Publications by authors named "Rahul G Ingle"

The discovery of branched molecules like dextrin by Schardinger in 1903 marked the inception of cyclodextrin (CD) utilization, catalyzing its journey from laboratory experimentation to widespread commercialization within the pharmaceutical industry. CD, a cyclic oligosaccharide containing glucopyranose units, acts as a versatile guest molecule, forming inclusion complexes (ICs) with various host molecules. Computational studies have become instrumental in elucidating the intricate interactions between β-CD and guest molecules, enabling the prediction of binding energy, forces, affinity, and complex stability.

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Microneedle technology revolutionizes ocular drug delivery by addressing challenges in treating ocular diseases. This review explores its potential impact, recent advancements, and clinical uses. This minimally invasive technique offers precise control of drug delivery to the eye, with various microneedle types showing the potential to penetrate barriers in the cornea and sclera, ensuring effective drug delivery.

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Article Synopsis
  • Adequate stabilization of protein-based biopharmaceuticals is crucial for their durability during manufacturing and storage, and the choice of excipients like histidine plays a key role in this process.
  • Histidine, an essential amino acid, is valued for its unique physicochemical properties that allow it to serve multiple functions such as a buffering agent, stabilizer, and antioxidant in formulations.
  • This review provides insight into the use of histidine in the biopharmaceutical industry, detailing its benefits, commercial applications, and interactions with proteins, ultimately highlighting both its potential and challenges in formulation strategies.
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mRNA-based vaccines are assured to significantly boost biopharmaceuticals since outbreak of coronavirus disease- 2019. Respiratory infections, such as influenza, SARS, MERS, COVID-19, and respiratory syncytial virus, often have high transmission rates due to their airborne spread. Respiratory infections can lead to severe illness and death.

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Purposes: We previously reported an unexpected phenomenon that shaking stress could cause more protein degradation in freeze-dried monoclonal antibody (mAb) formulations than liquid ones (J Pharm Sci, 2022, 2134). The main purposes of the present study were to investigate the effects of shaking stress on protein degradation and sub-visible particle (SbVP) formation in freeze-dried mAb formulations, and to analyze the factors influencing protein degradation during production and transportation.

Methods: The aggregation behavior of mAb-X formulations during production and transportation was simulated by shaking at a rate of 300 rpm at 25°C for 24 h.

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Several studies have revealed that SARS-CoV-2 damages brain function and produces significant neurological disability. The SARS-CoV-2 coronavirus, which causes COVID-19, may infect the heart, kidneys, and brain. Recent research suggests that monoamine oxidase B (MAO-B) may be involved in metabolomics variations in delirium-prone individuals and severe SARS-CoV-2 infection.

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Nucleic acid (NA)-based biopharmaceuticals have emerged as promising therapeutic modalities. NA therapeutics are a diverse class of RNA and DNA and include antisense oligonucleotides, siRNA, miRNA, mRNA, small activating RNA, and gene therapies. Meanwhile, NA therapeutics have posed significant stability and delivery challenges and are expensive.

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Sample preparation is considered as the bottleneck step in bioanalysis because each biological matrix has its own unique challenges and complexity. Competent sample preparation to extract the desired analytes and remove redundant components is a crucial step in each bioanalytical approach. The matrix effect is a key hurdle in bioanalytical sample preparation, which has gained extensive consideration.

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Liquid biopharmaceuticals including monoclonal antibodies (mAbs) have been widely acknowledged to undergo various stresses during shipping/handling and long-term storage. Several mechanical stresses including shaking during shipping has been widely known to cause protein aggregation and sub-visible particle (SbVP) formation in liquid biopharmaceutical formulations. However, shaking-induced degradation of freeze-dried (FD) biopharmaceuticals has seldomly been reported in the literature and therefore this type of stress is widely overlooked in industry due to their presumed high stability, especially when the formulations and freeze-drying processes are fully optimized.

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Prefilled dual chamber devices (DCDs) are combination products containing freeze-dried drug and diluent in two separate chambers of the device. DCDs provide high stability and convenience to patients and doctors, thus significantly improving product quality, patient compliance and market competitiveness. DCDs should also provide seal integrity, sterility and compatibility with biopharmaceuticals and avoid leachability and needle stick injuries.

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We have observed an interesting phenomenon in which grinding of freeze-dried monoclonal antibody X (mAb-X) formulation powder resulted to significant protein sub-visible particles (SbVPs) in the reconstituted liquid, which could only be observed by sensitive particle analytical methods such as MFI and DLS. Effects of grinding temperature and the free radical scavengers methionine and 3-carbamoyl-2,2,5,5-tetramethyl-1-pyrrolidin-yloxy free radical (CTPO) on the formation of SbVPs were also evaluated. Free radicals were observed by EPR and the amount of free radicals was correlated to the sample temperature prior to grinding.

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Human lymphatic filariasis although not fatal but poses serious socioeconomic burden due to associated disability. This is reflected by the huge magnitude of the estimated disability-adjusted life years of about 5.09 million.

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Introduction: Fueled by a growing global expectation of the health and medical fields, billions of dollars/euros/pounds are invested every year in the research of new biological and chemical entities. However, little interest is seen in the development of novel drug delivery systems. One such system, pre-filled syringe (PFS), was invented decades ago but is still a rare mode of delivery in many therapeutic segments.

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Anti-coagulants are one of the most important categories in healthcare therapeutics. For healthcare professionals dealing in cases of in-vivo blood clotting problems. Heparin and low molecular weight heparins (LMWHs) would be the first choice of drugs.

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