Drug Products Research Articles

Understanding the Challenges Associated with Approval of Anticancer Products to Facilitate the Regulatory Approvals: A Cross-sectional Study

Purpose: Oncological medications face a myriad of challenges, including technological, pre-clinical, clinical, and manufacturing, that lead to regulatory approval delays or failures. The present study aims to identify some challenges encountered by researchers or regulators during the development of novel cancer therapies. Methods: The present cross-sectional observational study used a mixed-method design methodology. The participants were selected via a non-random sampling method via self-selection and snowballing approach. A survey questionnaire was developed and circulated among the selected participants as a hard copy or email or a Google form. Open-ended and closed-ended questions were incorporated to identify the regulatory challenges faced during oncology drug development. The responses were collected from September 2021 to June 2022. These responses were then coded and themes were identified for the challenges. Results: A total of 87 responses were obtained for the questionnaire among the individuals contacted. Seven themes were identified from the collated responses that depicted the challenges for the regulatory approval of anticancer drug products. The majority of responders (38.2%) suggested reduced approval time whereas endpoint selection and study design were considered as a challenge by 12.0% of responders each. Furthermore, 6.0% of responders admit that timely interaction with the regulators is also a challenge that delays approval. Many challenges also exist during the product development phase; hence, 12.0% of responders reported safety issues, and 22.0% of responders reported technical issues during manufacturing as the cause of regulatory failure. Moreover, 12.0% of responders suggested the need for improvements in regulatory guidelines for oncology drug development. Conclusion: The survey indicates a lack of Indian guidelines for anticancer products, whereas limited guidance is available from other countries such as Europe or the United States. Thus, the survey points to the necessity for improvement in the regulatory guidelines and drug approval process to address the challenges unique to cancer drug development.

Phytochemical analysis of stem and leaves extracts of Tinospora cordifolia (Thunb.) Miers

Tinospora cordifolia (Thunb.) Miers is a large deciduous, creeping shrub belonging to the family Menispermaceae. The phytochemical analysis of the plants is very important commercially and has great interest in pharmaceutical companies for the production of the new drugs for curing of various diseases. The present study involves the qualitative phytochemical analysis of the selected medicinal plants. The aim of this study is carried out to analyze the phytochemical compounds in stem and leaves extracts of selected plant by using phytochemical screening tests. The leaf and stem extracts of the plant is expressed the presence of several phytochemicals viz., flavonoids, amino acids, diterpines, protein, saponins and carbohydrates. The result of phytochemical screening tests revealed that diterpines and carbohydrates are positive in all extracts. But flavonoids and saponins only present in methanol and ethanol extracts. The studies justify that T. cordifolia use in traditional medicines. The investigation further proposed that the phytochemicals present in stems and leaves of the plant, which can be used as natural antioxidants in medicinal drugs.

Representation of Native Hawaiian and Pacific Islander Individuals in Clinical Trials.

