Effect of SGLT in Type 2 Diabetes and Gastric Bypass Surgery - A Narrative Review

Body fat is regulated by a complex neuroendocrine system,making it difficult to maintain weight loss achieved via caloricrestriction. Bariatric surgery produces greater weight lossand weight loss that is more durable than caloric restriction,and therefore is currently the most effective therapy forobesity. Sodium-glucose-co-transporter inhibitors areglucose lowering drugs that reduces plasma glucose levelsby inhibiting glucose and sodium reabsorption in the kidneys,resulting in glycosuria.Sleeve gastrectomy is one such bariatric surgical procedurethat involves the creation of a reduced stomach lumen alongthe lesser curvature of the stomach through the removal ofgastric tissues along the greater curvature from the fundusto the antrum. Stomach capacity is typically reduced 80%or more, and the intestine remains intact. This procedureproduces dramatic weight loss in humans and in rodents. Infact, recent reports indicate that its efficacy is close to that ofthe more common Roux-en Y gastric bypass.There are many diverse factors on which operative mortalityof bariatric surgery depends such as facility related, surgeonrelated, followed by patient and procedure-related. Tominimize operative mortality, specific factors were consideredfor the specific patients. As a result, to treat type 2 diabetes inassociation with obesity, slightly obese patients or overweightpatients were treated with conventional bariatric proceduresworldwide. For the management of morbidity obese diabeticpatients, there is no single or standard procedure

Bone Mineral Density in patients with Chronic low back pain

Objective: To determine mean bone mineral density in patients with chronic low back pain presenting at Armed Forces Institute of Rehabilitation Medicine Rawalpindi based on dual energy x-ray absorptiometry studies

Study Design: Cross sectional study

Place and Duration of Study: Armed Forces Institute of Rehabilitation Medicine [AFIRM], Rawalpindi from Apr 2015 to Mar 2016

Patients and Methods: Two hundred and forty patients having low back pain of more than 6 months duration fulfilling the inclusion criteria were included both from indoor and outdoor departments through non-probability consecutive sampling. Bone mineral density was measured at lumbar spine by dual energy x-ray absorptiometry studies by the same technical staff using the same equipment. A written informed consent was taken from each patient. Data were collected and recorded on specialized proforma by the principal investigator

Results: Spine BMD on DXA scan ranged from 0.90 to 0.98 g/cm2 with a mean of 0.95 +/- 0.02 as shown in. When stratified, the mean BMD decreased significantly with increasing age and severity of LBP; 20-30 years vs. 31-40 years [0.95 +/- 0.01 vs. 0.92 +/- 0.02; p=0.001]. However, there was no significant difference in mean BMD across genders; male vs. female [0.94 +/- 0.01 vs. 0.94 +/- 0.02; p=0.680]. Similarly there was no significant difference in mean BMD across various durations of low back pain; 7-10 vs. 11-14 months [0.94 +/- 0.03 vs. 0.93 +/- 0.01; p=0.617]

Conclusion: The mean bone mineral density at spine was found to be lower in patients with chronic low back pain. It was significantly lower in older patients and those with severe low back pain. However, it didn't change significantly with various durations of low back pain or gender

Development and evaluation of eudragit based microparticles of dexibuprofen for site specific drug release

The main purpose of work was to formulate dexibuprofen loaded eudragit L-100 micro particles to acquire site specific delivery of dexibuprofen. Micro particles were formulated by an emulsion solvent evaporation method. Four formulations F1, F2, F3 and F4 having drug to polymer ratio 1:1, 1:2, 1:3 and 1:4, respectively were prepared and characterized. The rheological properties manifested that micro particles were worthy for further pharmaceutical exploitation. No notable drug polymer interaction was perceived in FT-IR spectroscopy. SEM micrographs showed rough surface of micro particles. The resulting micro particles had high entrapment efficiency greater than 70%. The in vitro dexibuprofen release at pH 1.2 exhibited poor drug release with less than 21% while at pH 6.8, 60% of the dexibuprofen was released up till 8th hour. The dexibuprofen release was modified by altering polymer concentration in the formulation. The subsequent micro particles were found to be best fit with zero-order release model. Micro particles were efficiently formulated with a focus to release the drug majorly in small intestine. With increase of polymer concentration enhanced entrapment efficiency and decelerated dexibuprofen release from the micro particles has been achieved. In vitro dexibuprofen studies verified the gastro-resistant property of micro particles thus qualify site specific release in gastrointestinal tract

study of hygienic practices in secondary level students of the Quetta City

Objective: To investigate the standards of personal hygiene in secondary level students

