Indian Male Subjects Research Articles

Modeling of thermoregulatory mechanisms of typical Indian male and female subjects under hot and cold stress

Modeling of thermoregulatory mechanisms of typical Indian male and female subjects under hot and cold stress

Protocol for Establishing the Norms of Total Tooth Material for Central Indian Population

Background: Appealing profile is dependent on constructive interrelation of craniofacial structure so as to establish systemic equilibrium . An esthetic profile may also be associated with single tooth or inter-arch malocclusion. To correct these malocclusions, the corresponding link of tooth material of upper and lower arch is the prerequisite to achieve functional stability of occlusion, structural balance and esthetic harmony.
 Objectives: To determine tooth size ratios for maxillary and mandibular dentition in Central Indian population.
 Methodology: The study sample comprised of 500 subjects (250 males and 250 females) aged between 12-20 years with all permanent first molar erupted will be obtained from the department. The mesio–distal width of all teeth anterior to first molar of maxillary and mandibular teeth from right to left side will be calculated
 Expected Results: Proof of sexual dimorphism was seen among Indian male subjects have greater mean values as compared to females. Statistically considerable differences were establish between Indian samples and Bolton Caucasian standards.
 Conclusion: The research presents, evidence that size of teeth are population specific. Mean values specific to peculiar population samples should be obtained in order to make treatment regime more precise as well as predictable.

Variation in interpeak latencies of auditory brainstem responses with age in male adults:An observation

Introduction and Aim: Aging of the auditory pathway is a complex phenomenon consisting of changes in the auditory processing along with a significant elevation of the hearing threshold. The aim of our study was to see the variation in interpeak latencies (IPLs) of Auditory Brainstem Responses (ABRs) with advancing age in males.
 
 Materials and Methods: It was an observational study conducted on 60 Indian male subjects aged between 20 and 80 years divided into three groups on the basis of age: Group 1: 20-40 years, Group 2: 41-60 years and Group 3: 61-80 years. Auditory threshold and ABRs were recorded and analysed for interpeak latencies (IPLs) – I-III,I-V and III-V in msec.The comparison of data between the groups was done using one – way ANOVA and Tukey Kramer multiple comparison test. The results were considered significantly different between the groups when ‘P value’ was ? 0.05.
 
 Results: It was found that there was no significant difference in the auditory threshold and interpeak latencies (IPLs) when comparison was made between the three groups.
 
 Conclusion: Hence we conclude thatage does not have any significant influence on neural conduction time of the auditory pathway which is represented by the IPLs in ABRs.

Quadrupled Hamstring Graft Diameter Adequacy in Anterior Cruciate Ligament Reconstruction Using Patient Anthropometry: A Prospective Cohort Study in Indian Males

Background and aimThe diameter of the graft used for the reconstruction of the anterior cruciate ligament (ACL) is an important determinant for the overall strength and future outcome of the operative procedure. Preoperative prediction of quadrupled hamstrings autograft (QHAG) diameter can prove to be of help in forecasting the need for augmentation or alternative grafts like quadriceps, bone-patellar tendon-bone autograft, and synthetic grafts. The relationship between the preoperatively assessed anthropometric parameters and the obtained quadrupled hamstrings graft diameter has not been extensively studied, especially in the population of Indian origin. This study aimed at investigating whether a correlation exists between the measured anthropometric parameters like age, weight, height, thigh circumference, and body mass index (BMI) and the intraoperatively obtained diameter of hamstring graft for ACL reconstruction in the study population of Indian male subjects.Study designA prospective cohort study conducted in a tertiary care center and teaching hospital in a district in central Uttar Pradesh, India.MethodsThe preoperative anthropometric data (age, height, weight, BMI, and thigh circumference of the injured side) of 73 Indian male subjects undergoing primary ACL reconstructive surgeries between May 2018 and August 2020 were prospectively collected, and their respective intraoperative QHAG diameters measured and recorded. Pearson’s correlation test was employed to determine the correlation between the preoperative demographic and anthropometric data and the obtained corresponding graft diameters. Simple linear regression was performed to obtain the graphical plots and determine the relationship between the dependent and independent variables. Of these, the variables showing significant association were subjected to stepwise linear regression to identify and exclude the confounder(s) and obtain the predicted equation.ResultsThe study comprised 73 male participants. The study participants' mean age was found to be 33.7 years, mean height was 173.1 cm, mean weight was 71.2 kg, mean BMI was 23.7 kg/m2, mean thigh circumference was 50.4 cm, and the obtained mean graft diameter was 8.0 mm. A strongly positive correlation was observed between height and the graft diameter (r=0.940, P=0.000) and thigh circumference and the graft diameter (r=0.769, P=0.000). In contrast, weight showed a moderately positive correlation with the graft diameter (r=0.514, P=0.000). A very weakly positive correlation was observed between the BMI of the subjects and the obtained graft diameters (r=0.236, P=0.045). However, no correlation was observed between the age and the final graft diameters (r=0.140, P=0.238). Subsequent linear regression analysis indicates that only height (R2=0.883, P=0.000; strong) and the thigh circumference (R2=0.591, P=0.000; moderate) share a significant predictive value for the obtained QHAG. Both height and thigh circumference together were good predictors for graft diameter as determined by multiple regression (F (2,70)=272.372, P<0.001), with an R2 of 0.886.ConclusionCertain anthropometric parameters depict a positive correlation with the QHAG diameter and can assist in preoperative planning, predicting the possible harvested graft diameter and the need for alternative grafts or augmentation during ACL reconstructive surgeries.