Having diverse participants in clinical trials ensures new drug products work well across different demographic groups, making health care safer and more effective for everyone. Information on the extent of Native Hawaiian and Pacific Islander participation in clinical trials is limited. To examine representation of Native Hawaiian and Pacific Islanders in clinical trials leading to the first US Food and Drug Administration (FDA) approvals for the 10 drug products with the top worldwide sales forecasts in 2024. Cross-sectional secondary analysis of existing data from clinical trials that took place from 2006 to 2021 in the US. All clinical trials that were included in the FDA first approval application for the 10 drug products were evaluated in this study. Data were analyzed from February to August 2024. Participation in a clinical drug trial. Comparison of the proportion of Native Hawaiian and Pacific Islander participation in clinical trials for the 10 drug products with top sales forecasts in 2024 to the Native Hawaiian and Pacific Islander population proportion. In this cross-sectional study of 139 062 individuals, Native Hawaiian and Pacific Islander participation in clinical trials for the 10 drug products with top sales forecasts was either unknown or low. For 6 of the 10 drug products (60%), the number of Native Hawaiian and Pacific Islander participants was not documented. All trials that reported Native Hawaiian and Pacific Islander participation had fewer Native Hawaiian and Pacific Islander participants than would be expected based on their US population proportion, with 2 of the differences being statistically significant. Of the trials that disaggregated Native Hawaiian and Pacific Islander participants from other racial groups, the number of Native Hawaiian and Pacific Islander participants was 8 for risankizumab-rzaa (0.38% of participants vs 0.49% of the population; percentage point difference, -0.11%; 95% CI, -0.37% to -0.15%), 7 for bictegravir/emtricitabine/tenofovir alafenamide (0.38% of participants vs 0.49% of the population; percentage point difference, -0.10%; 95% CI, -0.39% to 0.18%), 27 for 4vHPV/9vHPV (0.15% of participants vs 0.46% of the population; percentage point difference, -0.31%; 95% CI, -0.37% to -0.26%), and 90 for BNT162B2 COVID-19 vaccine (0.20% of participants vs 0.52% of the population; percentage point difference, -0.32; 95% CI, -0.36% to -0.27%). In this cross-sectional study, limited documentation and participation of Native Hawaiian and Pacific Islander individuals in clinical trials for drug products with top sales forecasts was found. This is especially concerning because Native Hawaiian and Pacific Islander individuals have a higher risk than other racial groups for type 2 diabetes, cancer, and several other conditions the products examined in this study treat. Given the importance of enrolling Native Hawaiian and Pacific Islander participants in clinical trials, sites should be established in key geographic regions, such as Hawai'i, and postmarket studies should be conducted within Native Hawaiian and Pacific Islander populations.

Perspectives on Drug Product Design Among Patients with Lung Cancer in the United Kingdom.

The use of oral anticancer medications has become more prevalent in cancer therapy. This is particularly the case in the management of advanced non-small cell lung cancer (NSCLC). However, when the treatment delivery interaction between the patient and the healthcare provider is removed, the risk of non-adherence increases. Insights into patient preferences can allow drug product formulation scientists to design more patient-centric medications that may promote an increase in adherence which, in turn, may lead to more beneficial health outcomes. We conducted an advisory board with patients with NSCLC in the United Kingdom to elicit and understand preferences for drug product attributes related to appearance, instructions, and modality. The advisory board was preceded by a quantitative preference survey that included three object-case best-worst scaling exercises and was followed by administering the same survey to a broader group of patients to confirm the results. Patients strongly prefer once-daily dosing over more frequent dosing, regardless of the number of pills because taking tablets or capsules multiple times each day can disrupt daily activities. In addition, patients place high importance on surface smoothness because a rough surface implies decreased swallowability. Finally, food restrictions involving directions regarding taking medication with or without food represent difficulties for patients with cancer. Results of the follow-up survey confirmed these results. Drug developers should attempt to limit the dosing of these medications to once-daily regimens, avoid surface roughness, and develop formulations that can be taken without regard to the timing of meals to the greatest extent possible.

IL-1 receptor antagonist: etiological and drug delivery systems overview.

This article is aims to provide an overview of studies reported in the literature to investigate the etiological role of IL-1/IL-1ra in various disease conditions and the different drug delivery systems developed to achieve IL-1ra as a possible therapeutic option. Studies reported in PubMed, Google scholar, and other open-source literature related to etiological involvement of IL-1ra in pathophysiological conditions and various drug delivery schemes developed for IL-1ra for its efficacy evaluation as a possible treatment for different disease conditions were surveyed. The pathophysiological conditions involving IL-1/IL-1 ra spanned CNS-related disorders, Diabetes, Cardiac disorders, Ocular disease conditions, Gastrointestinal conditions, Tumor growth & metastasis, and miscellaneous conditions. The drug delivery systems developed for IL-1ra included a commercial drug product, Gene therapy, Antibody fusions, Extended-release delivery systems, and Pegylated-IL-1ra systems.

