Unraveling the role of cloud computing in health care system and biomedical sciences.

Cloud computing has emerged as a transformative force in healthcare and biomedical sciences, offering scalable, on-demand resources for managing vast amounts of data. This review explores the integration of cloud computing within these fields, highlighting its pivotal role in enhancing data management, security, and accessibility. We examine the application of cloud computing in various healthcare domains, including electronic medical records, telemedicine, and personalized patient care, as well as its impact on bioinformatics research, particularly in genomics, proteomics, and metabolomics. The review also addresses the challenges and ethical considerations associated with cloud-based healthcare solutions, such as data privacy and cybersecurity. By providing a comprehensive overview, we aim to assist readers in understanding the significance of cloud computing in modern medical applications and its potential to revolutionize both patient care and biomedical research.

The physicochemical properties and molecular docking study of plasticized amphotericin B loaded sodium alginate, carboxymethyl cellulose, and gelatin-based films.

Plasticizers are employed to stabilize films by safeguarding their physical stability and avoiding the degradation of the loaded therapeutic drug during processing and storage. In the present study, the plasticizer effect (glycerol) was studied on bioadhesive films based on sodium alginate (SA), carboxymethyl cellulose (CMC) and gelatin (GE) polymers loaded with amphotericin B (AmB). The main objective of the current study was to assess the morphological, mechanical, thermal, optical, and barrier properties of the films as a function of glycerol (Gly) concentration (0.5-1.5 %) using different techniques such as Scanning Electron Microscope (SEM), Texture analyzer (TA), Differential Scanning Calorimeter (DSC), X-Ray Diffraction (XRD), and Fourier Transforms Infrared Spectroscopy (FTIR). The concentration increase of glycerol resulted in an increase in Water Vapor Permeability (WVP) (0.187-0.334), elongation at break (EAB) (0.88-35.48 %), thickness (0.032-0.065 mm) and moisture level (17.5-41.76 %) whereas opacity, tensile strength (TS) (16.81-0.86 MPa), and young's modulus (YM) (0.194-0.002 MPa) values decreased. Glycerol incorporation in the film-Forming solution decreased the brittleness and fragility of the films. Fourier Transform Infrared (FTIR) spectra showed that intermolecular hydrogen bonding occurred between glycerol and polymers in plasticized films compared to control films. Furthermore, molecular docking was applied to predict the binding interactions betweem AmB, CMC, gelatin, SA and glycerol, which further endorsed the stabilizing effects of glycerol in the complex formation between AmB, CMC, SA, and gelatin. The Findings of the current study demonstrated that this polymeric blend could be used to successfully prepare bioadhesive films with glycerol as a plasticizer.

Oridonin supplementation in rabbits may help to improve the outcome of induced atherosclerosis via autophagy induction.

BACKGROUND AND AIM: Inflammation plays a crucial role in the development of atherosclerotic plague. Oridonin is the major active ingredient of the traditional Chinese medicinal herb Rabdosia rubescens. It is a natural terpenoids that is known as a strong anti-inflammatory supplement by acting as a potent inhibitor of the TXNIP/NLRP3 pathway. Hence, it can reduce the severity of inflammation and improve the outcome of atherosclerotic changes. This study aims to evaluate the anti-inflammatory effects of oridonin in the progression of atherosclerotic plague in rabbits. METHODS: Sixty-three male rabbits were included. The rabbits were randomly assigned to one of the three study groups (21 rabbits in each group), normal control diet (NC) fed normal diet for 8 weeks, atherogenic control (AC) fed atherogenic diet (2% cholesterol-enriched diet) for 8 weeks, and oridonin treated group (OT) fed atherogenic diet (2% cholesterol-enriched diet) with oridonin (purity 94%, Sigma-Aldrich, USA) at 20 mg/kg orally daily for 8 weeks. After the end of the study, blood and tissue samples were collected for analysis of various markers of inflammation and atherosclerotic plaque progression. RESULTS: Serum lipids showed a statistically significant improvement in terms of reduction in total cholesterol and low-density lipoprotein (LDL) in the OT group compared to the AC group. This was associated with a significant reduction in serum F2-isoprostane (marker of inflammation) and LC3B (marker of tissue autophagy) between the OT group compared to the AC group. There was also a significant reduction in NLRP3 inflammasome RNA expression in OT group, P<0.001. CONCLUSIONS: In animal model, with atherogenic diet, oridonin supplementation can significantly improve the outcome of atherosclerosis by its strong anti-inflammatory action.