Study Design: Observational / descriptive / cross sectional study

Place and duration of study: This study was conducted at Government Sardar Essa Khan Girls High School, Quetta from July 2014 to December 2014

Materials and Methods: The study was conducted on grade 7[th] and 8[th] students of Government Girls High School Quetta with the help of questionnaire. Health status of students was also examined by performing physical examination

Results: Amongst the target population 40.31% students were 11 to 13 years old, 57.65% were 13-16 years old while 2.04% students belonged to the 16.1 to 19 age group. Parents of the majority of the participants were literate. Family income of 52.65% students was above Rs. 15000/month. All the students had closed sewage system and community water supply in their houses. More than 80% of students were found neat, clean and healthy according to the criteria of health score designed for this study

Conclusion: This study indicates satisfactory personal hygienic conditions amongst target students but still there was a room for improvement. However, awareness campaigns should be conducted in schools to increase understanding about good hygiene practices

Pharmacokinetic evaluation of anticancer drugs in Hodgkin's lymphoma patients after their simultaneous administration

A pharmacokinetic study of anticancer drugs was carried out in 18 Hodgkin's lymphoma male patients. The anticancer drugs were administered to the patient by a standard procedure and a validated HPLC method was used for plasma concentration determination. Maximum plasma concentration [C[max]] of Adriamycin, Bleomycin, Vinblastine and Dacarbazine [ABVD] were 7.71, 4.32, 7.95 and 6.51 micro g/ml respectively. Adriamycin and Dacarbazine exhibited longer T[max] compared to Bleomycin and Vinblastine. Area under the curve values of ABVD were 118.30, 82.11, 245.54 and 86.62 micro g/ml h. The elimination rate constant of Dacarbazine was highest. Vinblastine exhibited highest half-life and mean residence time. Clearances of ABVD were 346.69, 2499.44, 45.90 and 5800.05ml/h. The apparent volume of distribution was highest for Dacarbazine and lowest for Vinblastine. The pharmacokinetic parameters can be utilized for monitoring of plasma concentrations, therapeutic drug monitoring and dosage adjustments to optimize anticancer efficacy in patients of Hodgkin's lymphoma

Safe electrosurgery use: knowledge, attitudes and practices of surgical trainees

To determine the knowledge, attitudes and practices of general surgical trainees regarding safe use of diathermy. In this cross-sectional Survey, 47 surgical trainees of the Civil Hospital Karachi, comprising PGY 1 through 4, were interviewed by questionnaires made up of five close-ended and three open-ended items. Majority of the trainees belonged to the first two years of training. More than 80% had no formal training in diathermy use. Most of them were found lacking in core knowledge and evidence-based practice of electrosurgery. There was a high level of ignorance regarding current and established principles of diathermy use among surgical trainees at the Civil Hospital Karachi

Frequency and the related socio-demographic and clinical factors of phantom limb pain in traumatic amputees presenting at a tertiary care rehabilitation setup

Objective: To find out the frequency of phantom limb pain [PLP] in a sample of Pakistani amputee population presenting with amputation due to trauma and to investigate its relationship with different sociodemographic and clinical factors

Study Design: A cross-sectional descriptive study

Place and Duration of Study: Armed Forces Institute of Rehabilitation Medicine, Rawalpindi from August 2010 to October 2013

