can be used to develop novel gastroretentive controlled release drug delivery systems with the double advantage of controlled drug release at GIT pH. On comparing the major criteria in evaluation such as preformulation and in vitro drug release characteristics, the formulation F8 was selected as the best formulation, as it showed the drug content as 99±0.4% and swelling index ratio was 107.14, and in-vitro drug released 61.31±0.65% up to 8 hours. Results indicated that controlled Ciprofloxacin HCl release was directly proportional to the concentration of HPMC K100M and the release of drug followed non-Fickian diffusion. Based on all the above evaluation parameters it was concluded that the formulation batch F8 was found to be best formulation among the formulations F1 to F8 were prepared

Buccal films: A review of therapy possibilities, treatment plans and appropriate evaluation techniques

Due to apparent greater patient acceptance compared to buccal tablets and enormous therapeutic opportunities compared to traditional oral drug delivery methods, particularly for those who suffer from dysphagia, the potential of the mucoadhesive film technology is difficult to ignore. Despite this, there are currently no authorised mucoadhesive buccal films, and the translation of published literature into the commercial market is essentially non-existent. In order to help this patient-centred dosage form become more widely used, this review aims to give an overview of mucoadhesive buccal film technology and highlight crucial areas on which to concentrate scientific efforts. While discussing the patient-related aspects influencing the utilisation of various dosage forms, a number of indications and development potential were noted. A technical description of the processes used to create these films, including solvent casting, hot melt extrusion, inkjet printing, and three-dimensional printing, was also offered. The utilisation of more than thirty mucoadhesive polymers in film formulations was found, and information about their mucoadhesive properties as well as their inclusion with other essential formulation ingredients was supplied

ODFs: a multi-faceted aid to the formulator

The first films introduced into market are around 1970, from then there are many new technologies are developed in preparation and also using polymers. From Natural to synthetic polymers each polymer has their advantages over one another. Various techniques in preparation of oral films such as solvent casting, semi-solid casting, hot-melt extrusion, solid dispersion extrusion and rolling to the modern techniques are developed from time to time. The most recent technique used is 3D printing which forms the films by forming layer on layer. In this literature along with polymers used, methods for preparing of films; approved drugs in orange books and present clinical trial studies were discussed

Regulatory approach for the approval of Artificial intelligence/ Machine language (AI/ML) Based Software as medical devices (SaMD)

Artificial Intelligence and Machine Language (AI/ML)-Based medical technologies has the potential to change the medical care by determining new and significant experience from the huge measure of information produced during the conveyance of medical care each day.The capacity for AI/ML programming to gain from certifiable criticism (preparing) and improve its presentation (variation) makes these advancements particularly arranged among programming as a clinical gadget (SaMD) and a quickly extending territory of innovative work. Our vision is that with fittingly customized administrative oversight, AI/ML-based SaMD will convey protected and powerful programming usefulness that improves the nature of care that patients get. Different types of medical devices and various documentation procedures for the approval of the AI/ML based SaMD was discussed and the modifications or the updates regulatory approach to the SaMD were clearly mentioned for the easy approval considering the IMDRF, GMLP, TPLC and FD&C regulations. The future trend and the current approved SaMd were discussed

FORMULATION AND IN-VITRO EVALUATION OF A NOVEL BIODEGRADABLE POLYMER BASED MICROPARTICULATE SYSTEM FOR POTENTIAL COLON TARGETED DRUG DELIVERY