Fem Study to Analyze the Effect of Vibrations on Human Body Joints

Whenever a human body stands on a platform like a bus, train, etc then the waveform, frequency, amplitude, and duration due to vibrations can be changing and these variations produce some advantages in muscles and bone mineral density whereas high acceleration of platform viewed as dangerous. The reason behind this is the resonance of the human body that depends upon some factors: the seat surface material, the posture, vibration magnitude, and frequency, etc. In this study, modal and harmonic response analysis has been performed to calculate the natural frequencies of Indian human male subjects in standing posture conditions under un-damped and damped free vibration conditions. With the help of this, we are capable to know how these vibrations affect our muscles, bones, joints, etc. Joint studies of the human body help us to replace body joints in case of any serious injury or in emergency and multibody dynamics, modal analysis, and harmonic response play crucial roles in these effects. This study shows the vibration effects of transmissibility and stresses on the knee joints and neck joints of the human body. For this purpose, a revolute joint is separately designed and fixed at the location of joints in human subjects to understand the effect of these vibrations. The results are determined in this study are within the frequency range of 0-20 Hz.

PHARMACOKINETIC STUDY OF OLOPATADINE 10 MG EXTENDED RELEASE TABLET IN COMPARISON WITH OLOPATADINE 5 MG IMMEDIATE RELEASE TABLET IN INDIAN POPULATION

Objective: This study was designed to assess the pharmacokinetics of single dose of olopatadine hydrochloride 10 mg extended release (ER) tablet of Ranbaxy laboratories limited (two test formulations) with two doses of Allelock® 5 mg immediate release (IR) tablets of Kyowa Hakko Kogyo Co. Ltd. (reference formulation R), in healthy, adult, Indian male subjects under fed condition.&#x0D; Methods: Fifteen healthy male volunteers, 26.07±6.62 y in age and 57.17±6.68 kg in body weight, were divided into three groups and received either olopatadine hydrochloride 10 mg ER tablet or two doses of Allelock® 5 mg tablets in each period. Blood samples were taken at predetermined time points and plasma concentrations of olopatadine were monitored by liquid chromatography mass spectrometric (LCMS/MS). Pharmacokinetic (PK) parameters AUC0-t, AUC0-24, AUC0-∞, and Cmax were calculated for olopatadine using WinNonlin. A statistical analysis was performed on PK data using SAS system.&#x0D; Results: The ER formulations showed a similar AUC as compared to the IR formulation and there was no statistically significant difference in AUC of test formulation A and B and reference R. The ratios of AUC0-t, AUC0-24 and AUC0-∞ for A/R were 91.08, 94.90 and 91.32 and for B/R were 89.63, 93.95 and 89.63 respectively. The ER formulations reported a higher Cmax value as compared to IR formulation. The ratios of Cmax for A/R and B/R were 151.09 and 167.96 respectively. But these higher Cmax values did not pose any safety issue as there were no serious adverse events reported during the study.&#x0D; Conclusion: In conclusion, we can say that though the study drugs did not meet the bioequivalence criteria set by regulatory agencies, but this study gave an insight about PK properties of olopatadine extended release formulation and given an idea about effect of smoking on the PK profile of olopatadine which can be studied in future.