Analytical microscopy techniques using coaxial and oblique illuminations to detect thin glass particulates generated from glass vials for parenteral drug products

Glass vials are the most widely used primary containers for the packaging of parenteral products due to their optical clarity, general inertness, and hermetic properties, but under certain circumstances, they can pose safety concerns. Most of these issues are related to the potential formation of glass particulates through delamination or precipitation, resulting from the chemical interaction between the drug product and the inner surface of the glass vial. Hence, it is imperative for pharmaceutical companies to conduct product-vial compatibility studies to determine the appropriate packaging/container closure system. To support this development activity, scientists need to develop analytical methods to detect subvisible glass particulates in parenteral products, along with the appropriate positive controls, to facilitate detection and identification. This paper outlines the utilization of coaxial/episcopic and oblique illumination microscopy, combined with spectroscopic techniques, to detect thin glass particulates generated from a modified procedure. It also showcases the importance of angle-dependent lighting in visualizing positive control samples containing thin glass particulates. The analytical microscopy techniques discussed in this paper can assist scientists in selecting suitable container closure systems for developing parenteral products.

The Impact of Generative Artificial Intelligence on Education: A Comparative Study

Generative Artificial Intelligence (GAI), also known as creative AI, is a technology capable of independently producing original and creative content, such as text, images, videos, music, or code. It uses machine learning algorithms to analyze and learn from a vast amount of data to generate similar or even innovative content. This type of AI is used in several fields, such as health for the production of new drugs, design to generate adaptive designs, video games to create immersive environments, and artificial intelligence to generate training data for new networks. Seizing the opportunities offered by AI innovations in education is crucial. We cannot afford to let time pass without doing anything and without benefiting from this technique. It is time to enhance traditional learning methods and adopt more innovative approaches that take advantage of the potential of AI, like content and exam generation, and also improve students' learning experience by exploiting their closeness to the technology. This paper aims to answer the question of when and how to use artificial intelligence responsibly, considering it as a technology and limiting its excessive use. Additionally, we present the impact of GAI through a comparative study of student performance in three exam types: a classical MCQ exam written by the teacher, an adaptive MCQ exam generated by GAI from a topic, and a third MCQ exam generated by GAI based on the content of the provided documents. This study is conducted on students undergoing a software testing training program. By evaluating their performance in the AI-generated adaptive MCQ exams and the traditional MCQ exam, we can gain insights into the potential of this technology to enhance educational practices and provide personalized learning experiences. This research will contribute to the ongoing discussion on responsible and effective utilization of GAI in education, paving the way for future advancements in the field.

An analysis of drug approvals in India over past 5 years

Background: Drug development is a tedious process and takes a long time for approval by regulatory authorities. With time, Indian authorities have revised rules and regulations for conducting clinical trials as well as for the marketing of drugs, impacting the number of drugs being approved. Method: The information about drug approvals from 2019–2023 was obtained from the CDSCO website. The single drug products were classified into 14 main anatomical therapeutic chemical (ATC) groups, while Fixed Dose Combinations (FDCs) were classified based on the system they act upon. Descriptive statistical analysis was done. The findings of our observational study were expressed as absolute numbers and percentages. Results: Total 362 drugs were approved. Out of these, 135 were single drug products, and the rest were FDCs. The highest & lowest number of drugs were approved in the year 2022 and 2019 respectively. Maximum single drug product approvals were seen in Category L-antineoplastic and immunomodulating agents, while maximum FDC approvals were for drugs acting on the endocrine system. Conclusion: There is a rising trend of approval for FDCs. The pattern of single drug products approval flattened over the years, coinciding with the implementation of new rules and regulations.

DNA-Based Chemical Unclonable Functions for Cryptographic Anticounterfeit Tagging of Pharmaceuticals.

