Journal of Pharmaceutical and Biopharmaceutical Research

Pharmaceutical Design, Formulation Optimization, and In Vitro Performance Profiling of Generic Lymecycline Capsules Using Validated Analytical Methods

Ali Raza — 2026-05-22

This study documents the stepwise development and evaluation of a generic Lymecycline 408 mg hard gelatin capsule manufactured locally in Pakistan. The formulation process began with the selection of suitable pharmacopeial excipients after conducting accelerated compatibility testing to ensure that no undesirable physical or chemical interactions occurred with the active ingredient. Based on these preliminary investigations, a stable capsule composition was finalized. The finished capsules were evaluated according to British Pharmacopoeia requirements. All tested quality attributes, including assay, dissolution behavior, content uniformity, and moisture content, were found to comply with the specified limits. These results confirmed the consistency and integrity of the developed dosage form. Quantitative analysis of Lymecycline was carried out using a high-performance liquid chromatography method that was validated prior to routine application. During validation, parameters such as specificity, precision under repeat and intermediate conditions, accuracy through recovery assessment, robustness against minor variations, and system suitability were carefully examined. The method demonstrated reliable and reproducible performance in line with internationally accepted regulatory standards. To assess comparative in-vitro performance, dissolution testing was performed using the USP paddle method in media representing gastric and intestinal pH conditions (pH 1.2, 4.5, and 6.8). In all cases, more than 85% of the drug was released within one hour. Statistical comparison with the reference product, Tetralysal® 300 mg, showed acceptable similarity and difference factor values, indicating comparable release profiles. Overall, the data support that the developed formulation performs equivalently to the reference product and may be considered suitable for local production and further regulatory processing.

An Electronic Analytical Balance: A Key Instrument in the Laboratory

Ritu Tiwari — 2025-10-20

Digital analytical balances are crucial in laboratory settings for accurately determining an object's mass. The precision of these balances highlights their importance in scientific endeavours. This study explores the significance of achieving equilibrium and other relevant concepts in analytics to advance the field. It examines a range of factors, with the balance as a focal point: identifying analytical challenges, where the balance plays a critical role in pinpointing potential areas of error or inconsistency; aligning well-established constitutive and operational concepts with these challenges; evaluating new theories; and developing clinical and laboratory tests based on current knowledge. This overview is a condensed compilation of data—sourced from pharmacopoeias and gathered via search engines such as Google Scholar, PubMed, and Scopus. The concept of balance is introduced not only as a physical principle but also as a pervasive notion that extends across various aspects of our work. The diverse array of motor skills is explored, accompanied by an essential scale for assessing them, shedding light on the depth and intricacy of the topic.

Analytical Quality by Design (AQbD) for Quality and Risk Assessment of Pharmaceuticals to Immunomarkers

Ritu Tiwari — 2025-10-17

Using advanced scientific and risk-based approaches for analytical methods offers significant benefits. Quality by Design (QbD) is a systematic framework that emphasizes understanding and controlling both product and process elements. Adhering to the principles outlined in the ICH guidelines can considerably improve the quality of drug substances, vaccines, immune markers, and medicinal products. This compliance not only enhances product quality but also drives continuous improvement and innovation throughout the entire product lifecycle. Developing and regulating analytical methods are vital for maintaining high standards of product quality. By employing sophisticated scientific techniques and risk-based strategies, stakeholders can use various analytical methods to ensure the consistent production of high-quality active pharmaceutical ingredients (APIs). Techniques such as size exclusion chromatography (SEC), high-performance liquid chromatography (HPLC), gel electrophoresis, Western blotting, SDS-PAGE, and enzyme-linked immunosorbent assays (ELISA) are essential for boosting industrial efficiency and reliability in the pharmaceutical sector. Each technique supports the rigorous testing and validation required for API production, ultimately facilitating the development of safe and effective medical products. Understanding the impact of variability on the performance and results of analytical methods is crucial. The QbD framework adopts a systematic approach that underscores the need to thoroughly understand and effectively manage various aspects of the product and its manufacturing processes—laying the groundwork for ongoing improvements and innovation throughout the product lifecycle. Additionally, strict development and regulation of analytical methods are key to achieving the highest standards of product quality. Fully grasping how variability influences the performance and outcomes of analytical methods is essential, as this understanding optimizes results and maintains consistent quality. Recognizing these dynamics enhances result reliability and supports the goal of delivering safer, more effective healthcare solutions.

Experimental Study on the Analgesic and Arresting Bleeding Effects of Curcuma Aromatica Salisb

Yumin Zhao — 2025-05-20

Objective: To explore and analyze the analgesic and arresting bleeding effects of Curcuma aromatica Salisb.
Methods: The aqueous extract and alcoholic extract with the analgesic and arresting bleeding effects come from the rhizome of C. aromatica. These effects can be analyzed by writhes of the abdominal cavity on mice, hot-plate test, bleeding time by cutting the mouse′s tail and recovery time of decalcifying plasma clotting.
Results: The aqueous extract and alcoholic extract of the rhizome of C. aromatica can effectively inhibit the writhing reaction of mice, and the effect intensity is similar. The high-dose group (10g/kg) of aqueous extract solution of C. aromatica could significantly shorten the bleeding time by cutting the mouse′s tail and the recovery time of decalcifying plasma clotting. There was a significant difference in pain by heat stimulation on mice before and after aqueous extract and alcoholic extract (P < 0.05).
Conclusion: The Curcuma aromatica has analgesic and arresting bleeding effects. The arresting bleeding effect is related to blood coagulation factors, and hemostatic activity is water-soluble.

A Detailed Review of pH and its Applications

Ritu Tiwari — 2025-04-04

The pH of a solution is an important measure of how acidic or alkaline it is. It shows the concentration of hydrogen ions in the solution through a negative logarithm. This measurement gives insight into how a substance behaves chemically. Scientists use a pH electrode to get accurate pH readings, which provides reliable measurements for different tests. pH is a key concept in chemistry and is relevant in many scientific fields, including biochemistry, biology, physics, medicine, agriculture, and environmental science. Keeping the right pH level is crucial in many industries, especially in chemical manufacturing, food production, and environmental protection, as it can directly affect the quality of lab results. Even small changes in pH can lead to major differences in the accuracy of analytical outcomes. This is particularly important when following strict guidelines in pharmacopoeias or conducting research using databases like Scopus and PubMed, where data accuracy is vital. This article explains the essential aspects needed to use pH measurement effectively in analysis. It provides a detailed look at other factors necessary for practical testing. Additionally, it highlights the various ways pH measurements are used, showing their importance across different scientific and industrial areas.

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.