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Fulltext Life-threatening parapharyngeal and retropharyngeal abscess in an infant

Balasubramanian A, Shah JR, Gazali N, Rajan P

BMJ Case Rep, 2017 Oct 09;2017.
PMID: 28993356 DOI: 10.1136/bcr-2017-221269

Severe extensive deep neck abscess in an infant is uncommon. We share the case of a previously well 4-month old infant who was referred for a 4-day history of fever, lethargy and left lateral neck swelling. Contrast-enhanced CT scan revealed a large 5.3×8 cm collection involving the left parapharyngeal and retropharyngeal space, causing significant airway narrowing. 40 mL of frank pus was drained via intraoral incision and drainage with the aid of endoscope, and undesirable complications from an external approach were averted. The infant was extubated 48 hours postsurgery and was discharged home well after completion of 1 week of intravenous antibiotics. The child was discharged well from our follow-up at 1 month review. We discuss the pathophysiology of deep neck space abscesses, its incidence in the paediatric population and the various management options.
Dendrimer-mediated approaches for the treatment of brain tumor

Dwivedi N, Shah J, Mishra V, Mohd Amin MC, Iyer AK, Tekade RK, et al.

J Biomater Sci Polym Ed, 2016 May;27(7):557-80.
PMID: 26928261 DOI: 10.1080/09205063.2015.1133155

Worldwide, the cancer appeared as one of the most leading cause of morbidity and mortality. Among the various cancer types, brain tumors are most life threatening with low survival rate. Every year approximately 238,000 new cases of brain and other central nervous system tumors are diagnosed. The dendrimeric approaches have a huge potential for diagnosis and treatment of brain tumor with targeting abilities of molecular cargoes to the tumor sites and the efficiency of crossing the blood brain barrier and penetration to brain after systemic administration. The various generations of dendrimers have been designed as novel targeted drug delivery tools for new therapies including sustained drug release, gene therapy, and antiangiogenic activities. At present era, various types of dendrimers like PAMAM, PPI, and PLL dendrimers validated them as milestones for the treatment and diagnosis of brain tumor as well as other cancers. This review highlights the recent research, opportunities, advantages, and challenges involved in development of novel dendrimeric complex for the therapy of brain tumor.
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.
Fulltext Reduction of Motion Artifacts in the Recovery of Undersampled DCE MR Images Using Data Binning and L+S Decomposition

Bilal M, Anis H, Khan N, Qureshi I, Shah J, Kadir KA

Biomed Res Int, 2019;2019:6139785.
PMID: 31119178 DOI: 10.1155/2019/6139785

Background: Motion is a major source of blurring and ghosting in recovered MR images. It is more challenging in Dynamic Contrast Enhancement (DCE) MRI because motion effects and rapid intensity changes in contrast agent are difficult to distinguish from each other.
Material and Methods: In this study, we have introduced a new technique to reduce the motion artifacts, based on data binning and low rank plus sparse (L+S) reconstruction method for DCE MRI. For Data binning, radial k-space data is acquired continuously using the golden-angle radial sampling pattern and grouped into various motion states or bins. The respiratory signal for binning is extracted directly from radially acquired k-space data. A compressed sensing- (CS-) based L+S matrix decomposition model is then used to reconstruct motion sorted DCE MR images. Undersampled free breathing 3D liver and abdominal DCE MR data sets are used to validate the proposed technique.
Results: The performance of the technique is compared with conventional L+S decomposition qualitatively along with the image sharpness and structural similarity index. Recovered images are visually sharper and have better similarity with reference images.
Conclusion: L+S decomposition provides improved MR images with data binning as preprocessing step in free breathing scenario. Data binning resolves the respiratory motion by dividing different respiratory positions in multiple bins. It also differentiates the respiratory motion and contrast agent (CA) variations. MR images recovered for each bin are better as compared to the method without data binning.
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.
Fulltext Afghan women are essential to humanitarian NGO work

Essar MY, Raufi N, Head MG, Nemat A, Bahez A, Blanchet K, et al.

Lancet Glob Health, 2023 Apr;11(4):e497-e498.
PMID: 36863385 DOI: 10.1016/S2214-109X(23)00048-7
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 Awareness and preparedness of healthcare workers against the first wave of the COVID-19 pandemic: A cross-sectional survey across 57 countries

Huy NT, Chico RM, Huan VT, Shaikhkhalil HW, Uyen VNT, Qarawi ATA, et al.

PLoS One, 2021;16(12):e0258348.
PMID: 34936646 DOI: 10.1371/journal.pone.0258348

BACKGROUND: Since the COVID-19 pandemic began, there have been concerns related to the preparedness of healthcare workers (HCWs). This study aimed to describe the level of awareness and preparedness of hospital HCWs at the time of the first wave.
METHODS: This multinational, multicenter, cross-sectional survey was conducted among hospital HCWs from February to May 2020. We used a hierarchical logistic regression multivariate analysis to adjust the influence of variables based on awareness and preparedness. We then used association rule mining to identify relationships between HCW confidence in handling suspected COVID-19 patients and prior COVID-19 case-management training.
RESULTS: We surveyed 24,653 HCWs from 371 hospitals across 57 countries and received 17,302 responses from 70.2% HCWs overall. The median COVID-19 preparedness score was 11.0 (interquartile range [IQR] = 6.0-14.0) and the median awareness score was 29.6 (IQR = 26.6-32.6). HCWs at COVID-19 designated facilities with previous outbreak experience, or HCWs who were trained for dealing with the SARS-CoV-2 outbreak, had significantly higher levels of preparedness and awareness (p<0.001). Association rule mining suggests that nurses and doctors who had a 'great-extent-of-confidence' in handling suspected COVID-19 patients had participated in COVID-19 training courses. Male participants (mean difference = 0.34; 95% CI = 0.22, 0.46; p<0.001) and nurses (mean difference = 0.67; 95% CI = 0.53, 0.81; p<0.001) had higher preparedness scores compared to women participants and doctors.
INTERPRETATION: There was an unsurprising high level of awareness and preparedness among HCWs who participated in COVID-19 training courses. However, disparity existed along the lines of gender and type of HCW. It is unknown whether the difference in COVID-19 preparedness that we detected early in the pandemic may have translated into disproportionate SARS-CoV-2 burden of disease by gender or HCW type.