A Review of Nuclear Imaging in Takotsubo Cardiomyopathy.

Takotsubo cardiomyopathy or Takotsubo Syndrome (TTS) is a reversible left ventricular dysfunction syndrome that is increasingly being recognized. Recent advances in nuclear imaging have allowed us to study TTS in greater detail. We searched the PubMed and Medline databases and identified 53 publications with 221 patients reporting nuclear imaging findings in TTS. The age of the patients ranged from 17 to 87 years and were predominantly women (88.2%). The TTS variant was apical (typical) in 170 (76.9%), mid-ventricular in 23 (10.4%), and basal (reverse TTS) in 2 (0.9%). Cardiac perfusion was assessed using 99mTc sestamibi (MIBI) SPECT, 99mTc tetrofosmin SPECT, 201Tl SPECT, 82Rb PET, 201Tl SPECT, and 13N ammonia PET. Additional studies used were 123I MIBG SPECT, 123I BMIPP SPECT, 18F FDG PET, 67Ga citrate, and 11C hydroxy-ephedrine. A perfusion defect was seen in 69 (31.2%), and an inverse perfusion-metabolism mismatch (normal or near-normal perfusion with absent myocardial metabolic activity) was seen in 183 (82.8%) patients. Nuclear imaging has a significant role in evaluating, diagnosing, and prognosticating patients with TTS. As nuclear imaging technology evolves, we will surely gain more insights into this fascinating disorder.

Artificial Intelligence and Precision Medicine: A New Frontier for the Treatment of Brain Tumors.

Brain tumors are a widespread and serious neurological phenomenon that can be life- threatening. The computing field has allowed for the development of artificial intelligence (AI), which can mimic the neural network of the human brain. One use of this technology has been to help researchers capture hidden, high-dimensional images of brain tumors. These images can provide new insights into the nature of brain tumors and help to improve treatment options. AI and precision medicine (PM) are converging to revolutionize healthcare. AI has the potential to improve cancer imaging interpretation in several ways, including more accurate tumor genotyping, more precise delineation of tumor volume, and better prediction of clinical outcomes. AI-assisted brain surgery can be an effective and safe option for treating brain tumors. This review discusses various AI and PM techniques that can be used in brain tumor treatment. These new techniques for the treatment of brain tumors, i.e., genomic profiling, microRNA panels, quantitative imaging, and radiomics, hold great promise for the future. However, there are challenges that must be overcome for these technologies to reach their full potential and improve healthcare.

A review of the presentation and outcome of sarcoidosis in coronavirus disease 2019.

BACKGROUND: In the setting of the current pandemic, concerns have arisen regarding the multisystemic involvement of sarcoidosis and the possible exacerbations in response to the exposure to severe acute respiratory syndrome coronavirus 2. AIM: This study aims to compare the differences in clinical presentation, management, and outcome of coronavirus disease 2019 (COVID-19) between patients with sarcoidosis and those in the general population. METHODS: A literature search was conducted by reviewing original research articles such as case reports, case series, observational studies, and questionnaire-based surveys published in PubMed/Medline, Web of Science, and Google scholar. Data from individual patients in case series and case reports have been pooled to create a data set that was compared with larger such cohorts obtained from several other observational studies. RESULTS: Twenty-seven patients were identified from 14 original articles. No significant differences were found in the clinical manifestations of patients with sarcoidosis presenting with COVID-19 as compared to the general population. The rate of hospitalization in our study was found to be 48.1%. The overall mortality in our study was 7.4%, which is higher than the global average of 2.1%. CONCLUSION: Our observations have reinforced the hypothesis that the presence of additional medical comorbidities is associated with a higher risk of intensive care unit admission. Furthermore, the presence of moderate to a severe limitation in pulmonary functions is an additional risk factor associated with increased hospital admissions and mortality in sarcoidosis. However, neither the diagnosis of sarcoidosis nor ongoing treatment with steroids, methotrexate, or other immunosuppressants was associated with a poorer prognosis in patients with sarcoidosis. RELEVANCE FOR PATIENTS: Patients with sarcoidosis must take added precautions to mitigate the risk of acquiring COVID-19 infection in view of the COVID-19-related mortality rate in this group of patients. Specifically, immunocompromised patients (on immunomodulator drugs and high dose steroids) have been found to have an increased risk of contracting COVID-19. Overall impact on prognostication and outcome in cases requiring hospitalization remains yet to be determined.