Variation in four limb blood pressure and central aortic pressure: An observational study on North Indian semi-urban males

Background: Measurement of ankle pressure along with measurement of both arm blood pressure (BP) can be helpful to for calculation of ankle-brachial index (ABI) and detection of early peripheral diseases among the patients. Non-invasive measurement of central aortic pressures is possible as considered as better marker for central hemodynamic situation. Studies on normal subjects are scant. Aim and Objectives: The present study was conducted to evaluate the difference of BP in four limbs obtained from simultaneous recording and evaluate the association with central aortic BP components and peripheral BP components in normal Indian healthy male subjects. Materials and Methods: The study was conducted in the Department of Physiology of Mayo Institute of Medical Sciences, Barabanki, with 25 healthy clinically normal subjects. Four limb BP was recorded and ABI and central aortic pressures were estimated using periscope arterial health and cardiovascular analysis system. Results: Ankle systolic BP (SBP) was significantly high for both sides. Inter-ankle mean arterial pressure difference found to be significantly associated with ABI. Central aortic systolic pressure was found to be lower than the peripheral SBP. Conclusion: Ankle BP measurement to be considered for early detection of peripheral arterial disease and should be performed routinely in hypertension clinics. Central aortic pressure gives a better picture for identifying the hypertensive state of the body.

Digit ratio and its implications on exercise capacity among non-athlete Indian male subjects

Background: The index (2D)-to-ring (4D) finger length ratio (2D:4D) commonly known as digit ratio has been the subject of recent interest and is thought to be related to sports ability, endurance running, disease susceptibility, and myocardial infarction at early age. Sexually dimorphic digit ratio is widely accepted as a putative marker for prenatal androgen exposure with men tends to have smaller ratio. Aim and Objective: The present study was conducted to evaluate any relation between digit ratio and exercise capacity in non-athlete Indian males. Materials and Methods: The study was conducted in the Department of Physiology of Mayo Institute of Medical Sciences, Barabanki, with 50 clinically normal healthy male volunteers. Finger lengths were measured directly using digital Vernier calipers. Exercise tolerance testing was done as per Bruce protocol with Allengers Gemini A-DX treadmill. Results: Two groups of higher (n = 26) and lower (n = 24) finger length ratio (right hand) were formed using median split. Significant difference observed (P = 0.0012, P < 0.05) for exercise capacity or percentage of predicated metabolic equivalents (METs) achieved having higher percentage by the low finger length ratio group. No significant difference observed for METs achieved for the groups. Correlation study shows a significant moderate negative correlation between digit ratio (right) and exercise capacity. Similar correlation was not significant for the left hand. Conclusion: These results suggest that a low digit ratio (right hand) is related to better aerobic capacity and exercise capacity in the males although the exact role of prenatal androgen exposure is unclear.

Association between the 2d:4d and cardiovascular risk factors: Body mass index, blood pressure and body fat

ObjectivesTo examine the relationship between the cardiovascular risk factors such as obesity as measured by Body mass index (BMI), body fat and blood pressure with the second to fourth digit ratio (2d:4d); a prenatal testosterone exposure marker. MethodsThe 2d:4d for both hands were measured for the Indian male subjects' (n = 1217). Subject's anthropometric parameters such as height, weight, skinfold thicknesses at various regions and blood pressure measurements were collected in a cross-sectional study with a convenient sampling approach. The association between digit ratio and the other variables were examined using analysis of variance, Pearson's correlation test and linear regression methods. ResultsThe study included 1193 subjects and all were males aged 19.69 ± 5.38 years (range 13 to 40 years). The subjects' body mass index (BMI) was 19.45 ± 3.82 and right and left hand 2d:4d were 0.958 ± 0.054, and 0.958 ± 0.061 respectively. The systolic blood pressure (SBP) and BMI significantly differed between the higher and lower half of right 2d:4d. The left hand 2d:4d was significantly correlated with SBP (r = 0.075, p = 0.028) and significantly differed between different hypertensive groups (p < 0.003, F = 3.552, df = 5). ConclusionThe study observed an association between 2d:4d with hypertension and BMI among young Indian population, emphasizing the effect of prenatal testosterone on late life cardiovascular risk factor.