Material and Methods: Through non-probability purposive sampling, patients of both genders and all ages having a traumatic etiology of amputation were sampled from the outdoor amputee clinic and the indoor amputee ward. Patients having diabetes mellitus, polyneuropathy, memory loss, cognitive deficits and established history of psychiatric disorders were excluded. Through face to face semi structured interviews, information was obtained about presence of PLP, gender, location [urban or rural], ethnicity based on Pakistani provinces [Punjab, Sindh, Khyber Pakhtunkhwa, Balochistan, Azad Jammu and Kashmir], monthly income in Pakistani Rupees [PKR] [<10,000, 10,000 - <50,000 and >50,000], level of education [grade <5, grade 5 - 10, and grade >10], level of amputation and cause of trauma [fall from height, motor vehicle accident, blast injury, bullet injury or others]

Results: Out of 268 patients [mean age 28 +/- 6 years], 266 [99.3%] were male and 2 [0.7%] were female. Majority [79.1%] were rural based, Punjabis [44.8%], had a monthly income <10,000 PKR [85.4%], education from grade 5 - 10 [80.2%] and a lower limb amputation [86.9%]. The commonest cause was blast injuries [72.8%]. PLP was present in 42.5% [n=114] of the individuals and it was not significantly related to gender, living location, ethnicity based on Pakistani provinces, level of education, monthly income, cause of traumatic amputation and level of amputation

Conclusion: PLP was found in 42.5% of our sample of Pakistani traumatic amputees. The frequency was not related to gender, monthly income, ethnicity based on provinces, education, rural or urban based living and etiology or level of amputation

Pattern of acid base abnormalities in critically ill patients

To find out the pattern of acid base abnormalities in critically ill patients in a tertiary care health Sacility. A descriptive study. The study was carried out in the department of pathology, Combined Military Hospital Kharian from January 2013 to June 2013. Two hundred and fifty patients suffering from various diseases and presenting with exacerbation of their clinical conditions were studied. These patients were hospitalized and managed in acute care units of the hospital. Arterial blood gases were analysed to detect acid base status and their correlation with their clinical condition. Concomitant analysis of electrolytes was carried out. Tests related to concurrent illnesses e.g. renal and liver function tests, cardiac enzymes and plasma glucose were assayed by routine end point and kinetic methods. Standard reference materials were used to ensure internal quantify control of analyses. Two hundred and fifteen patients out of 250 studied suffered from acid base disorders. Gender distribution showed a higher percentage of male patients and the mean age was 70.5 +/- 17.4 years. Double acid base disorders were the commonest disorders [34%] followed by metabolic acidosis [30%]. Anion gap was calculated to further stratify metabolic acidosis and cases of diabetic ketoacidosis were the commonest in this category [47%]. Other simpie acid base disorders were relatively less frequent. Delta bicarbonate was calculated to unmask the superimposition of respiratory alkalosis or acidosis with metabolic acidosis and metabolic alkalosis. Though triple acid base disorders were noted in a small percentage of cases [05%], but n7ere found to be the most complicated and challenging. Mixed acid base disorders were associated with high mortality. A large number of critically ill patients manifested acid base abnormalities over the full spectrum of these disorders. Mixed acid base disorders were commonest and were bad prognostic indicators, most often associated with high mortality. This warrants a high index of suspicion, a thorough clinical assessment of patient and a structured approach to analyze the relevant laboratory data in the given clinical setting. Only with prompt detection of an acid base disorder, clinician can formulate an appropriate management strategy for the patient

Comparison of efficacy of oral and intramuscular iron supplementation for treatment of iron deficiency anemia in children