Phase transited asymmetric membrane floating nanoparticles: a means for better management of poorly water-soluble drugs.

PURPOSE: Effective remedy to gastrointestinal (GI) side effects caused by poorly water-soluble drugs remains a challenge. Researching for novel techniques to reduce these side effects and increase patient adherence to medical treatment is of interest. The current study aims to develop an innovative nano-sized gastro-retentive drug delivery for better management of poorly water-soluble drugs. METHOD: A non-disintegrating ibuprofen-asymmetric membrane floating nanoparticle (Ibuprofen-AMFNP) was prepared by phase inversion technique to increase the gastric residence of the drug. Powder characterization, solubility, in vitro buoyancy, effect on in vivo inflammatory markers, and polymer diffusibility studies were conducted on the prepared formulation. All UV-spectrophotometric analysis was accomplished through a fiber optic system. RESULTS: The prepared Ibuprofen-AMFNPs were in the nano range of 114.45 nm ±1.31 nm. The formulation was buoyant for 12 h in the dissolution media indicating increased gastric residence, had better solubility and powder characteristics compared to the pure drug. Scanning electron microscopy revealed an outer non-porous and inner porous asymmetric membrane. Ibuprofen-AMFNP followed Higuchi drug release kinetics (p=0.9925) and had a Fickian diffusion release mechanism (n=0.05). Polymer diffusibility study showed that the 24 h stored formulation had faster drug release with no lag time (-923.08 nm/h) compared to a fresh formulation (2526.32 nm/h). The prepared nano-formulation showed a higher percentage of anti-inflammatory (85.144%) effect compared to the pure drug (78.336%). CONCLUSION: Ibuprofen-AMFNP is envisioned to help reduce drug-related GI side effects, improve drug delivery, and thereby increase patient adherence to medical treatment.

Preparation and Evaluation of '3 Cap' Pulsatile Drug Delivery System of Ramipril.

BACKGROUND: Chronotherapeutics, the drug delivery based on circadian rhythm, is recently gaining much attention worldwide. Various diseases like asthma, hypertension, and arthritis show the circadian variation that demands time scheduled drug release for effective drug action. Therefore, the pulsatile drug delivery system has been designed to confer preprogrammed drug delivery. OBJECTIVE: In the present study, a '3 Cap' pulsatile drug delivery system has been developed, optimized, and characterized in order to achieve the floating and pulsatile release of ramipril. METHODS: An optimal response surface design was employed to investigate the effect of isopropanol: formaldehyde vapors for varying time on drug release from the capsules. '3 Cap' pulsatile drug delivery system was evaluated in terms of floating time, density, the effect of gastric flow rate, and type of dissolution apparatus on drug release. RESULTS: Independent variables exhibited a significant effect on the drug release of the prepared formulations. Results showed that time between the release of fractions of dose increased with an increase in formaldehyde: isopropanol ratio and duration of exposure to formaldehyde vapors with no effect of gastric flow rate. CONCLUSION: The results of the designed system revealed that an optimum exposure of 1:2 of isopropanol: formaldehyde vapors for sixty minutes resulted in the desired release of second pulse of dose after a predetermined lag time of 5 hours as desired. '3Cap' system was successful in achieving floating and pulsed release of hypertensive drug opening a 'new lease of life' to the existing drug molecule.

