Journal of Biomedical and Pharmaceutical Research

Molecular Farming: Biotechnological Approaches for Producing High-Value Plant-derived Pharmaceuticals

Rashmi Jachak — 2024-09-05

Molecular farming is an advanced biotechnological breakthrough that utilises transgenic plants to behave as biofactories, manufacturing intricate and valuable medicinal proteins. This discipline combines modern genetic engineering techniques with conventional agricultural practices to facilitate the sustainable manufacturing of biopharmaceuticals, such as vaccines, monoclonal antibodies, and medicinal enzymes. Molecular farming enables the precise expression of therapeutic proteins by incorporating transgenes encoding these proteins into plant genomes. This process takes place in a regulated and biosafe environment, resulting in a cost-effective production system. This study explores advanced biotechnology methods that are now leading the field of molecular farming. The text emphasizes the utilization of cutting-edge gene-editing techniques, including Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR/Cas9) and Transcription Activator-Like Effector Nucleases (TALENs). These methods not only enable accurate genomic insertions but also improve the efficiency of gene expression at the transcriptional and translational levels in plant cells. The use of both conventional viral vectors and novel synthetic vector systems is crucial in guaranteeing the steady integration, expression, and inheritance of transgenes. In addition, the study examines numerous crucial case studies where molecular farming has been effectively employed. These activities encompass the creation of antigens for vaccines targeting infectious illnesses such as influenza and HPV, as well as the manufacturing of monoclonal antibodies for the treatment of autoimmune disorders and malignancies. The conversation encompasses the process of bringing these drugs generated from plants into the commercial market. It explores the case of Elelyso, a treatment that replaces enzymes and is manufactured from carrot cells, which has successfully entered the market.
Although molecular farming offers promise benefits, it faces several scientific and regulatory obstacles. Significant obstacles include the variation in protein expression levels across various plant hosts, challenges in extracting and purifying the proteins, and the requirement for substantial clinical studies to prove both safety and effectiveness. Furthermore, the regulations governing plant-derived medicines are intricate and strict, frequently necessitating tailored frameworks to accommodate the distinct characteristics of plant-based manufacturing systems. The report finishes by evaluating the future potential of molecular farming in relation to the changing requirements of the pharmaceutical business. The technology's intrinsic adaptability and capacity for expansion make it especially beneficial for quickly addressing health emergencies, such as pandemics, where conventional manufacturing methods may not be able to fulfill the immediate need for drugs. The ongoing progress in plant biotechnology, vector engineering, and regulatory science is expected to broaden the therapeutic uses of molecular farming, solidifying its role as a crucial component of cutting-edge drug production methods.

Keywords- Molecular farming, plant derived pharmaceuticals.

Formulation and Evaluation of Control Release Clopidogrel Bisulphate Microspheres

Ajay Singh — 2024-09-11

This study focuses on the formulation and evaluation of controlled-release microspheres for clopidogrel bisulfate, an antiplatelet agent widely used in the prevention of cardiovascular events. The objective was to develop a sustained-release delivery system that enhances the therapeutic efficacy of clopidogrel while improving patient compliance through reduced dosing frequency. Various biocompatible and biodegradable polymers, including poly (lactic-co-glycolic acid) (PLGA) and HPMC, were utilized to fabricate the microspheres using the solvent evaporation technique. The resulting microspheres were characterized for their physical properties, including particle size, morphology. In vitro drug release studies were conducted to evaluate the release kinetics of clopidogrel bisulfate from the microspheres over an extended period. The results indicated that the formulation achieved a sustained release profile, with a significant reduction in the initial burst release compared to conventional dosage forms. Kinetic modeling of the release data suggested a diffusion-controlled mechanism, indicating that the microspheres can maintain therapeutic drug levels for a prolonged duration.

Keywords: Anti-platelet agent, Microspheres, biocompatible, sustained-release delivery system.

