American Journal of Medical and Natural Sciences

Hyperemesis gravidarum; GDF15; GFRAL; PUQE-24; nausea and vomiting of pregnancy; ELISA; Iraq

Durar Kamil Jabbar — 2026-10-03

Background: Hyperemesis gravidarum (HG) is the severe end of nausea and vomiting in pregnancy. Growth differentiation factor 15 (GDF15), released by the placenta, acts on the brainstem emesis centre via the GFRAL receptor. Recent evidence from European cohorts places GDF15 at the centre of HG pathophysiology, yet no Iraqi data have been reported.Objective: To compare serum GDF15 between Iraqi women with HG and pregnant controls, and to explore its association with symptom severity.Methods: In this case–control study at Al-Diwaniyah Teaching Hospital, 80 women with HG (Windsor definition) and 80 pregnant controls at 7–14 weeks’ gestation were enrolled. Severity was graded with the PUQE-24 instrument. Serum GDF15 was measured by sandwich ELISA. Groups were compared with the Mann–Whitney U test; Spearman correlation between GDF15 and PUQE-24 within HG was computed with a bootstrap confidence interval; and multivariable models of ln(GDF15) used HC3-robust standard errors.Results: Median serum GDF15 was 14.15 ng/mL (Q1–Q3 10.64–16.60) in HG and 10.57 ng/mL (7.53–13.25) in controls (p < 0.001). The adjusted GDF15 ratio for HG versus controls was 1.373 (95% CI 1.218–1.547; p < 0.001). Within HG, Spearman's ρ between GDF15 and PUQE-24 was 0.235 (bootstrap CI −0.004 to 0.462; p = 0.036). Each PUQE-24 point corresponded to a GDF15 ratio of 1.058 (95% CI 1.003–1.116; p = 0.040). Geometric mean GDF15 rose from 9.99 ng/mL in controls through 12.38 in moderate HG to 14.99 ng/mL in severe HG (Kruskal–Wallis p < 0.001).Conclusion: Serum GDF15 was significantly higher in Iraqi women with HG than in controls, with a weak positive trend with symptom severity that did not reach significance by the bootstrap CI criterion. These findings support the GDF15–GFRAL model and further investigation of GDF15 as a severity marker in this population.

HERBAL BASED INTERVENTIONS IN CANCER THERAPY

Ashok Thippireddy — 2026-06-20

Cancer is complex and multifactorial disease that continues to be a major health concern worldwide. In spite of significant advances in conventional cancer curatives, there is a growing interest in exploring volition and complementary approaches to cancer treatment. Herbal natural products have been used for centuries in traditional drug to prevent and treat various conditions, including cancer. This review highlights the eventuality of herbal natural products as anti-cancer agents, focusing on their bioactive composites. This review explores the use of various parts of herbal medicinal plants and their active phytoconstituents in the prevention and treatment of various types of cancer. A comprehensive survey of literature was conducted using the multiple databases to identify anticancer medicinal plants and their uses. Identified herbs exhibit therapeutic effects via mechanisms such as inhibition of cancer-promoting enzymes and hormones, activation of DNA form processes, reduction of free radical revolutionary conformation, and Improvement of the immune system. Medicinal plants are majorly contributed to inhibiting the progression of cancer. Herbal anti-cancer medicines offer therapeutic advantages, particularly selective toxicity against cancer cells, reducing the adverse side effects associated with conventional chemotherapy. Multiple studies and clinical trials are investigating their efficacity, safety and mechanisms of action on different of cancers such as lung, prostate and, breast carcinoma.

NATURAL FOOD COLOURS Vs SYNTHETIC FOOD COLOURS: A HEALTHY PERSPECTIVE

Navya Udayagiri — 2026-06-20

ROLE OF RISK ASSESSMENT IN QBD IMPLANTATION OF PHARMACEUTICALS

Malathi Ullangi — 2026-06-20

Quality by Design is the ultramodern approach for quality of Medicinals. Recent pharmaceutical nonsupervisory documents have stressed the critical significance of applying quality by design (QbD) principles for in- depth process understanding to ensure that product quality is erected in by design. The purpose of this paper is to bandy the pharmaceutical Quality by Design and describe how it can be used to ensure pharmaceutical quality. Quality cannot be tested into products but quality should be erected in by design. Under this conception of QbD throughout designing and development of a product, it's essential to define desire product performance profile (Target product profile (TPP), Target product Quality profile (TPQP) and identify Critical quality attributed (CQA). passing the base of this we can design the product expression and the process to meet the product attributes. These leads to fete the impact of raw material Critical material attributes (CMA), Critical process parameter (CPP), on the CQA’s and identification and source of variability. QbD is necessary in nonsupervisory demand, and to apply new generalities similar as design space, ICH guidelines i.e. Q88 medicinal development, Q9 quality threat operation, and FDAs process logical technology (PAT Quality target product profile, important Quality characteristics, and important Quality rudiments through Desing. also, it provides a comparison of the product quality as determined by Quality by Design and as determined by final product testing.