A review of the presentation and outcome of left ventricular thrombus in coronavirus disease 2019 infection.

BACKGROUND: Cardiovascular complications of the coronavirus disease 2019 (COVID-19), which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2), have been documented both in the acute phase and in convalescence. One such complication is the formation of the left ventricular (LV) thrombus. There is a lack of clarity regarding the incidence, risk factors, and management of this complication. AIM: The aim of the study is to identify the clinical presentation, risk factors and outcome of COVID-19 patients with left ventricular thrombus (LVT). METHODS: A literature search was conducted to identify all case reports of COVID-19 with LVT in PubMed/Medline, Embase, Web of Science, and Google Scholar. RESULTS: Among the 65 patients identified, 60 had LVT, either at admission, or during the acute phase of the illness. Six patients with mild symptoms during the acute phase of viral illness had only the COVID-19 antibody test positivity at the time LV thrombus was detected. Few of the patients (23.1%) had no comorbidities. The mean age of the patients was 52.8 years, and the youngest patient was 4 years old. This suggests that LVT formation can occur in young COVID-19 patients with no co-morbid conditions. Most of the patients (69.2%) had more than one site of thrombosis. A mortality rate of 23.1% was observed in our review, and ST-elevation myocardial infarction (STEMI) was diagnosed in 33.3% of those who died. CONCLUSIONS: A high degree of suspicion for LVT must be maintained in patients with known cardiac disease and those with new-onset arterial or venous thromboembolism, and such patients may benefit from a screening echocardiography at admission. RELEVANCE FOR PATIENTS: The patients with preexisting cardiovascular disease must take added precautions to prevent acquiring COVID-19 infection as there is a higher risk of developing LV thrombus. In patients who develop LVT in COVID-19, mortality rate is higher.

Osmotically regulated two-compartment asymmetric membrane capsules for simultaneous controlled release of anti-hypertensive drugs.

In the present study, asymmetric membrane capsules (AMCs) with two compartments were successfully developed for simultaneous delivery of two poorly water-soluble drugs, Atenolol and Amlodipine Besylate, by using solubility modulation approach. Scanning electron microscopy (SEM) before dissolution showed presence of outer dense region and inner porous region for the prepared asymmetric membrane and the pore size increased after dissolution for both outer and inner layer. Diffuse reflectance spectroscopy (DRS) showed no incompatibility between the drug(s) and the excipients used in the study. The developed system was able to control the release of ATN and AMB by increasing the solubility through buffering agents of different strengths (0.25N to 1.0N). As the level of buffering agent was increased, the solubility of drugs also increased inside the asymmetric membrane capsule. The developed system was independent of the agitation intensity of the dissolution fluid but was dependent on the polymer diffusibility and osmotic pressure of the media, which clearly stated that osmotic pumping was the primary mechanism of drug(s) release from AMCs. The results of in-vitro demonstration of effect of membrane thickness on dissolution fluid entering AMCs showed that as the membrane thickness increased the volume of dissolution fluid entering into AMC decreased. The release kinetic studies of different formulations of AMCs showed that formulation code six, which consists of the highest amount of osmotic agents and optimum amount of buffering agents, was the best formulation, and it followed zero order release kinetics (r(2)=0.9990 for ATN and r(2)=0.9988 for AMB).

Asymmetric membrane capsules of phenylephrine hydrochloride: an osmotically controlled drug delivery system.