To compare the efficacy of oral iron preparation with intramuscular iron sorbitol in treatment of iron deficiency anemia in children. Randomized controlled trial. Paediatric department of Combined Military Hospital Kharian, Pakistan, from October 2011 to March 2013. In total 200 anemic chldren from 6 months to 5 years of age were included. Cut off value for Hb was < 8 gm/dl. Patients were divided into two groups, each of 100, randomly. Group A received oral sodium feredetate [iron edetate] and group B received intramuscular iron sorbitol. Rise in Hb > 10 gm/dl was kept as the desired value. Maximum duration of treatment planned was 12 weeks for group A and 2 weeks for group B. Laboratory parameters such as Hb%, mean corpuscular volume [MCV], retic count and serum ferritin level were used to detect the responses in both groups at one week, two weeks, four weeks and twelve weeks of treatment. Among 200 patients, male and female distribution was 45% and 55% respectively. Desired rise in Hb in group B was achieved much earlier i.e. at two weeks as compared to group A. Progressive rise in laboratory parameters was observed but this rise was more evident in group B as compared to group A. After one week treatment in group A, rise in retic count, Hb, ferritin and MCV was 0.759 +/- 0.318, 0.814 +/- 0.387, 0.47 +/- 0.154 and 4.28 +/- 2.468 respectively. But rise in these values in group B was 2.235 +/- 0.632, 2.335 +/- 0.135, 6.31 +/- 1.123 and 12.11 +/- 0.414 respectively. Same persistent different trend was observed at 2 and 4 weeks. After 12 weeks treatment in group A, rise in retic count, Hb, ferritin and MCV was 1.044 +/- 0.222, 5.204 +/- 0.134, 17.39 +/- 2.551 and 16.61 +/- 1.214 respectively but rise in these laboratory indices in group B was 0.551 +/- 0.261, 6.097 +/- 0.21, 42.49 +/- 2.768 and 20.68 +/- 2.233 respectively. The comparison of hematological indices after 12 weeks in A and B groups show sigruficant differences. All these parameters improved in both groups but improvement in group B was drastically more prominent when compared with group A [p-value < 0.05]. Intramuscular iron sorbitol therapy is an alternative and comparatively better treatment option as compared to oral iron therapy, sodium feredetate, in regards of treatment duration and earlier rise in the laboratory indices

Unani concept of jaundice and its management

Jaundice is a disease, which is characterized by yellow staining of the skin and sclera by abnormally high blood levels of the bile pigment bilirubin. The yellowing extends to other tissues and body fluids. Bilirubin, a tetrapyrrole pigment, is a brokendown product of heme [ferroprotoporphyrin IX]. About 70 to 80% of the 250 to 300 mg of bilirubin produced each day is derived from the breakdown of hemoglobin in senescent red blood cells. The remainder comes from prematurely destroyed erythroid cells in bone marrow and from the turnover of hemoproteins such as myoglobin and crytochromes found in tissues throughout the body

The philosophy of Unani system of medicine is based on the humoral theory. The theory was central theme to the teachings of Hippocrates and Galen and it became the dominant theory in Europe for many centuries. As per the Unani system of medicine, the cause of jaundice is the accumulation of yellow or black humours in the cutaneous tissue and its nearby tissues. Based upon the nature of discoloration jaundice is classified into two types: Yellow Jaundice and Black Jaundice

In the allopathic system there lack of effective drugs for jaundice. Some hepatoprotective drugs are available but many side effects are associated with them due to their chemical composition. In Unani system of medicine, this disease can be cured with completely natural and noninvasive methods

Present study was conducted in MIJ Tibbia Unani Medical College, Mumbai in the year 2007. Nine patients suffering from sciatica due to lumbar spine osteoarthritis were selected. Their clinical examinations were conducted to diagnose the sciatica. The X-ray of the lumbar spine was also taken to confirm the diagnosis of osteoarthritis of lumbar spines. Massage with Roghan-e-Surkh on the lower back and affected lower limb for 8-10 minutes daily for 14 days caused a significant reduction in the symptoms and signs of sciatica after the completion of study

Theft of Unani formulations for the treatment of various diseases is not new but it is a matter of concern since last couple of decades. However, information regarding Unani Medicine exists in Arabic, Urdu, Persian and other regional languages. The examiners of different national/ international patent offices are unable to understand this information as prior art, before granting patents due to language barrier

Some of the examples of case studies of misappropriation of Pistacia lentiscus Linn is discussed in which the indication of Pistacia lentiscus Linn i.e. anti-inflammatory [mentioned in Unani classical texts] has been claimed for wrong patent

