Journal of Pharmaceutical and Biopharmaceutical Research

Phyllanthus emblica: A boon or bane - Unlocking the phytopharmaceutical profile

Ritu Tiwari — 2024-09-27

Herbal medicines have been utilised since ancient times to treat various diseases. Medicinal plants have played a significant role in global health, and despite the remarkable progress in modern medicine, plants continue to make a valuable contribution to health. Plants are abundant in tropical regions around the world. Recently, there has been a growing interest in drugs derived from higher plants, especially those used in phytotherapy. It is estimated that about 25% of all modern medicines are directly or indirectly derived from higher plants. In nature, herbs contain a variety of well-arranged medicinal properties. Their uniform medicinal compounds make herbal medicines more effective and of higher quality. Phyllanthus emblica has all the antidiabetic, antimicrobial, DPPH activity and chemical profiling for its potential under the Quality control assessment.

Phytochemical analysis and GC-MS based bioactive compounds determination of 60 days Nigerian Vigna Radiata aqueous root extract

Ebelechukwu C. Mmuta — 2024-09-19

In the present study, the sturdy root of Nigerian Vigna radiata (L.) commonly called mung bean was investigated for the phytochemical content. This was necessitated as a result of limited information observed on the phytochemical content of fully matured Nigerian Vigna radiata root. 60 days old Vigna radiata (L.) plant, a newly introduced crop in Nigeria, was harvested from the farm of National Biotechnology and Research Development Agency, Abagana Centre, Nigeria. The roots were neatly separated from the plant, rinsed well with distilled water, air dried and grounded into flour. The 60 days old Nigerian Vigna radiata root flour sample (NVrR) subjected to preliminary phytochemical assay revealed the presence of 12 bioactive compounds with a remarkable high percentage concentration of 26.780% recorded for flavonoids content. Tannins also recorded appreciable value of 8.927% while values < 5% were noted for the remaining compounds. Further confirmation of the actual bioactive compounds present in 60 days old NVrR through GC-MS studies, generated 30 observable peaks with 28 bioactive compounds identified through spectrum matching with MassHunter\Library\NIST14.L spectral database. The major component, eluted at RT 23.565 (peak area 33.38%) revealed a bioactive compound which has been reported as an active ingredient in the production of detergents and biodiesel. This discovery represents a groundbreaking innovation in the utilization of NVrR for the production of briquettes, offering a cost-effective alternative energy source. Isolation of the identified compounds may prove the NVrR an important raw material for industrial productions.

Phytochemical screening and GC-MS analysis of bioactive compounds present in methanolic extracts of 60 days old Nigerian Vigna Radiata leaves

Ebelechukwu C. Mmuta — 2024-07-29

Leaves of Vigna radiata (L.) are regarded as by-products due to the relatively low emphasis attributed to them when compared to the seeds and sprouts. They are usually left on the farm as waste products or for animals to graze on them, especially here in Nigeria; therefore, the need to investigate its various phytochemical content emerged, which will result in its optimum utilization. In the present study, 60 days old Vigna radiata (L.) leaves were harvested from V. radiata plants cultivated at the National Biotechnology and Research Development Centre Abagana, Anambra State, Nigeria. They were processed and milled into flour. Part of the milled flour was subjected to preliminary quantitative phytochemical screening, which revealed the presence of steroids as the major phytochemical content out of 12 bioactive compounds assessed with a value of 19.298%. The gas chromatography – mass spectrometry (GC-MS) used to determine the actual bioactive compounds present in the methanolic extracts of Nigerian V. radiata leaves (MENVrL) revealed the presence of 53 bioactive compounds with 58 peaks, covering a total peak area of 100% and these compounds were identified through spectrum matching with National Institute Standard and Technology (NIST) database. 2,4-Di-tert-butylphenol was identified as the major compound present in MENVrL with a peak area of 7.66%. Further isolation of these bioactive compounds may prove the leaves a rich source of pharmaceutical, biological, and cosmetologically important raw materials, for the formulation of new effective drugs and other related products.

The clinical and regulatory status of NDSRI: A global imperative

Ritu Tiwari — 2024-07-25

Detecting N-nitrosamine impurities in medicines has been a significant challenge for drug manufacturers and regulators, especially with the recent emergence of nitrosamine drug substance-related impurities (NDSRIs). The formation of NDSRIs is complex and primarily associated with reactions in the drug product. This paper explores the current technical knowledge on forming these impurities, including the risk factors, reaction conditions, and possible mitigation strategies. While significant scientific progress has been made in these areas, substantial gaps in mechanistic knowledge still make accurate predictions of NDSRI formation very difficult. The pharmaceutical industry's continued work on potential mitigation strategies and the generation of additional scientific data to address these knowledge gaps are crucial. Regulatory guidance and policy will continue to evolve in response to further changes in scientific understanding. In this article, we will delve into the detection methods, the mechanism of action, sample preparation techniques, and regulatory limits for nitrosamine impurities. We also discuss various reported nitrosamine impurities, their chemical structures, and their detection using methods like LC-MS/MS, GC-MS-HS, and HPLC. Additionally, we discuss different sample preparation techniques, such as solid-phase extraction, liquid-liquid extraction, and rapid-fire techniques. This review is intended to provide detailed information to analytical personnel working in various quality control laboratories and research organizations.