The aim of the current study was to develop osmotically controlled release system of freely water soluble drug phenylephrine hydrochloride by use of asymmetric membrane capsules to reduce the dosing frequency and consequently improve the patient compliance. Ethyl cellulose asymmetric membrane capsules were developed by phase inversion process and solubility modulation was accomplished by common ion effect wherein sodium chloride was included in the formulation that also served as an osmogen. The effect of formulation variables namely level of polymer (ethyl cellulose), level of pore former (glycerol) and level of osmogen (sodium chloride) on the in vitro release of the drug was evaluated by 2(3) factorial design. Effects of environmental factors on the release rate of the drug from asymmetric membrane capsules were also evaluated. Membrane characterization by scanning electron microscopy showed an outer dense region with less pores and inner porous region for the prepared asymmetric membrane. The dimensional analysis of asymmetric membrane capsule documented the capsules to be of uniform cap and body size comparable to commercial hard gelatin capsules. In vitro release studies results showed that incorporation of higher amount of osmogen not only increased the osmotic pressure but also controlled the drug release for a period of 12 hr. The drug release was inversely proportional to the level of polymer in asymmetric membrane capsule but directly related to the level of pore former in the membrane. The optimized asymmetric membrane capsule (F5) was able to provide zero order release of phenylephrine hydrochloride independent of agitation rate, intentional defect in the membrane and pH of dissolution medium but was dependent on the osmotic pressure gradient between inside and outside of the delivery system.

Chronopharmaceuticals: hype or future of pharmaceutics.

Drugs for several diseases are still given without regard to the time of the day. Variation in dosing time is generally related with the effectiveness and toxicity of many drugs. On the other hand, several drugs affect the circadian clock. The knowledge of interactions between the circadian clock and drugs is valuable in clinical practice. The pharmacodynamics and pharmacokinetics of the medication influence the chronopharmacological phenomena and recent advances in it have made the traditional goal of pharmaceutics rather outdated. Enhanced progress in chronopharmacotherapy can be achieved if an identification of a rhythmic marker for selecting dosing time is done. However, technology involved in development of drug delivery systems (DDS) that match the circadian rhythm, and the unraveling of the relationship between circardian clock and pathology may be the hindrance in its prosperity for now. The Chronopharmaceutical Drug Delivery System (CDDS) has emerged during the last decade as a possible drug delivery system against several diseases, which may lead to the creation of a sub-disciple of pharmaceutics to be explored called 'chronopharmaceutics'. The review addresses the approaches to this sub-discipline, call attention to potential disease-targets, identifies existing technologies, hurdles and future of chropharmaceuticals. Chronopharmaceuticals coupled with nanotechnology could be the future of DDS, and lead to safer and more efficient disease therapy in the future.

In Situ Phase-Transited Asymmetric Membrane Capsules: A Means for Achieving Delayed and Osmotic Release for pH Solubility-Dependant Drugs.

In the present study, an in situ nondisintegrating polymeric capsular system in achieving delayed as well as improved osmotic flow for the model drug cefadroxil was developed. In situ formed asymmetric membrane capsule was prepared by precipitation of the asymmetric membrane (AM) on the walls of conventional hard gelatin capsules in fabricated glass holders via a dry phase inversion process. The effect of different formulation variables were studied based on a 2(3) factorial design as one variable changed from one level to another, namely, the level of osmogen, ethylcellulose, and pore former, apart from studying the effect of varying osmotic pressure and agitation intensity on drug release. Scanning electron microscopy showed an outer, dense, non-porous region and an inner, lighter, porous region for the prepared AM inside, and a gelatin layer outside. Statistical testing (Dunnett multiple comparison test) was applied for in vitro drug release (n = 6) at P < 0.05. The best formulation in the design closely corresponded to the extra design checkpoint formulation by a similarity (f(2)) value of 96.18. The drug release was independent of the agitation intensity but dependent on the osmotic pressure of the dissolution media. The release kinetics followed the Higuchi model, and the mechanism of release was Fickian diffusion. LAY ABSTRACT: The asymmetric membrane capsule (AMC) is a unique drug delivery system that looks like a conventional hard gelatin capsule but has significant advantages over it. In the present study, a system was made that had an outer disintegrating hard gelatin capsule and an inner nondisintegrating polymeric capsular system for delivering a model drug cefadroxil. The inner nondisintegrating polymeric capsular system was the AMC, which was prepared by precipitation of the asymmetric membrane (AM) on the walls of conventional hard gelatin capsules in fabricated glass holders via a dry phase inversion process. The effect of different formulation variables that might affect the drug release were studied based on a 2(3) factorial design. The formulation variables were level of osmogen, ethylcellulose, and pore former. The effect of varying osmotic pressure and agitation intensity on drug release was also studied. Scanning electron microscopy showed an outer, dense, nonporous region and an inner, lighter, porous region for the prepared AM inside, and a gelatin layer outside. Statistical testing was applied for in vitro drug release. Results showed the drug release to be independent of the agitation intensity but dependent on the osmotic pressure of the dissolution media. The release kinetics followed the Higuchi model, and the mechanism of release was Fickian diffusion.