Counterfeit products are a problem known across many industries. Chemical products such as pharmaceuticals belong to the most targeted markets, with harmful consequences for consumer health and safety. However, many of the currently used anticounterfeit measures are associated with the packaging, with the readout method and level of security varying between different solutions. Identifiers that can be directly and safely mixed into the product to securely authenticate a batch would be desirable. For this purpose, we propose the use of chemical unclonable functions based on pools of short random DNA oligos, which allow the integration of a cryptographic authentication system into chemical products. We demonstrate and characterize a simplified workflow for readout, showing that results are robust and clearly differentiate between the correct tag and a counterfeit. As a proof of concept, we demonstrate the labeling of an acetaminophen formulation with a chemical unclonable function. The acetaminophen was successfully authenticated from a subsample of the product at a DNA admixing concentration of below 50 ng/g. Stability tests revealed that the readout is stable at room temperature for several years, exceeding the shelf life of most drug products. Our work thus shows that chemical unclonable functions are a valid alternative to state-of-the-art anticounterfeit methods, enabling a secure authentication scheme that is physically linked to the product and safe for consumption. The method is widely applicable beyond pharmaceuticals, allowing for more secure product tracing across industries.

Cleaning Method Validation for Determination of Residues in Anti-Cancer Drug product for Injection by Using RP-HPLC Technique

Cleaning method validation is a part of good practices in pharmaceutical sector and need to seek the contamination present in production area. OBJECTIVE: An RP-HPLC method for the cleaning samples analysis for Anti-Cancer Drug product Melphalan Hydrochloride for Injection was develop and validated. The method was developed and validated for quantitation of Cleaning of residue left in the vessels of the production equipment’s. The analytical method used to determine the complete cleaning for Melphalan Hydrochloride for Injection by HPLC method. METHOD: The Cleaning validation was performed on Inertsil ODS,C18,(150mm×4.6mm,5μm) chromatographic column temperature at 40°C, and the detection wavelength was set at 260nm. Mobile Phase-A:10mL ammonium acetate, 88mL Purified water, 10mL acetic acid, 2mL Triethylamine, and Mobile Phase-B: 1mL Buffer, 10mL acetonitrile,190mL Purified water, and at a flow rate of 1.5 mL/min, and the injection volume was 10μL. RESULTS: The validation results of Melphalan Hydrochloride were linear over the concentration from 0.10 µg/mL to 0.75µg/mL (r = 1.00) and the recoveries from LOQ to 150% and precision ranged from 50% to 76% (RSD < 30%, n =9). CONCLUSION: This method has been validated successfully and all the results met the acceptance criteria. Hence method of Cleaning Validation is suitable for testing of residue sample of Melphalan Hydrochloride for Injection.

Recent Updates in Nanocrystal Technology: A Reference to Oral Drug Delivery System

Increasing the oral bioavailability of drugs that dissolve slowly may be possible with the use of nanocrystal technology. It is being employed for drug engineering and research after making rapid advancements in recent years. The manufacturing process for pharmaceuticals is significantly hampered by the low solubility and quick rate of dissolution of poorly soluble medications. When taken orally, medications that are poorly soluble often have low and inconsistent bioavailability, which could lead to therapeutic failure. Pure drug nanocrystals prepared via "bottom-up" or "topdown" procedu are able to significantly improve the way poorly soluble medications dissolve thanks to their enormous surface area, which in turn enhances oral absorption. Nanocrystal medications allow for the creation of various dosage formulations. The use of nanocrystal technology in pharmaceutical research, particularly for oral drug delivery systems, is the main focus of this review. First, a quick discussion on the characteristics of pharmaceutical nanocrystals and several nanocrystal technology preparation techniques is provided. The application of nanocrystal technology in pharmaceutical science is covered after a discussion of the creation of prolonged-release formulations. Next follows a brief overview of the scaling-up procedure, commercial nanocrystal drug products, and regulatory aspects of nanodrugs. This paper offers a thorough explanation of preparation techniques, their characterisation, and how they are used in oral drug delivery systems.