Individual customization strategy accomplished by developing prototype of a laparoscopic forceps handle using additive manufacturing

PurposeLaparoscopic surgeons suffer because of discomfited body posture while performing surgery and experience discomfort owing to lack of customized surgical instruments. Accordingly, this paper aims to recommend an individual customization strategy by developing an ergonomically designed laparoscopic forceps handle and thereby increase the comfort of surgeons.Design/methodology/approachHand anthropometric parameters of 282 south Indian male subjects are used to customize the handle. uPrint and Objet260 Connex, which works based on fused deposition modeling and PolyJet, respectively, are used to fabricate the prototype of the handle. Design modifications include a pistol-type grip, the increased contact area between the hand and handle, and neutral wrist posture.FindingsErgonomic evaluation parameters such as grip, functionality, comfort and wrist posture using subjective ratings from laparoscopic surgeons were recorded and obtained average values of 4.1, 3.6, 4.1 and 4.1, respectively, based on a five-point ordinal scale. Additionally, stress analysis also confirms the safety of the handle based on von Mises stress criteria.Research limitations/implicationsAnthropometric data are limited to 282 subjects and subjective evaluation is conducted using a prototype, not the end-use product.Originality/valueEvaluation using subjective rating confirms the ascendancy of a modified handle over the existing handle in terms of assessed parameters. The proposed individual customization strategy can be applied for other industrial hand tools to enhance comfort.

Acyl ethanolamides in Diabetes and Diabetic Nephropathy: Novel targets from untargeted plasma metabolomic profiles of South Asian Indian men

The pathophysiology of diabetic nephropathy (DN) in type 2 diabetes (T2D) patients is minimally understood. We compared untargeted high-resolution accurate mass (HRAM) orbitrap-based plasma metabolomic profiles of 31 T2D-DN (with estimated glomerular filtration rate ≤80 mL/min/1.73 m2), 29 T2D and 30 normal glucose tolerance (NGT) Indian men. Of the 939 plasma metabolites that were differentially abundant amongst the NGT, T2D and T2D-DN (ANOVA, False Discovery Rate – FDR adjusted p-value < 0.05), 48 were associated with T2D irrespective of the renal function of the subjects. Acyl ethanolamides and acetylcholine were decreased while monoacylglycerols (MAGs) and cortisol were elevated in both T2D and T2D-DN. Sixteen metabolites, including amino acid metabolites Imidazolelactate and N-Acetylornithine, changed significantly between NGT, T2D and T2D-DN. 192 metabolites were specifically dysregulated in T2D-DN (ratio ≥2 or ≤0.5 between T2D-DN and T2D, similar abundance in NGT and T2D). These included increased levels of multiple acylcarnitine and amino acid metabolites. We observed a significant dysregulation of amino acid and fatty acid metabolism in South Asian Indian male T2D-DN subjects. Unique to this study, we report a reduction in acyl ethanolamide levels in both T2D and T2D-DN males. Those with dysregulation in acyl ethanolamides, which are endogenous agonists of GPR119, are likely to exhibit improved glycemic control with GPR119 agonists.

Association between second to fourth digit ratio and personality among Indian men.

To examine the relationship between the personality domains with the second to fourth digit ratio (2d:4d); a prenatal testosterone exposure marker. The 2d:4d for both hands was measured for the Indian male subjects' (n = 994). Ten-item personality inventory and displaced aggression questionnaire data were collected in a self-reported proforma in this cross sectional study with a convenient sampling approach. The personality traits, namely openness to new experiences, carelessness, and self-discipline were significantly differed between lower-half and higher-half of 2d:4d by median split. The right hand 2d:4d was positively correlated with open to new experiences and negatively correlated with disorganization, carelessness, and revenge planning. The left hand 2d:4d was positively correlated with aggression. On binary logistic regression, openness was positively associated while carelessness was negatively associated with the right hand 2d:4d and self-discipline trait was negatively associated with the left hand 2d:4d. This study affirmed the link between 2d:4d and domains of Big Five personality factors among Indian men and inverse relationship between 2d:4d and more "female" hands in the domains of disorganization, carelessness, and revenge planning even in men, emphasizing the effect of prenatal testosterone exposure on human personality.

