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Fulltext An omental fibroma resembling a testicular tumour but presented as an irreducible inguinal hernia

Khoo PJ, Jacob S

J Surg Case Rep, 2017 Aug;2017(8):rjx161.
PMID: 28852466 DOI: 10.1093/jscr/rjx161

We present a case of omental fibroma, which posed a surgical diagnostic dilemma. Primary tumours of the omentum are uncommon, and omental fibromas account for 2% of these. The rarity of omental fibroma and paucity of available information hamper an accurate diagnosis. In this particular case, the diagnostic process was misleading. The history was classical of an irreducible inguinal hernia, but the physical examination and imaging studies were suggestive of a testicular tumour. However, intraoperatively, an omental tumour and a normal testicle were found in the scrotum. Histopathological examination proved the tumour to be a fibroma. The presentation of an omental fibroma in an inguinal hernia sac had never been reported in literature. Due to the rarity of such cases, a thorough history, detailed examination, and objective investigation are the pillars to attain the correct diagnosis.
Fulltext Polypharmacy in the management of patients with schizophrenia on risperidone in a tertiary-care hospital in Malaysia

Jacob S, Ibrahim MM, Mohammed F

Ment Health Fam Med, 2013 Jan;10(1):37-43.
PMID: 24381653

The present study was conducted primarily to determine the occurrence of polypharmacy in patients with schizophrenia on risperidone. The secondary aim was to ascertain the incidence of inappropriate prescribing with anticholinergics. A retrospective review of the medical records of all patients who were being followed up at the out-patient clinic of a tertiary-care hospital in Malaysia was conducted. Only patients who were being prescribed risperidone between 1 June 2008 and 31 December 2008 were included in the study. Demographic data such as patient's age, gender and race were obtained from the patient's medical records. In total, 113 patients met the selection criteria. Polypharmacy was found to occur in 34 patients (30.09%), with the majority (76.47%) being on two antipsychotics. In total, 27 patients (34.18%) on monotherapy with risperidone were prescribed an anticholinergic on scheduled dosing, while 19 patients (24.05%) were prescribed it on an as-needed basis. Of the patients on polypharmacy, 26 (76.47%) were on scheduled dosing of anticholinergics, while three (8.82%) were taking the medication on an as-needed basis. Polypharmacy should be avoided, and the use of anticholinergics should be closely reviewed. By adopting more efficient prescribing practices, costs can be reduced and financial resources can instead be channelled towards more beneficial areas for the patients.
Study site: Psychiatric clinic, tertiary hospital, Malaysia
Fulltext Post-caesarean septicaemia in Kandang Kerbau Hospital, Singapore, 1993-1995

Teo KP, Jacob SCM, Lim SH

Med J Malaysia, 1997 Dec;52(4):325-30.
PMID: 10968108

We reviewed all documented cases of septicaemia following caesarean deliveries in Kandang Kerbau Hospital between 1st January 1993 to 31st December 1995. There were 22 cases of septicaemia among 8201 caesarean births, and hence the incidence is 2.7:1000. There were 45,412 deliveries, and the overall caesarean section rate was 18.1%. Among the 22 documented cases of septicaemia which came under this study, the most common clinical conditions found were endomyometritis (7 cases), urinary tract infection (6 cases), and wound infection (3 cases). One of the three cases with wound infection also had pneumonia. There was one patient who had mild transient myocarditis. We could not determine with certainty any site of infection in five patients. The most common bloodstream bacterial isolates was Staphylococcus aureus (16), while the uncommon ones were Acinetobacter baumanii (2), Escherichia coli (1), Klebsiella sp. (1), Staphylococcus epidermidis (1), Streptococcus Group F (1), Peptostreptococcus species and Veillonella species (1). There was no mortality and prompt, vigorous treatment had led to uneventful recovery in all the cases.
Interventional cardiologists and risk of radiation-induced cataract: results of a French multicenter observational study

Jacob S, Boveda S, Bar O, Brézin A, Maccia C, Laurier D, et al.

Int J Cardiol, 2013 Sep 1;167(5):1843-7.
PMID: 22608271 DOI: 10.1016/j.ijcard.2012.04.124

Interventional cardiologists (ICs) are exposed to X-rays and may be at risk to develop cataract earlier than common senile cataract. Excess risk of posterior subcapsular cataract, known as radiation-induced, was previously observed in samples of ICs from Malaysia, and Latin America. The O'CLOC study (Occupational Cataracts and Lens Opacities in interventional Cardiology) was performed to quantify the risk at the scale of France.
Assessing the probability of having attained 16 years of age in juveniles using third molar development in a sample of South Indian population

Saranya K, Ponnada SR, Cheruvathoor JJ, Jacob S, Kandukuri G, Mudigonda M, et al.