Group B streptococcus neonatal meningitis-less common cause of neonatal meningitis in pakistan and disparity between csf culture and other parameters

Neonatal bacterial meningitis is a devastating illness with significant mortality and morbidity. Incidence and etiology of neonatal bacterial sepsis and meningitis varies among developed and developing countries. We are reporting a case of 6 days old neonate who presented with fever, refusal to take feed and then followed by an episode of seizure activity. Laboratory parameters for complete sepsis screening including cerebrospinal fluid [CSF] and metabolic screening were absolutely normal for his age, but CSF culture revealed growth of group B Streptococcus [Streptococcus agalactiae] Patient was treated successfully without any morbid sequel

Preparation and in vitro evaluation of Nystatin micro emulsion based gel

Nystatin is a polyene antimycotic obtained from Streptomyces noursei used in the treatment of topical and transdermal fungal infection. Nystatin is nearly insoluble in water [<0.1] and it is amphoteric in nature. The aim of the present study was to design and develop Nystatin micro emulsion based gel for efficient delivery of drug to the skin by water titration method. The Pseudoternary phase diagrams 1:2, 1:1 and 2:1 were constructed by water titration method. Micro emulsion based gel was prepared by using oleic acid, Tween 20, propylene glycol as an oil phase, surfactant and cosurfactant respectively. Cabopol 940 was used as a gelling agent. In vitro evaluation of micro emulsion based gel was done for pH, Viscosity, spreadability and droplet size. Micro emulsion based gel showed greater antifungal activity against Candida albicansas compared to control formulations. In vitro drug release studies were conducted for micro emulsion based gel and control formulation using Franz diffusion cell. Drug penetration through synthetic skin followed Zero order model as the values for R[2] higher in case of zero order equation. The optimized micro emulsion based gel was found to be stable and showed no physical changes when exposed to different temperatures for a period of 4 week. The results indicated that the micro emulsion based gel system studied would be a promising tool for enhancing the percutaneous delivery of Nystatin

Pharmacokinetic studies of metformin and glibenclamide in normal human volunteers

The study was aimed to evaluate various pharmacokinetic parameters of a commercially available fixed dose combination of oral antidiabetics [Metformin/Glibenclamide 500/5mg tablets] in plasma sample of normal healthy adult male volunteers by applying an accurate, selective, and reproducible HPLC-UV analytical method for quantification of Metformin HCL and Glibenclamide simultaneously in a single chromatographic run. Previously no HPLC-UV analytical method for simultaneous estimation of Metformin/Glibenclamide has been reported in Pakistan. The human plasma samples were evaluated by using an isocratic High Performance Liquid Chromatography [HPLC] system of Sykam consisted of a pump with a column of Thermo Electron Corporation USA [ODS hypersil C[18] 4.6 mm x 250 mm], a UV-detector with data processing Clarity software. The mobile phase of 0.040M Potassium dihydrogen phosphate containing 0.25mL/L triethylamine at pH 3.5 [adjusted with 1:1 phosphoric acid] and acetonitrile [465: 535v/v] was delivered with injection volume of 100microL at flow rate of 1 mL/min at 25degreeC temperature. The detection was performed at lamda[max]230 nm. By applying this method, important pharmacokinetic parameters C[max], T[max], AUC[0-infinity], AUMC[0-infinity], t[1/2], Ke, MRT, V[d] and Cl[T] are calculated. Maximum plasma concentrations C[max] was 131.856 +/- 8.050ng/ml for Glibenclamide [Mean +/- SEM] and 511.106 +/- 12.675 ng/ml for Metformin HCl [Mean +/- SEM].