High sensitive LC–MS/MS method for estimation of eluxadoline in human plasma and its application to pharmacokinetic study

A selective, sensitive and high throughput liquid chromatography – tandem mass spectrometry (LC–MS/MS) method was developed and validated for estimation of eluxadoline in human plasma. Plasma samples of analyte with internal standard (eluxadoline13CD3) were extracted using solid phase extraction on Orochem Panthera Deluxe cartridges. Chromatographic separation was performed on Ace Phenyl column (150 × 4.6 mm, 5 μm), using a mixture of buffer (2 mM ammonium acetate in 0.01% formic acid), acetonitrile and methanol (20:70:10, v/v/v) as mobile phase at a flow rate of 0.8 mL/min. The run time of analyte was 4.0 min. Tandem mass spectrometry, operating in positive ionization and multiple reaction monitoring modes was used for detection of analyte and internal standard. The method was established with a linear dynamic range of 25.0–5000 pg/mL for eluxadoline using 300 μL human plasma. The sample preparation procedure was consistent and reproducible (accuracy, 96.2–106.1%; precision (%CV), 0.8–6.6%), preventing the ex vivo hydrolysis of acyl glucuronide metabolite of eluxadoline to parent drug. The method was applied successfully to a clinical pharmacokinetic study in six healthy South Indian male subjects under fed conditions and the results were authenticated by incurred sample reanalysis.

Malaria vaccine candidate based on Duffy-binding protein elicits strain transcending functional antibodies in a Phase I trial

Reticulocyte invasion by Plasmodium vivax requires interaction of the Duffy-binding protein (PvDBP) with host Duffy antigen receptor for chemokines (DARCs). The binding domain of PvDBP maps to a cysteine-rich region referred to as region II (PvDBPII). Blocking this interaction offers a potential path to prevent P. vivax blood-stage growth and P. vivax malaria. This forms the rationale for development of a vaccine based on PvDBPII. Here we report results of a Phase I randomized trial to evaluate the safety and immunogenicity of recombinant PvDBPII formulated with glucopyranosyl lipid adjuvant-stable emulsion (GLA-SE). Thirty-six malaria-naive, healthy Indian male subjects aged 18–45 years were assigned into three cohorts corresponding to doses of 10, 25 and 50 µg of PvDBPII formulated with 5 µg of GLA-SE. Each cohort included nine PvDBPII/GLA-SE vaccinees and three hepatitis B control vaccine recipients. Each subject received the assigned vaccine intramuscularly on days 0, 28 and 56, and was followed up till day 180. No serious AE was reported and PvDBPII/GLA-SE was well-tolerated and safe. Analysis by ELISA showed that all three doses of PvDBPII elicited antigen-specific binding-inhibitory antibodies. The 50 µg dose elicited antibodies against PvDBPII that had the highest binding-inhibitory titres and were most persistent. Importantly, the antibody responses were strain transcending and blocked receptor binding of diverse PvDBP alleles. These results support further clinical development of PvDBPII/GLA-SE to evaluate efficacy against sporozoite or blood-stage challenge in controlled human malaria infection (CHMI) models and against natural P. vivax challenge in malaria endemic areas.