A New Highly Effective Development and Validation of Trastuzumab and Hyaluronidase-Oysk in Bulk and Pharmaceutical Dosage form by Using RP-HPLC Method

Sruthi Babu — 2024-09-12

A simple, rapid, precise, sensitive, and reproducible Reverse phase High-performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Trastuzumab and Hyaluronidase-OYSK in the pharmaceutical dosage form. Chromatographic separation of Trastuzumab and Hyaluronidase-OYSK was achieved on Waters Alliance-e2695by using Agilent Eclipse XDB (250x 4.6mm, 5µ) column and the mobile phase containing Acetonitrile: Ammonium formate pH-3.0/OPA in the ratio of 30:70% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 228nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Trastuzumab and Hyaluronidase-OYSK were NLT 2000 and should not be more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Trastuzumab and Hyaluronidase-OYSK study of its stability.

Comparative Study of Itopride Hydrochloride in-Vitro Drug Release in Various Brands of Sustained Release Capsules By RP-HPLC

Anirudha Malik — 2024-09-26

Background: The World Health Organisation has advocated the use of generic medicines to make them accessible and affordable but studies have revealed that marketed products do not produce same therapeutic effects and hence are not interchangeable. Dissolution testing of generic solid dosage forms serves as a valuable tool for acquiring dissolution profiles and for assessing the similarity or dissimilarity between the formulations under examination.

Objectives:

To evaluate the in-vitro drug release profiles of different generic brands of Itopride Sustained release capsules that are commercially available in Indian market and compare them with the innovator product using model dependant and as well as model independent methods.
To determine whether same medicine manufactured by different brands are interchangeable.

Materials & Methods: In this study Eight generic brands of Itopride 150mg sustained release capsules available in the Indian market were evaluated using dissolution test with the aim to assess their bioequivalence with the innovator product (Ganaton OD). Dissolution studies were performed using USP type II apparatus at 100 rpm in 900 ml 0.1N HCl while maintaining a temperature of 37±0.5 ºC. The samples were estimated by a validated HPLC method.

Dissolution test results were statistically evaluated by employing both model dependant and model independent methods. In model dependant experimental data obtained for each dissolution profile were transformed by applying the equations of different kinetic models and the best-fit model was selected whereas in model independent approach fit factors, dissolution efficiency and mean dissolution times were calculated.

Results: The Weibull model best explained the release of drugs from all the brands. Upon statistical evaluation of dissolution test results its was found that while similarity factor f2 was within the limits for all generic brands, difference factor f1 of two brands was out of acceptable range thus questioning their bioequivalency with the innovator product. Also the dissolution efficiency of four out of the brands was out of acceptable limits.

Keywords: bioequivalence, difference factor (f1), similarity factor (f2), dissolution profile, comparison and evaluation..

Advances in Retinal Imaging Techniques: Oct, Fundus Autofluorescence, and Beyond

Pallavi Bhoyar — 2020-08-30

Background: Retinal imaging techniques have revolutionized the field of ophthalmology by enabling non-invasive visualization of the retina, facilitating early diagnosis and management of various retinal pathologies. This paper explores recent advances in retinal imaging, focusing on Optical Coherence Tomography (OCT), Fundus Autofluorescence (FAF), and emerging modalities. OCT, a cornerstone in retinal imaging, utilizes light interference to generate high-resolution cross-sectional images of the retina, optic nerve head, and choroid. Its applications span a wide range of retinal diseases, including age-related macular degeneration, diabetic retinopathy, and glaucoma. FAF imaging, on the other hand, captures the intrinsic fluorescence emitted by retinal fluorophores, providing valuable insights into retinal pigment epithelium (RPE) health and retinal dystrophies. This paper also discusses emerging techniques such as adaptive optics imaging, multimodal imaging, and the integration of artificial intelligence (AI) in retinal imaging analysis

Cosmeceuticals are the product of cosmetics that are biologically active ingredient that impersonates to medical or drug benefits. But the daily use of synthetic results in many side effects and need of organic lip balms is roaring in the society. In the

Anura David — 2024-10-15

Cosmeceuticals are the product of cosmetics that are biologically active ingredient that impersonates to medical or drug benefits. But the daily use of synthetic results in many side effects and need of organic lip balms is roaring in the society. In the present study we, aimed to formulate organic lip balm using natural ingredients. Lip balm has been formulated using Golden shower flower, red cabbage, honey, ghee, beeswax, vitamin E and coconut oil. Various parameters such as stability, melting point, spreadability, pH, were evaluated for the evaluation of lip balm. pH was found to be 6 and melting point was 60°C 65°C for cassia lip balm and red cabbage lip balm respectively. On preforming skin irritation test the formulation was found to be not irritant, and formulation was observed to be stable. Lip balm from above ingredients could be a better option for daily use to a small extend for minor lip issues.