POLYMER BASED GASTRO RETENTIVE DRUG DELIVERY SYSTEMS FOR SUSTAINED AND SITE SPECIFIC ACTION

Divyanjali Vetti — 2026-06-20

Gastro-retentive drug delivery systems (GRDDS) have emerged as an important new area of research in the field of oral pharmaceuticals, where the goal is to increase the therapeutic effect of a drug by extending the time it spends in the stomach, thereby improving its bioavailability . Current trends in GRDDSs involve the continual updating and expanding of the various types of GRDDS architecture, which include some higher-level floating GRDDS, mucoadhesive and bioadhesive formulations, expandable and swelling matrices, and superporous hydrogels. This is being done to provide for optimal retention and controlled release of these forms of drugs within the stomach. New polymer technologies, particularly biodegradable and other natural polymers, continue to be researched to improve the biocompatibility, while at the same time addressing the issues associated with safety and regulations surrounding their use. Also, the use of nanotechnology is becoming increasingly common within GRDDS systems, as both nanoparticle-based carriers and microspheres provide superior targeting accuracy, stability, and mucosal interaction. These developments are making GRDDS a more effective, patient-centric oral drug delivery system with significant clinical benefits.

Design And Fabrication of Microneedle For Controlled Drug Release

Annapurna Yarramsetty — 2026-10-10

Microneedle (MN) technology has emerged as a minimally invasive and effective substitute for conventional injectable and oral drug delivery systems. Although the approach has been widely explored, its clinical translation remains restricted because of limitations such as insufficient drug-loading capacity and challenges in achieving optimal therapeutic levels. Dissolvable and biodegradable microneedles are primarily applicable for low-dose treatments, including immunization and delivery of Highly potent medications.Microneedles provide a novel strategy for transdermal drug administration by overcoming the protective barrier of the epidermis. These micro-sized projections create temporary channels within the skin, thereby reducing barrier resistance and enhancing drug permeation. The technology has gained considerable interest in biomedical research due to its capability to deliver various therapeutic agents, including biological molecules, vaccines, pharmaceuticals, and other medicinal compounds, through the skin. Microneedle systems have demonstrated applications in vaccine delivery, systemic therapy, and cosmetic treatment. Continuous advancements in this technology highlight its potential to improve therapeutic effectiveness and patient adherence through safe and efficient transdermal drug delivery.

REGULATORY REQUIREMENTS FOR GENERIC DRUGS USED IN THE UNITED STATES OF AMERICA: A COMPREHENSIVE ANALYSIS OF THE FDA APPROVAL FRAMEWORK

Pavithra Bandi — 2026-08-31

Generic drugs have transformed the United States healthcare system by providing safe, effective, and affordable alternatives to innovator pharmaceutical products. The regulatory approval of generic medicines is governed by the United States Food and Drug Administration (FDA) through the Abbreviated New Drug Application (ANDA) pathway established under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch–Waxman Act. The introduction of this regulatory pathway significantly accelerated generic drug availability while preserving rigorous standards for pharmaceutical quality, safety, efficacy, and therapeutic equivalence. Since its implementation, generic medicines have substantially reduced healthcare expenditures and expanded patient access to essential medications. This review comprehensively examines the regulatory framework governing generic drug approval in the United States, including the historical evolution of generic drug legislation, the structure and requirements of the ANDA process, bioequivalence standards, Chemistry, Manufacturing, and Controls (CMC) requirements, current Good Manufacturing Practice (cGMP) compliance, patent certification procedures, Orange Book listings, labeling requirements, post-marketing surveillance, and recent regulatory developments under the Generic Drug User Fee Amendments (GDUFA). The review further discusses the scientific principles underlying bioequivalence, regulatory challenges associated with complex generic drugs, supply chain considerations, and future perspectives for generic drug regulation. The United States regulatory framework continues to evolve in response to advances in pharmaceutical science while maintaining a balance between encouraging pharmaceutical innovation and facilitating timely market access for cost-effective generic medicines. A comprehensive understanding of these regulatory requirements is essential for regulatory professionals, pharmaceutical scientists, academic researchers, healthcare providers, and policy makers involved in generic drug development and approval.