Evaluating surfactant effectiveness in preventing antibody adsorption directly on medical surfaces using a novel device

Biopharmaceuticals, specifically antibody-based therapeutics, have revolutionized disease treatment. Throughout their lifecycle, these therapeutic proteins are exposed to several stress conditions, for example at interfaces, posing a risk to the drug product stability, safety and quality. Therapeutic protein adsorption at interfaces may lead to loss of active product and protein aggregation, with potential immunogenicity risks. Non-ionic surfactants are commonly added in formulations to mitigate protein-surface interactions. However, their effectiveness varies with the monoclonal antibody (mAb), and model surface material. Extrapolating findings from model surfaces to real medical surfaces is challenging due to diverse properties.This study pioneers the evaluation of surfactant effectiveness in preventing mAb adsorption directly on medical surfaces at the medical bag/formulation interface, utilizing the ELIBAG device. The adsorption of different protein modalities, mAbs and antibody-drug conjugate (ADC), using three surfactants (PS80, PS20, and P188), was examined across various medical surfaces, IV bags and manufacturing bags, and model surfaces. Our findings reveal that surfactants prevent mAb adsorption depending on the mAb modality, surfactant type and concentration, and surface material. This research underscores the importance of considering real medical surfaces in direct contact with formulations, offering insights for enhancing drug product development and ensuring material-protein compatibility in real world use.

Environmental impacts of drug products: The effect of the selection of production sites in the supply chain

The environmental impact of drug products is largely determined by activities beyond the direct control of pharmaceutical companies, such as outsourced production of pharmaceutical building blocks. Therefore, this study evaluates the environmental impacts of a prostate cancer drug packaged in one blister (declared unit), thereby analysing the whole value chain to gain insight into 1) the main contributors to the impact of drug product production and 2) the effect of the geographical location of production of solvents and pharmaceuticals. The carbon and resource footprints of the entire life cycle of the drug product are determined, using the IPCC GWP 100 and the Cumulative Exergy Extraction from the Natural Environment methods, respectively. Unlike many other studies, the impacts of building blocks, called intermediate pharmaceutical ingredients (IPIs), are modelled based on primary data, literature and similar processes. The carbon footprint per declared unit equals 34 kg CO2-eq, of which IPIs and active pharmaceutical ingredient (API) production account for 96 %. The resource footprint is 647 MJex/declared unit, with IPI and API production accounting for 93 %. The main impact contributors of these processes are solvents and electricity consumption. Four alternative scenarios for IPI and API production are developed to evaluate the geographical influence of different production locations of solvents and pharmaceuticals between Europe and China. European production of solvents and pharmaceuticals appears to have the lowest carbon and resource footprint. In contrast, Chinese production of solvents and pharmaceuticals increases the carbon footprint by 49 %, while the resource footprint increases by only 4 %, although the natural resource consumption shifts from abiotic renewable resources and nuclear energy to fossil fuels. The high contribution of IPI production and the influence of geography of the supply chain highlight the need for accurate data from external suppliers to fairly estimate the environmental footprint of drug products.

Impact of surface tension, viscosity, pump settings, and nozzle size on filling process capability and accuracy in high-concentration biopharmaceuticals

Filling is the final critical unit operation in the manufacturing process of liquid biological drug products. This paper thoroughly investigates the influence and mechanisms of peristaltic pump settings, nozzle size, product surface tension and viscosity on the biopharmaceutical filling processes based on the established filling process model of surrogates. Our study highlights the significant role of pump settings in influencing filling process capability indexes, in addition to their primary function of regulating flow rate. Surface tension minimally impacts flow behavior but significantly regulates the final dropʼs behavior, with lower surface tension increasing dripping tendencies. Viscosity proves crucial; higher viscosity intensifies friction and head loss of filling flow in tube/nozzle, causing pressure and flow rate losses, more pronounced dripping, and worse filling accuracy. Furthermore, nozzle size moderates the impact of pump settings, surface tension, and viscosity on filling performance. Larger nozzles help mitigate these effects, contributing to enhanced stability in filling performance under challenging conditions. For high-concentration biopharmaceuticals with elevated viscosity during filling, utilizing larger nozzles and reducing pump speed could achieve enhanced Cpk values and improved filling accuracy. Understanding the complex interactions among these factors is vital for optimizing the biopharmaceutical industry, promoting cost-effective practices, and enhancing production efficiency.