Phase transited and vapor-induced dual capsular system (DCS) for achieving delayed and osmotic release of cefadroxil.

In the present study, an intestinal pH, disintegrating and non-disintegrating dual capsular system using formaldehyde vapor and phase transition technique, respectively, was developed to achieve delayed as well as improved osmotic flow for the model drug cefadroxil. Formaldehyde vapor was used to attain gastric resistance to the outer gelatin capsule, which disintegrated at the intestinal pH to give a non-disintegrating asymmetric membrane capsule (AMC). The AMC was prepared via dry phase inversion process. The effects of different formulation variables were studied based on 2³ factorial design, namely, level of osmogen, ethylcellulose, and pore former, apart from studying the effects of varying osmotic pressure, agitation intensity, and intentional defect on drug release. Scanning electron microscopy showed an outer dense non-porous and an inner lighter porous region for the prepared asymmetric membrane. Statistical test was applied for in-vitro drug release at P > 0.05. The best formulation in the design closely corresponded to the extra design checkpoint formulation by a similarity (f2) value of 95.28. The drug release was independent of the agitation intensity and intentional defect of the film but dependent on the osmotic pressure of the dissolution medium. The release kinetics followed zero-order, and mechanism of release was Fickian diffusion.

Phase Transited Asymmetric Membrane Capsule: A Means for Achieving Delayed and Controlled Osmotic Flow.

In the present study, a phase transited nondisintegrating polymeric capsular system in achieving delayed as well as improved osmotic flow for the model drug cefadroxil was developed. Asymmetric membrane capsule (AMC) was prepared by precipitation of asymmetric membrane (AM) on the fabricated glass mold pins via wet phase inversion process. Effect of different formulation variables were studied based on 23 factorial design, namely, level of osmogen, ethylcellulose, pore former, apart from studying the effect of varying osmotic pressure on drug release. Scanning electron microscopy showed an outer dense non-porous region and an inner lighter porous region for the prepared AMC. Statistical test (Dunnett multiple comparison test) was applied for in vitro drug release (n=6) at P < 0.05. The best formulation in the design closely corresponded to the extra design checkpoint formulation by a similarity factor (f2) of 98.91, and a difference factor (f1) of 2.17. The drug release was independent of agitation intensity but dependent on the osmotic pressure of the dissolution medium. The release kinetics followed Higuchi model, and mechanism of release was Fickian diffusion.

Colon targeted drug delivery systems: a review on primary and novel approaches.

The colon is a site where both local and systemic delivery of drugs can take place. Local delivery allows topical treatment of inflammatory bowel disease. However, treatment can be made effective if the drugs can be targeted directly into the colon, thereby reducing the systemic side effects. This review, mainly compares the primary approaches for CDDS (Colon Specific Drug Delivery) namely prodrugs, pH and time dependent systems, and microbially triggered systems, which achieved limited success and had limitations as compared with newer CDDS namely pressure controlled colonic delivery capsules, CODESTM, and osmotic controlled drug delivery which are unique in terms of achieving in vivo site specificity, and feasibility of manufacturing process.

Egg shell membrane as a substrate for optimizing in vitro transbuccal delivery of glipizide.

Buccoadhesive gels for transbuccal delivery of glipizide were prepared using different bio-adhesive polymers. The gels were prepared by solution polymerization technique. An apparatus simulating the in vivo conditions of the mouth was designed in order to assess in vitro drug release kinetics of these gels. The gels were also evaluated for spreadability, buccoadhesive strength, swelling index, and viscosity. Maximum buccoadhesive strength was observed for formulation, F8 with good sustained release behavior, whereas viscosity and swelling index was highest for the formulation, F5 but with minimum buccoadhesive strength. The drug release kinetics followed Higuchi model with release mechanism being Fickian diffusion.