J Forensic Odontostomatol, 2021 Apr 30;1(39):16-23.
PMID: 34057154

Juvenile crime or delinquency has been increasing at an alarming rate in recent times. In many countries, including India, the minimum age for criminal responsibility is 16 years. The present study aimed to estimate the probability of a south Indian adolescent either being or being older than the legally relevant age of 16 years using Demirjian's tooth formation stages. Orthopantomograms (OPG) of 640 south Indian adolescents (320 boys and 320 girls) aged between 12 and 20 years were retrospectively analyzed. In each OPG, Demirjian's formation stage of the mandibular left third molar was recorded and the data was subjected to statistical analysis. Descriptive and Pearsons correlation statistics were performed. The empirical probabilities were provided relative to the medico-legal question of predicting 16 years of age. The distribution of age throughout the 10th, 25th, 50th, 75th and 90th percentile follows a logical distribution pattern horizontally and vertically. Pearson's correlation statistics showed a strong positive correlation between the Demirjian's stages and age for both sexes. Therefore, it can be concluded that stage "F" can be used to predict the attainment of age equal to or older than 16 years with a probability of 93.9% for boys and 96.6% for girls.
Enhanced Solubility and Bioavailability of Dolutegravir by Solid Dispersion Method: In Vitro and In Vivo Evaluation-a Potential Approach for HIV Therapy

Chaudhary S, Nair AB, Shah J, Gorain B, Jacob S, Shah H, et al.

AAPS PharmSciTech, 2021 Apr 09;22(3):127.
PMID: 33835317 DOI: 10.1208/s12249-021-01995-y

Being a candidate of BCS class II, dolutegravir (DTG), a recently approved antiretroviral drug, possesses solubility issues. The current research was aimed to improve the solubility of the DTG and thereby enhance its efficacy using the solid dispersion technique. In due course, the miscibility study of the drug was performed with different polymers, where Poloxamer 407 (P407) was found suitable to move forward. The solid dispersion of DTG and P407 was formulated using solvent evaporation technique with a 1:1 proportion of drug and polymer, where the solid-state characterization was performed using differential scanning calorimetry, Fourier transform infrared spectroscopy and X-ray diffraction. No physicochemical interaction was found between the DTG and P407 in the fabricated solid dispersion; however, crystalline state of the drug was changed to amorphous as evident from the X-ray diffractogram. A rapid release of DTG was observed from the solid dispersion (>95%), which is highly significant (p<0.05) as compared to pure drug (11.40%), physical mixture (20.07%) and marketed preparation of DTG (35.30%). The drug release from the formulated solid dispersion followed Weibull model kinetics. Finally, the rapid drug release from the solid dispersion formulation revealed increased Cmax (14.56 μg/mL) when compared to the physical mixture (4.12 μg/mL) and pure drug (3.45 μg/mL). This was further reflected by improved bioavailability of DTG (AUC: 105.99±10.07 μg/h/mL) in the experimental Wistar rats when compared to the AUC of animals administered with physical mixture (54.45±6.58 μg/h/mL) and pure drug (49.27±6.16 μg/h/mL). Therefore, it could be concluded that the dissolution profile and simultaneously the bioavailability of DTG could be enhanced by means of the solid dispersion platform using the hydrophilic polymer, P407, which could be projected towards improved efficacy of the drug in HIV/AIDS.
Fulltext An Updated Overview of the Emerging Role of Patch and Film-Based Buccal Delivery Systems

Jacob S, Nair AB, Boddu SHS, Gorain B, Sreeharsha N, Shah J

Pharmaceutics, 2021 Aug 05;13(8).
PMID: 34452167 DOI: 10.3390/pharmaceutics13081206

Buccal mucosal membrane offers an attractive drug-delivery route to enhance both systemic and local therapy. This review discusses the benefits and drawbacks of buccal drug delivery, anatomical and physiological aspects of oral mucosa, and various in vitro techniques frequently used for examining buccal drug-delivery systems. The role of mucoadhesive polymers, penetration enhancers, and enzyme inhibitors to circumvent the formulation challenges particularly due to salivary renovation cycle, masticatory effect, and limited absorption area are summarized. Biocompatible mucoadhesive films and patches are favored dosage forms for buccal administration because of flexibility, comfort, lightness, acceptability, capacity to withstand mechanical stress, and customized size. Preparation methods, scale-up process and manufacturing of buccal films are briefed. Ongoing and completed clinical trials of buccal film formulations designed for systemic delivery are tabulated. Polymeric or lipid nanocarriers incorporated in buccal film to resolve potential formulation and drug-delivery issues are reviewed. Vaccine-enabled buccal films have the potential ability to produce both antibodies mediated and cell mediated immunity. Advent of novel 3D printing technologies with built-in flexibility would allow multiple drug combinations as well as compartmentalization to separate incompatible drugs. Exploring new functional excipients with potential capacity for permeation enhancement of particularly large-molecular-weight hydrophilic drugs and unstable proteins, oligonucleotides are the need of the hour for rapid advancement in the exciting field of buccal drug delivery.
Development and Optimization of Asenapine Sublingual Film Using QbD Approach