Determination of Bolton Norms for Indian Population Sample

Introduction: Tooth size discrepancy varies between different ethnic groups and races. Bolton’s tooth size norms were originally determined in Caucasian population.Objective: To determine tooth size ratios for maxillary and mandibular dentition in Telangana population of Indian sample and to compare the ratios with standard Bolton norms.Materials &amp; Method: The study sample comprised of 300 subjects (150 males and 150 females) aged between 14-25 years having Angle’s Class 1 molar relationship. Study models of all subjects were prepared and mesiodistal dimensions were measured to determine mean Bolton’s anterior ratio, overall ratio, over jet and overbite.Result: Evidence of sexual dimorphism was observed with Indian male subjects having greater mean values than the females. The determined mean for anterior tooth ratio was 80.88 ± 3.03%, overall tooth ratio 93.99 ± 3.11%, overjet 2.92 ± 0.62mm and overbite 2.96 ± 0.63mm. Statistically significant differences were found between Indian samples and Bolton Caucasian standards.Conclusion: The study provides evidence that tooth sizes are population specific. Mean values specific to particular population groups should be derived in order to make treatment planning more accurate and predictable.

Evaluation of diurnal variation in peak expiratory flow rates in healthy Indian adult male and female subjects

Background: Peak expiratory flow rate (PEFR) reflects the strength and condition of respiratory muscles and the degree of airflow limitation in large airways. PEFR shows hour-to-hour variation that follows a specific pattern, which has been identified in both asthmatics and healthy individuals. Adequate data were not available for the diurnal variation in normal individuals who are students in professional courses and lead a sedentary lifestyle. Hence, this study was undertaken to study the diurnal variation in PEFRs in healthy adult male and female subjects in South India. Materials and Methods: PEFR was recorded in 50 healthy adult male and 50 healthy adult female students aged 18-23 years who were enrolled in professional courses [e.g. Bachelor of Medicine (MBBS), Bachelor of Dental Surgery (BDS), Nursing, and Master of Science (M.Sc.)]. Mini-Wright peak flow meter was used to measure the PEFR. The PEFRs were recorded at 7-8 AM, 10-11 AM, 1-2 PM, 4-5 PM, and 7-8 PM for 2 consecutive days. Results: On analysis of the PEFR records of individual subjects, it was seen that there was an overall dip in the morning at 7-8 AM PEFR, which increased in the daytime, peaking in the afternoon at 4-5 PM and eventually decreased in the night. The subjects did not show the peak PEFR values at the same time point, 16% of the subjects had a rise in PEFR in the early morning, afternoon (1-2 PM) peak was observed in 22% of subjects, and evening (4-5 PM) peak was observed in 36% of subjects. Only 2% of subjects showed a peak in the night time (7-8 PM) PEFR values. Conclusion: This study provided the preliminary reference data of diurnal variation of PEFR in healthy adults. There is a variation in the PEFR recorded during different time points of the day; hence, in order to compare the PEFR between individuals it is advisable to record the PEFR at the same time point. The difference in diurnal variation may be due to the difference in the waking up time between the male and the female subjects as the peak PEFR is generally seen at the midtime of the entire duration when the subject is awake.

Bioequivalence of Two Different Nicotine Chewing Gum Formulations of Two Different Strengths (2 mg and 4 mg) in Indian Healthy Adult Human Male Smoker Subjects

Nicotine Mint Flavored Chewing Gums are used to aid smokers wishing to quit or reduce prior to quitting. The aim of these two studies was to determine the bioequivalence of two test and two reference formulations of Nicotine 2 mg and 4 mg Mint Flavored Chewing Gum. Both of these two studies were single dose, randomized, 2-period, 2‑sequence, laboratory-blinded, crossover design conducted in two different set of 54 healthy adult Indian male subjects each under fasting conditions with a washout period of 8 days (for 2 mg study) and 9 days (for 4 mg study). Study formulations were administered after a 10-hour overnight fast. Blood samples for pharmacokinetic profiling were taken post-dose up to 24 hours. Safety was evaluated through the assessment of adverse events, and laboratory tests. Plasma concentrations of Nicotine were determined with a validated LC-MS/MS method. Bioequivalence between the products was determined by calculating 90% confidence intervals (90% CI) for the ratio of Cmax and AUC0-t values for the test and reference products, using logarithmic transformed data. The 90% CI of Nicotine were 93.71-113.45, 89.95-112.68 and 92.90-115.98 for Cmax, AUC0-t and AUC0-∞ respectively for Nicotine 2 mg Mint Flavored Chewing Gum study. The 90% CI of Nicotine were 88.68-102.76, 91.48-109.00 and 91.14-111.66 for Cmax, AUC0-t and AUC0-∞ respectively for Nicotine 4 mg Mint Flavored Chewing Gum study. Since the 90% CI for Cmax and AUC0-t were within the 80-125% interval, it was concluded that the two test and two reference formulations of Nicotine 2 mg and 4 mg Mint Flavored Chewing Gum are bioequivalent in their rate and extent of absorption.