Malaria; assessment of haematological changes

To see the effects of malaria infection on platelet count and haemoglobin in children suffering from malaria. Descriptive study. CMH Okara and CMH Pano Aqil Cantt. July 2008 to June 2012. Children admitted with fever of less than seven days duration who had positive smear for malaria parasite were included in the study. After detailed history and thorough examination, patients were investigated to find out the cause of fever. All the patients with localizing cause for fever and history of drug intake were excluded. All patients were investigated with complete blood counts and serial peripheral smears for malaria parasite. Peripheral blood smear examination for malarial parasite was taken as gold standard for the diagnosis of malaria. Cut off 9 value for low hemoglobin [anemia] was taken as 10gm/dl and platelet count of less than 150x10[9]/L, was used to define thrombocytopenia. Patients with thrombocytopenia were divided in to three categories. Mild thrombocytopenia was defined as patients with platelet count of <50x10[9]/L to >150x10[9]/L, moderate thrombocytopenia included patients with platelet counts of <20x10[9]/L to >50x10[9]/L and severe thrombocytopenia consisted of patients with platelet counts of <20x10[9]/L. A total of one hundred and fourteen smear positive patients were analyzed, out of which 93% had low and 7% had normal platelet count. 95% had Vivax and only 5% had Falciparum malaria. Mean platelet count was 87x10[9]/L. Mean platelet count in Falciparum was 42x10[9]/L whereas it was 88 x10[9]/L in Vivax malaria. Sixty two [54%] patients had anaemia. Mean haemoglobin was 9.54gm/dl. Mean Hb in Falciparum malaria was 7.5gm/dl and in Vivax it was 9.6gm/dl. Higher frequency of mild to moderate thrombocytopenia and anaemia was observed in hospitalized children suffering from malaria. Plasmodium Vivax was found to be the most common species

Formulation development and in vitro evaluation of theophylline microcapsules

The study was aimed to investigate microencapsulation of theophylline using different ratios of eudragit S 100 as wall material by the emulsion solvent evaporation technique. The release profiles, effect of stirring speed and different pH of dissolution medium on release profiles and stability were also studied. Various formulations of microcapsules were compressed in to tablets. In vitro dissolution studies indicated that the rate of drug release was reduced with an increase in the amount of Eudragit S 100. Moreover, the release data of various formulations were fitted to Zero order, First order, Higuchi, Hixson Crowell and Korsmeyer Peppas kinetic models. It was observed that the release of drug from all the formulations followed Higuchi's kinetic model as its value of coefficient of determination is greater than that of others. The release profiles of the test formulation in distilled water and various pH media were compared and decreased release rate was seen at lower pH i.e. pH 1.0. Slight or no change was apparent in the release rate at higher stirring speed compared to lower stirring speed. No significant changes were also observed in the drug release profiles of test tablets stored at different temperatures. Test tablet [F2] was found to produce similar and sustainable release rate compared to commercial product, Quibron-T/SR tablet on the basis of their T[70%]. Similarly, f[2] values of reference versus F2 is 66.98 which show less difference between these two as compared to the comparison of reference with F1 and F3

Lipid lowering effect of Cinnamomum zeylanicum in hyperlipidaemic albino rabbits

The purpose of the present study was to investigate the lipid lowering effect of Cinnamomum zeylanicum [Cinnamon] in hyperlipidaemic albino rabbits. For this purpose, forty eight albino rabbits were randomly divided into eight equal groups; untreated control on normal routine feed, untreated control on butter and cholesterol, treated control on synthetic cholesterol lowering drug simvastatin [Tablet survive[R] 20 mg], three treated groups on three respective doses of C. zeylanicum bark powder and two treated groups on water and methanol extracts of C. zeylanicum bark powder. Butter ad lib and cholesterol powder 500 mg/kg body weight were used to induce experimental hyperlipidaemia in all groups except untreated control group. The results suggested that C. zeylanicum bark powder at the rate of 0.50 g/kg, 0.75 g/kg and methanol extract equivalent to 0.75 g/kg powder produced respective percent reductions in total lipids by 45, 49 and 64; triglycerides by 38, 53 and 60; total cholesterol by 53, 64 and 69 and LDL-cholesterol by 50, 59 and 62. However, at these dosage levels HDL-cholesterol showed respective percent increase of 42, 48 and 53. Nonetheless, C. zeylanicum bark powder at the level of 0.25 g/kg and C. zeylanicum extract in water could not significantly reduce lipid profile indicators. Based on these studies, it can safely be said that C. zeylanicum bark powder methanol extract equivalent to 0.75 g/kg bark powder and simvastatin [0.6 mg/kg b. wt.] were equieffective in treating hyperlipidaemia