Dalal R, Shah J, Gorain B, Choudhury H, Jacob S, Mehta TA, et al.

AAPS PharmSciTech, 2021 Oct 04;22(7):244.
PMID: 34608546 DOI: 10.1208/s12249-021-02132-5

Asenapine, an atypical antipsychotic agent, has been approved for the acute and maintenance treatment of schizophrenia and manic episodes of bipolar disorder. However, the extensive hepatic metabolism limits its oral bioavailability. Therefore, the objective of the current investigation was to develop sublingual film containing asenapine to enhance the therapeutic efficacy. Sublingual films containing asenapine were fabricated using polyethylene oxide and hydroxypropyl methylcellulose by solvent casting method. Design of experiment was used as a statistical tool to optimize the proportion of the film-forming polymers in order to establish the critical quality attributes of the drug formulation. The process was studied in detail by assessing risk of each step as well as parameters and material attributes to reduce the risk to a minimum. A control strategy was defined to ensure manufacture of films according to the target product profile by evaluation of intermediate quality attributes at the end of each process step. Results of optimized formulations showed rapid disintegration, adequate folding endurance, good percentage elongation, tensile strength, and viscosity. Besides, the results from the in vitro dissolution/ex vivo permeation studies showed rapid dissolution (100% in 6 min) and higher asenapine permeation (~ 80% in 90 min) through the sublingual epithelium. In vivo study indicates greater asenapine absorption (31.18 ± 5.01% of administered dose) within 5 min and was comparable with marketed formulation. In summary, the designing plan to develop asenapine formulation was successfully achieved with desired characteristics of the delivery tool for sublingual administration.
Pharmacokinetics and tissue distribution of hydrazinocurcumin in rats

Satyavert, Gupta S, Choudhury H, Jacob S, Nair AB, Dhanawat M, et al.

Pharmacol Rep, 2021 Dec;73(6):1734-1743.
PMID: 34283375 DOI: 10.1007/s43440-021-00312-5

BACKGROUND: Curcumin, a natural polyphenol from Curcuma longa, is known to possess diversified pharmacological roles including anti-inflammatory, antioxidant, antiproliferative and antiangiogenic properties; however, its bioavailability is severely limited due to its poor solubility, poor absorption, rapid metabolism, and significant elimination. Hydrazinocurcumin (HZC), a novel analogue of curcumin has been reported to overcome the limitations of curcumin and also possesses multiple pharmacological activities. The present study aimed to evaluate the unexplored pharmacokinetic profile of this agent in experimental rats.
METHODS: Drug formulations were administered to the experimental animals via oral, intravenous and intraperitoneal routes. Blood samples were collected at different pre-determined time intervals to determine the pharmacokinetic parameters. To understand the biodistribution profile of HCZ, tissue samples were isolated from different groups of Sprague-Dawley rats at different time points. The pharmacokinetic parameters of HZC were evaluated after administration through oral (100 mg/kg), intraperitoneal (100 mg/kg) and intravenous (10 mg/kg) routes.
RESULTS: Significantly (p
Fulltext Association between alleles, haplotypes, and amino acid variations in HLA class II genes and type 1 diabetes in Kuwaiti children

Dashti M, Nizam R, Jacob S, Al-Kandari H, Al Ozairi E, Thanaraj TA, et al.