LC-MS/MS assay for the determination of lurasidone and its active metabolite, ID-14283 in human plasma and its application to a clinical pharmacokinetic study.

The authors proposed a sensitive, selective and rapid liquid chromatography-tandem mass spectrometric (LC-MS/MS) assay procedure for the quantification of lurasidone and its active metabolite, i.e. ID-14283 in human plasma simultaneously using corresponding isotope labeled compounds as internal standards as per regulatory guidelines. After liquid-liquid extraction with tert-butyl methyl ether, the analytes were chromatographed on a C18 column using an optimized mobile phase composed of 5 mm ammonium acetate (pH 5.0) and acetonitrile (15:85, v/v) and delivered at a flow rate of 1.00 mL/min. The assay exhibits excellent linearity in the concentration ranges of 0.25-100 and 0.10-14.1 ng/mL for lurasidone and ID-14283, respectively. The precision and accuracy results over five concentration levels in four different batches were well within the acceptance limits. Lurasidone and ID-14283 were found to be stable in battery of stability studies. The method was rapid with the chromatographic run time 2.5 min, which made it possible to analyze 300 samples in a single day. Additionally, this method was successfully used to estimate the in vivo plasma concentrations of lurasidone and ID-14283 obtained from a pharmacokinetic study in south Indian male subjects and the results were authenticated by conducting incurred samples reanalysis. Copyright © 2015 John Wiley & Sons, Ltd.

Radiographic analysis of the axial alignment of the lower extremity in Indian adult males

BackgroundTo evaluate data on the normal axial alignment of the lower extremity in Indian adults and its relevance in knee arthroplasty. MethodsThe axial alignment of the lower extremity in one hundred young male adults was measured on the weight bearing scanogram of the entire lower limb under standardized conditions. The angles measured were – neck shaft angle, lateral distal femoral angle, medial proximal tibial angle, tibiofemoral angle and valgus angle. ResultsMedial inclination of the tibial plateau in our subjects was 4°; this was greater than reported for American subjects but less than that for Chinese. It was significantly noted that valgus angle was 6.2° at an average with the range of 5–7°. ConclusionsAxial alignment of lower extremity differs in various ethnic groups. Indian male subjects have more varus alignment of knee and significant higher medial inclination of tibia plateau than white male subjects (p value<0.05). Four degrees of external rotation of the femoral component instead of commonly used 3° is necessary, while performing total knee arthroplasty in Indian male subjects.

Systematic evaluation of matrix effect and cross-talk-free method for simultaneous determination of zolmitriptan and N-desmethyl zolmitriptan in human plasma: a sensitive LC-MS/MS method validation and its application to a clinical pharmacokinetic study.

The objective of the present work was to carry out systematic evaluation to eliminate matrix effect owing to plasma phospholipids as observed during sample preparation and to develop a cross-talk-free sensitive, selective and rapid bioanalytical method for the simultaneous determination of zolmitriptan (ZT) and N-desmethyl zolmitriptan (DZT) in human plasma by liquid chromatography-tandem mass spectrometry using naratriptan as internal standard (IS). The analytes and IS were quantitatively extracted from 200 μL human plasma by solid phase extraction. No cross-talk was found between ZT and DZT having identical product ions. Quantitation was performed on a triple quadrupole mass spectrometer employing electrospray ionization technique, operating in multiple reaction monitoring and positive ion mode. The total chromatographic run time was 2.5 min. The method was fully validated for sensitivity, selectivity, specificity, linearity, accuracy, precision, recovery, matrix effect, dilution integrity and stability studies. The method was validated over a dynamic concentration range of 0.1-15 ng/mL for ZT and DZT. The method was successfully applied to a bioequivalence study of 2.5 mg ZT tablet formulation in 18 healthy Indian male subjects under fasting conditions. Assay reproducibility was assessed by reanalysis of 62 incurred samples.