Optimized prodrug approach: a means for achieving enhanced anti-inflammatory potential in experimentally induced colitis.

In the present study, prodrug of ketoprofen was synthesized and evaluated in vitro to optimize the prodrug, and in vivo to observe the reduction in gastrointestinal disturbance and enhanced colonic anti- inflammatory potential for the prodrug. The prodrug was synthesized by coupling ketoprofen with L-glycine (KET-GLY). In vitro reversion of KET-GLY to ketoprofen was carried out in different pHs and in pH 6.8 containing optimized rat fecal material. In vivo healing potential of KET-GLY was evaluated in acetic acid-induced experimental colitis model. In vitro reversion studies suggested that KET-GLY remained intact in stomach but released the free drug at pH 6.8 containing fresh rat fecal material, where the colonic microfloral enzymes (amidase) hydrolyzed the KET-GLY amide linkage, releasing the free drug. In vivo evaluation indicated KET-GLY to be less toxic in stomach, with enhanced anti-inflammatory potential in the colonic region. These findings suggested KET-GLY to be better in action compared with the parent drug.

Wet process-induced phase-transited drug delivery system: a means for achieving osmotic, controlled, and level A IVIVC for poorly water-soluble drug.

A phase-transited, nondisintegrating, controlled release, asymmetric membrane capsular system for poorly water-soluble model drug flurbiprofen was developed and evaluated both in vitro and in vivo for osmotic and controlled release of the drug. Asymmetric membrane capsules (AMCs) were prepared using fabricated glass mold pins through wet phase inversion process. Effect of varying osmotic pressure of the dissolution medium on drug release was studied. Membrane characterization by scanning electron microscopy showed an outer dense region with less pores and an inner porous region for the prepared asymmetric membrane. In vitro release studies for all the prepared formulations were carried out (n = 6). Statistical test was applied for in vitro drug release at p > .05. Predicted in vivo concentration from in vitro release data closely matched the minimum effective concentration (in vivo) level achieved by the drug from its release through phase-transited AMC in rabbits for the first hour. The drug release was found to be independent of the pH but dependent on the osmotic pressure of the dissolution medium. In vivo pharmacokinetic studies showed level A correlation (R(2) > .99) with 42.84% relative bioavailability compared to immediate release tablet of flurbiprofen. Excellent correlation achieved suggested that the in vivo performance of the AMCs could be accurately predicted from their in vitro release profile.

Optimization studies on design and evaluation of orodispersible pediatric formulation of indomethacin.

In the present study, the aim was to optimize an orodispersible formulation of indomethacin using a combined approach of subliming agent and superdisintegrant. The tablets were made by non-aqueous wet granulation technique with superdisintegrant incorporated both intragranularly and extragranularly. A 2(3) factorial design was used to investigate the effects amount of subliming agents namely camphor and ammonium bicarbonate and taste masking and soothening hydrophilic agent mannitol as independent variables and disintegration time and crushing strength as dependent responses. The volatilization time of eight hours at 50 degrees C was optimized by conducting solid-state kinetic studies of optimized formulations. Optimized orodispersible tablets were evaluated for wetting time, water absorption ratio, porosity and in vitro and in vivo disintegration tests. Results show that higher levels of camphor and mannitol and a lower level of ammonium bicarbonate is desirable for orodispersion. Scanning electron microscopy (SEM) revealed the porous surface morphology and kinetic digital images substantiated the orodispersible property. Differential Scanning Calorimetry (DSC) studies exhibited physiochemical compatibility between indomethacin and various excipients used in the tablet formulation. Stability studies carried out as per ICH Q(1) A guidelines suggested the stable formulations for the tested time period of 6 months. The systematic approach of using subliming and disintegrating agents helped in achieving a stable, optimized orodispersible formulation, which could be industrially viable.