Front Immunol, 2023;14:1238269.
PMID: 37638053 DOI: 10.3389/fimmu.2023.1238269

Type 1 diabetes (T1D) is a complex autoimmune disorder that is highly prevalent globally. The interactions between genetic and environmental factors may trigger T1D in susceptible individuals. HLA genes play a significant role in T1D pathogenesis, and specific haplotypes are associated with an increased risk of developing the disease. Identifying risk haplotypes can greatly improve the genetic scoring for early diagnosis of T1D in difficult to rank subgroups. This study employed next-generation sequencing to evaluate the association between HLA class II alleles, haplotypes, and amino acids and T1D, by recruiting 95 children with T1D and 150 controls in the Kuwaiti population. Significant associations were identified for alleles at the HLA-DRB1, HLA-DQA1, and HLA-DQB1 loci, including DRB1*03:01:01, DQA1*05:01:01, and DQB1*02:01:01, which conferred high risk, and DRB1*11:04:01, DQA1*05:05:01, and DQB1*03:01:01, which were protective. The DRB1*03:01:01~DQA1*05:01:01~DQB1*02:01:01 haplotype was most strongly associated with the risk of developing T1D, while DRB1*11:04-DQA1*05:05-DQB1*03:01 was the only haplotype that rendered protection against T1D. We also identified 66 amino acid positions across the HLA-DRB1, HLA-DQA1, and HLA-DQB1 genes that were significantly associated with T1D, including novel associations. These results validate and extend our knowledge on the associations between HLA genes and T1D in Kuwaiti children. The identified risk alleles, haplotypes, and amino acid variations may influence disease development through effects on HLA structure and function and may allow early intervention via population-based screening efforts.
Fulltext Optimized Rivastigmine Nanoparticles Coated with Eudragit for Intranasal Application to Brain Delivery: Evaluation and Nasal Ciliotoxicity Studies

Bhanderi M, Shah J, Gorain B, Nair AB, Jacob S, Asdaq SMB, et al.

Materials (Basel), 2021 Oct 22;14(21).
PMID: 34771817 DOI: 10.3390/ma14216291

Rivastigmine, a reversible cholinesterase inhibitor, is frequently indicated in the management of demented conditions associated with Alzheimer disease. The major hurdle of delivering this drug through the oral route is its poor bioavailability, which prompted the development of novel delivery approaches for improved efficacy. Due to numerous beneficial properties associated with nanocarriers in the drug delivery system, rivastigmine nanoparticles were fabricated to be administer through the intranasal route. During the development of the nanoparticles, preliminary optimization of processing and formulation parameters was done by the design of an experimental approach. The drug-polymer ratio, stirrer speed, and crosslinking time were fixed as independent variables, to analyze the effect on the entrapment efficiency (% EE) and in vitro drug release of the drug. The formulation (D8) obtained from 23 full factorial designs was further coated using Eudragit EPO to extend the release pattern of the entrapped drug. Furthermore, the 1:1 ratio of core to polymer depicted spherical particle size of ~175 nm, % EE of 64.83%, 97.59% cumulative drug release, and higher flux (40.39 ± 3.52 µg.h/cm2). Finally, the intranasal ciliotoxicity study on sheep nasal mucosa revealed that the exposure of developed nanoparticles was similar to the negative control group, while destruction of normal architecture was noticed in the positive control test group. Overall, from the in vitro results it could be summarized that the optimization of nanoparticles' formulation of rivastigmine for intranasal application would be retained at the application site for a prolonged duration to release the entrapped drug without producing any local toxicity at the mucosal region.
Fulltext Identifying Mucormycosis Severity in Indian COVID-19 Patients: A Nano-Based Diagnosis and the Necessity for Critical Therapeutic Intervention

Asdaq SMB, Rajan A, Damodaran A, Kamath SR, Nair KS, Zachariah SM, et al.

Antibiotics (Basel), 2021 Oct 27;10(11).
PMID: 34827246 DOI: 10.3390/antibiotics10111308

The COVID-19 infection caused by the new SARS-CoV-2 virus has been linked to a broad spectrum of symptoms, from a mild cough to life-threatening pneumonia. As we learn more about this unusual COVID-19 epidemic, new issues are emerging and being reported daily. Mucormycosis, also known as zygomycosis or phycomycosis, causes severe fungal illness to individuals with a weakened immune system. It is a devastating fungal infection, and the most frequent kind is the rhino cerebral type. As a devastating second wave of COVID-19 sweeps India, doctors report several instances involving a strange illness-sometimes known as the "black fungus"-among returning and recovered COVID-19 patients. This paper analyzes the existing statistical data to address the severity of prevalence and further notes the nano-based diagnostic parameters, clinical presentations, its connection with other conditions like diabetes, hypertension, and GI disorders, and the importance of anti-fungal therapy in treating the same. Anti-fungal therapies, as well as surgical interventions, are currently used for the treatment of the disease. Proper and timely diagnosis is necessary, along with the reduction in the spread of COVID-19. From the review, it was found that timely pharmacologic interventions and early diagnosis by using a nano-based diagnostic kit can help control the disease. Additionally, this paper provides novel information about the nanotechnology approaches such as fungal detection biosensors, nucleic acids-based testing, point-of-care tests, and galactomannans detection, in the diagnosis of mucormycosis, and thereby reinforces the need for further research on the topic.

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