Blockchain technology for advanced therapy medicinal products: Applications in tracking, data sharing, and supply chain automation

Cristobal Aguilar-Gallardo — 2024-06-18

Advanced therapy medicinal products (ATMPs) like cell and gene therapies offer transformative treatment options for many diseases. However, coordinating the decentralized, patient-specific manufacturing of autologous ATMPs across multiple hospitals poses major supply chain challenges. This paper provides a comprehensive analysis of how blockchain technology can enhance decentralized ATMP manufacturing networks. First, background on ATMPs and complexities of decentralized production is reviewed. An overview of blockchain architecture, key attributes, and existing use cases then follows. The major opportunities for blockchain integration in ATMP manufacturing are discussed in depth, including tracking autologous products across locations, enabling data sharing between hospitals to power AI-based optimization, automating supply chain processes, and maintaining provenance records. Critical limitations around scalability, privacy, regulation, and adoption barriers are examined. Design considerations for developing blockchain ecosystems tailored to the unique ATMP environment are also explored. Blockchain shows immense promise for transforming visibility, coordination, automation, and data unification in decentralized ATMP manufacturing networks. Despite current challenges, blockchain is prepared to profoundly impact the advancement of personalized cell and gene therapies through enhanced supply chain instrumentation. This paper provides a comprehensive analysis of this emerging technological innovation and its applications to address critical needs in ATMP translation and manufacturing.

Anticonvulsant activities of the methanol crude extract and fractions of the leaf Solanum americanum (S.a.) in pentylenetetrazole and 4-amino pyridine induced seizure in white albino rats

Rita Nwabiani — 2024-05-31

This research investigated the anticonvulsant effect of the crude extract and fractions of Solanum americanum’s (S.a.) leaves on seizures induced by pentylenetetrazole (PTZ) and 4- amino pyridinein albino rats to authenticate the use of the leaves in the treatment of epilepsy in South -Eastern Nigeria. The leaves of S.a were extracted with methanol and fractionated using n-hexane, ethyl acetate and methanol. The parameters observed were onset of convulsions in minutes, duration of clonic phase in minutes, percentage protection from seizures and mortality. The anticonvulsant tests were carried out using 60 (sixty) white albino rats (weighing 80-136 g) of both sexes, varying concentrations of both methanol extracts and fractions (12.5, 25.0, 50.0, 100 and 200 mg/kg b.w.) were administered to the rats after which convulsion were induced in the rats using 9.0 mg/kg of PTZ and 1.5 mg/kg 4-amino pyridine on different groups (35 and 25) of rats respectively. The results of the various groups were compared with the control group and significance was analyzed by one-way ANOVA. The acute toxicity test was conducted at a dose of 3000 mg/kg. At a peak dose of 200 mg/kg methanol crude extract, hexane and methanol fraction in PTZ model protected the animals from seizure at 89.30%, 100%, 100% but gave 80%, 80% and 60% protection from mortality respectively. Hexane fraction (12.5, 25, 50, 100 and 200 mg/kg) protected the rats against mortality at 20%, 40%, 60%, 60% and 80% respectively, while no anticonvulsant activities were detected in ethyl acetate fraction. Differences among the means and standard deviation was statistically significant at P < 0.05.The acute toxicity test showed that the leaf of S.a. is non-toxic. The result obtained substantiated the use of the leaf of Solanum americanum ethnobotanically as anticonvulsant.

A big threat : Aflatoxin

Ritu Tiwari — 2024-05-22

The past decade has witnessed a tremendous surge of interest in herbal medicines throughout the world. Aflatoxins are naturally occurring mycotoxins that are mainly produced by Aspargillus flavus and Aspargillus parasiticus and primarily contaminate food crops such as corn, groundnuts, and tree nuts as well as herbal medicinal plants in tropical and subtropical regions of the world. It is a lethal substance that intensely or at slower ingestion influences the strength of humans and animals. Aflatoxin study is vital for a safety perspective as they are extremely lethal and cancer-causing; to overcome the health effect of aflatoxins and for better assessment and standardization of herbal plant drugs. The investigation includes worldwide regulations on aflatoxins with their acceptable ranges in commodities. With more controls for adequate dimensions of aflatoxins set up, present-day analytical techniques have turned out to be very modern, capable of accomplishing results with high accuracy and precision, appropriate for administrative research centers and post-reap sample testing in developed countries.