Study of pharmacokinetics and comparative bioavailability of nefopam 30 mg tablets in twelve fasting healthy Pakistani male young subjects: single-dose, randomized, two-period, two-treatment and two-way cross-over design

To study the pharmacokinetics and comparative bioavailability of Nefopam tablets [Acupan[R]]. Experimentation of this study was based on a single-dose, two-sequence, cross-over randomized design using 12 fasting healthy Pakistani male young subjects. This validated LC/MS method was applied to a pharmacokinetic and bioavailability study in 12 fasting healthy Pakistani male subjects from the blood samples taken up to 24 h after an oral dose of one tablet of 30 mg nefopam in a double-blind, randomized, cross-over design. The mean maximum plasma concentration [C[max]] for the reference formulation was 60.71 +/- 2.36 ng/ml [ +/- SEM] and for test formulation 60.46 +/- 1.30 ng/ml [ +/- SEM]. The mean time to reach maximum plasma concentration [T[max]] values of reference and test formulations was 1.63 +/- 0.13 h [ +/- SEM] and 1.83 +/- 0.07 h [ +/- SEM], respectively. The mean +/- SEM values of AUC[0-infinity] for the reference and test formulations were 293.01 +/- 16.09 ngúh/ml and 307.53 +/- 8.99 ngúh/ml, respectively. The results showed that both formulations possessed almost the same relative bioavailability and pharmacokinetic parameters

Comparison of bioavailability and pharmacokinetics of diclofenac sodium and diclofenac potassium in normal and alloxan-diabetic rabbits

The present study was undertaken to compare the bioavailability and pharmacokinetic parameters of diclofenac sodium and diclofenac potassium in normal and experimentally induced diabetic state in 24 rabbits using a validated reversed phase HPLC method with a washout period of one week. Biochemical and physiological parameters were measured in normal and diabetic rabbits. Primary kinetic parameters i.e. AUC[0-infinity], C[max], t[max] and other disposition kinetics were determined with non-compartmental procedure. A paired t-test for normal and alloxan treated rabbits revealed a significant decrease in packed cell volume and a significant increase in glucose, total lipids, total proteins, albumin and globulin were observed in diabetic [metabolically altered] rabbits. Plasma concentration of diclofenac [sodium] and diclofenac [potassium] decreased in diabetic condition. Significantly high concentration of diclofenac [potassium] was observed in normal and diabetic conditions as compared to diclofenac [sodium]. The variation in bioavailability and disposition of diclofenac sodium and diclofenac potassium in diabetic state will require adjustment of the dosage regimen prescribed for diabetics in clinical setting

Bioequivalence evaluation of norfloxacin tablets based on in vitro - in vivo correlation

Present study was designed to establish in-vitro and in-vivo correlation [IVIVC] of two immediate release tablet formulations of 400mg Norfloxacin [Drug A as test and Drug B as reference]. Dissolution study was conducted in 0.1 N HC1 using USP apparatus II. In-vivo evaluation was carried out in 18 healthy humans according to a single dose, two-sequence, and cross-over randomized with a wash-out period of one week. After dosing, serial blood samples were collected for a period of 10 hours. Plasma harvested from blood, was analyzed for norfloxacin by a sensitive, reproducible and accurate HPLC method. Various pharmacokinetic parameters were determined from plasma concentrations for both the formulations. Non-significant difference was found for test/reference ratio of these parameters and the value of F was found to be 0.99 which is in good agreement with the limits given in PDA and WHO guidelines for such parameters. Difference factor [f[1]], similarity factor [f[2]] and level A IVIVC were evaluated showing that drug A is bioequivalent to drug B