The objective of present study is to design a novel multiparticulate system for colon targeting drug delivery system of cyclophosphamide (CPM) using biodegradable Konjac glucomannan (KGM) as a carrier for colorectal cancer treatment. Glucomannan is a high-molecular weight, water-soluble, non-ionic polysaccharide extracted from the tuber or root of the elephant yam, also known as konjac (Amorphophallus konjac or Amorphophallus rivieri). cyclophosphamide (CPM) has been the only agent with clinically active against colorectal cancer. Different batches of CPM granules were prepared and coated with KGM. Optimized CPM granules (KGM-STMP) were evaluated for flow properties, granular parameters, weight variation and content uniformity. The prepared formulations were subjected for in-vitro drug release studies in simulated gastric and intestinal fluids. It was found that during 2 hr at pH 1.2 HCl (SGF), 3 hr at pH 7.4 phosphate buffer (SIF) only less than 20% of drug was released. The drug release studies was also carried out in simulated colonic fluid (SCF) of pH 6.8 containing β-mannanase in order to mimic the conditions from mouth to colon. Drug release from 5-FU granules coated with KGM-STMP followed diffusion dependent zero order kinetics. Further, report suggested that konjac glucomannan (KGM) was biodegradable and susceptible to the colonic microfloras under anaerobic environments. Spectroscopic, (FTIR), X-ray Diffraction (X-RD) and DSC studies concluded that no polymer-drug interaction was concluded. Accelerated stability studies indicated that no significant changes, in drug release and micrometric patterns for observed when stored at 40± 2ºC / 75±5% RH. Therefore, it was concluded that konjac glucomannan (KGM) is a promising potential carrier for targeting CPM in the vicinity of colon in order to treat colon cancer effectively. Key words: Cyclophosphamide (CPM), Konjac glucomannan (KGM), multiparticulate system, colon targeted

Regulatory Approach for the Approval of Artificial Intelligence/ Machine Language (AI/ML) Based Software as Medical Devices (SaMD)

Artificial Intelligence and Machine Language (AI/ML)-Based medical technologies has the potential to change the medical care by determining new and significant experience from the huge measure of information produced during the conveyance of medical care each day.The capacity for AI/ML programming to gain from certifiable criticism (preparing) and improve its presentation (variation) makes these advancements particularly arranged among programming as a clinical gadget (SaMD) and a quickly extending territory of innovative work. Our vision is that with fittingly customized administrative oversight, AI/ML-based SaMD will convey protected and powerful programming usefulness that improves the nature of care that patients get. Different types of medical devices and various documentation procedures for the approval of the AI/ML based SaMD was discussed and the modifications or the updates regulatory approach to the SaMD were clearly mentioned for the easy approval considering the IMDRF, GMLP, TPLC and FD&C regulations. The future trend and the current approved SaMd were discussed

Development and Characterization of Miconazole Nitrate Transfersomal Gel

Miconazole nitrate (MIC) is an antifungal drug used for the treatment of superficial fungal infections. However, it has low skin permeability. Hence, the basic idea behind the development of such a system, transfersomes is to maintain a sustain release of drug from the dosage form and for target delivery. Miconazole nitrate was formulated as transfersomes, half-life can be increased and the desired effect can be obtained. MIC transfersomes were prepared using a thin lipid film hydration technique. The prepared transfersomes were evaluated with respect to entrapment efficiency (EE%), particle size, and quantity of in vitro drug released to obtain an optimized formulation. The optimized formulation of MIC transfersomes was incorporated into a Carbapol 934 gel base which was for drug content, pH, spreadability, viscosity, in vitro permeation, and in vitro activity. The prepared MIC transfersomes had a high EE% ranging from 65.45% to 80.11%, with small particle sizes ranging from 368 nm to 931 nm. The in vitro release study suggested that there was an inverse relationship between EE% and in vitro release. In 24 hrs the drug release was observed ranging from 79.08% to 88.72%. The kinetic analysis of all release profiles was found to follow Higuchi's diffusion model. All independent variables had a significant effect on the dependent variables (p-values < 0.05). Therefore, Miconazole nitrate in the form of transfersomes has the ability to penetrate the skin, overcoming the stratum corneum barrier. When the data subjected to zero order and first order kinetics model, a linear relationship was observed with high R2 values for zero order model as compared to first order model and suggested that the formulations followed zero order sustained release