Root Canal Treatment Failure: A Brief Review

Isha Tiwari — 2024-10-18

Root Canal Treatment (RCT) is a pivotal dental procedure that offers a chance to salvage teeth marred by infection or damage. This article delves into the complexities of RCT failures, examining the intricate reasons behind such occurrences. Despite its high success rate, RCT can face challenges, leading to complications and patient dissatisfaction. In this comprehensive exploration, we dissect the multifaceted causes of RCT failures, including incomplete removal of infected tissue, inadequate cleaning and shaping, poor restoration, undetected canals, fractured instruments, and external damage. Understanding these factors is indispensable for both dental professionals and patients. Incomplete removal of infected tissue, even in minute quantities, can provide a breeding ground for bacteria, resulting in reinfection. Inadequate cleaning and shaping of the root canals might leave debris behind, causing persistent infections. Restorations, a critical step post-RCT, demand precision; any ill-fitted or damaged restoration can lead to leakage, permitting bacterial ingress. The complexity of tooth anatomy occasionally conceals additional canals, which, if left untreated, can be a source of reinfection. Moreover, fractured instruments, a rare yet challenging scenario, can harbour bacteria if not managed meticulously. External damage, whether from trauma or fractures post-RCT, threatens the treated tooth’s integrity.

KEYWORD: RCT Failure, Endodontics, Root canal Therapy, Treatment Outcomes, Dental Microbiology.

A Comprehensive Guide to Root Canal Treatment

Srishti Songsoya Chatterjee — 2024-10-18

Traditional protocols involve cleaning the pulp chamber and root canals and removing the bacteria and the smear layer. Several globular and non-globular dentine types are revealed when the smear layer is removed. The dentinal walls should be cleaned before the lumen is chemically or mechanically enlarged. Apexogenesis and apexification are the sources of emerging pulp therapies that use totipotent, multipotent, or unipotent stem cells to help regenerate the tooth pulp.

Keywords: Root Canal Treatment, Contemporary techniques, Benefits of RCT

Comprehensive Overview of the Apicoectomy Procedure: Indications, Technique, and Postoperative Care.

Twinkle Agarwal — 2024-10-18

This review explores the theoretical and clinical aspects of the apicoectomy (root resection) process in periradicular surgery, which is crucial when standard root canal treatments fail. This procedure entails root apex amputation to resolve problems in the root area. Its goal is to eliminate enduring endodontic pathogens by employing surgical debridement, root-end resection, and canal obturation. The article consolidates extensive literature, emphasizing the procedure's significance in paediatric endodontics and updates in apical surgery. Providing a comprehensive overview, it highlights the procedure's advancements and its crucial role in managing endodontic concerns beyond traditional treatments.

KEYWORDS: Apicoectomy, Ramifications, Root Resection, Luebke-Oschenbein Flap, Guided Tissue Regeneration

Etiology, Diagnosis and Treatment of Dentin Hypersensitivity

Subhashree Sahoo — 2024-10-18

The hallmark of dentin hypersensitivity is sudden, intense pain brought on by exposed dentin, frequently resulting from gum recession and enamel loss. The hydrodynamic theory explains the symptoms, which connect fluid movement in dentinal tubules to nerve activity and external stimuli. A survey revealed a prevalence of over 60%, primarily affecting the lower incisors. Dental professionals could be misinformed about it. While management entails a customized strategy that includes professional treatments, self-care products, and oral health guidelines, diagnosis necessitates ruling out alternative reasons. Despite several potential interventions, there is no single or widely acknowledged remedy. Therefore, dentists should continue their education to correctly identify and treat dentin hypersensitivity.

KEYWORDS: Dentin hypersensitivity, hydrodynamic theory, exposed tooth, brushing technique, surgical technique