Determination of pesticide residues and heavy metals in Adhatoda Vasaka Linn.

Ritu Tiwari — 2024-05-15

Heavy metals and pesticide residue analysis plays an important role in the quality control of medicinal plants like Vasaka (Adhatoda vasica). Hence a study was conducted to determine heavy metals and pesticide residues in this medicinal herb, which is a highly useful commodity in the health system. The reliable, rapid and nontoxic sample preparation method like QuEChERS and analytical methods like GC-MS were proposed for the simultaneous determination of pesticide residues and Heavy metal detection was carried out by ICP-MS. In this study, the presence of organophosphorus and organochlorine pesticides like alachlor, heptachlor, heptachlor epoxide, aldrin, dieldrin, endrin, etc was checked but not detected. Heavy metals like Arsenic (As), Cadmium (Cd), Mercury (Hg) and Lead (Pb) are traced in samples about 2.3005 ppb, 0.799 ppb, 2.290 ppb and 10.204 ppb respectively in the present study.

TAAR1 as a new target for the treatment of bipolar disorder: Anti-manic and anti-depressant activity of the novel agonist PCC0105004

Linyao Yu — 2024-03-25

Background: Bipolar disorder (BD) is a deleterious psychiatric disorder, and the available pharmacotherapies have limited efficacy with significant side effects. Trace amine-associated receptor 1 (TAAR1) is an emerging drug target for neuropsychiatric disorders such as schizophrenia and substance user disorders. However, it is unknown whether TAAR1 is involved in the pathogenesis of BD. This study examined the effects and underlying mechanisms of a novel TAAR1 agonist, PCC0105004, in a rat model of ouabain (OUA)-induced BD.
Methods: Intracerebroventricular (ICV) administration of OUA-induced BD model was established. The in vitro cell-based cAMP assay was used to examine TAAR1 agonism of PCC0105004. The receptor specificity of PCC0105004 was determined by an off-target panel assay that included radioligand binding and enzymatic assays. The effects of PCC0105004 on manic-like and depressive-like behaviors were evaluated in the rat BD model. TAAR1-mediated signaling and oxidative stress parameters were biochemically determined in the prefrontal cortex and the hippocampus of rats.
Results: Western blotting revealed reduced TAAR1 expression level in the prefrontal cortex but unchanged in the hippocampus in model rats. PCC0105004, a TAAR1 agonist with the agonism EC₅₀ value of 0.06182 μM, attenuated the manic-like behaviors on the 7th day and the depressive-like behaviors on the 14th day at doses that did not affect locomotor activity in the BD rats. Mechanistically, PCC0105004 exerted its behavioral effects via the reduction of ROS damage through the phosphorylation activation of the TAAR1/Akt/GSK3β/BDNF signaling pathway.
Conclusion: These results demonstrated the potential antimanic-like and antidepressant-like efficacy of a novel TAAR1 agonist PCC0105004 in rats and revealed its underlying molecular basis, which supports the possibility of TAAR1 agonists as candidate pharmacotherapeutics for BD.

A novel role of NK3 receptor signaling in bipolar disorder

Wei Zhang — 2024-03-14

Objective: Bipolar disorder (BD) affects more than 1% of the global population with limited therapeutic options. The neurokinin B (NKB)-neurokinin B receptor (NK3R) is involved in a variety of emotional activities. This study explored the role of NK3 receptor signaling in bipolar disorder.
Materials and methods: In this study, a model of intracerebroventricular (ICV) administration of OUA-induced BD was used to investigate the possible role of NK3R signaling in BD. The involvement of NK3R in the expression of OUA-induced BD was assessed by genetically knocking down the NK3R-encoding TACR3 gene with shRNA approach in the hippocampus and systemic administration of a NK3R antagonist ESN364,. Biochemical techniques were used to examine the NK3R-associated signaling changes and the oxidative stress parameters in the hippocampus of BD rats.
Results: The NK3R expression level was elevated in the hippocampus BD rats. Both TACR3 knockdown in the hippocampus and ESN364 treatment reversed the manic-like and depression-like behaviors in BD rats Inhibition of the NK3R signaling reversed oxidative stress-induced damage via upregulating the BDNF signaling pathway in the hippocampus.
Conclusion: These results demonstrated that NK3R signaling plays a key role in the pathogenesis of BD and that pharmacological antagonist of NK3R such as ESN364 could represent a novel therapeutic strategy for the management of BD.