A Novel Lipid Nanoparticle NBF-006 Encapsulating Glutathione S-Transferase P siRNA for the Treatment of KRAS-driven Non-small Cell Lung Cancer.

Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancers, and KRAS mutations occur in 25-30% of NSCLC. Our approach to developing a therapeutic with the potential to target KRAS mutant NSCLC was to identify a new target involved in modulating signaling proteins in the RAS pathway. Glutathione S-Transferase P (GSTP) known as a Phase II detoxification enzyme has more recently been identified as a modulator of MAP kinase-related cell-signaling pathways. Therefore, developing a GSTP siRNA may be an effective therapeutic approach to treat KRAS mutant NSCLC. The lead drug product candidate (NBF-006) is a proprietary siRNA-based lipid nanoparticle (LNP) comprising GSTP siRNA (NDT-05-1040). Here, studies using a panel of KRAS mutant NSCLC cell lines demonstrated that NDT-05-1040 is a very potent and selective GSTP siRNA inhibitor. Our Western blot analysis showed that NDT-05-1040 effectively decreased the phosphorylation of MAPK and PI3K pathway components while upregulating apoptotic signaling cascade. Our in vivo studies revealed statistically significant higher distribution of NBF-006 to the lungs and tumor as compared to liver. In the subcutaneous and orthotopic tumor models, NBF-006 led to a statistically significant and dose dependent anti-tumor growth inhibition. Further, quantitative image analysis of PCNA and PARP staining showed that NBF-006 decreased proliferation and induced apoptosis, respectively, in tumors. Additionally, in a surgically implanted orthotopic lung tumor model, the survival rate of the NBF-006 treatment group was significantly prolonged (P <0.005) as compared to the vehicle control group. Together, these preclinical studies supported advancement of NBF-006 into clinical studies.

Advancing pharmaceutical care in rural and underserved communities: Strategies for improving global healthcare access

Pharmaceutical care in rural and underserved communities faces significant challenges, including limited access to healthcare services, geographic isolation, and infrastructure deficiencies. This review explores innovative strategies to optimize patient care delivery and expand access to essential medications in these areas. It highlights the potential of telepharmacy and digital health solutions in bridging the gap between patients and pharmacists, ensuring timely consultations, and enhancing medication adherence. Additionally, community-based healthcare initiatives and pharmacist-led interventions are examined as practical solutions for improving care delivery at the grassroots level. The review further discusses necessary policy reforms and incentives that can support healthcare professionals in underserved regions, along with long-term strategies such as localized drug production and international collaboration to sustain improvements in global healthcare access. By integrating these approaches, healthcare disparities can be reduced, leading to improved outcomes for vulnerable populations worldwide. Keywords: Telepharmacy, Rural Healthcare. Medication Access, Pharmacist-led Interventions, Policy Reforms.

Green Chemistry in Pharmaceutical Synthesis: Sustainable Strategies for Drug Production

The world is shifting from traditional synthetic or chemical technologies towards greener methods due to increasing concerns about maintaining a clean and sustainable environment. The development of eco-friendly products through processes that support environmental sustainability is referred to as a "green approach." In the pharmaceutical industry, there is growing attention to green synthesis of chemicals and materials, both in research and applied science, because green chemistry eliminates harmful processes and materials while promoting innovation in drug and therapeutic agent development. Green chemistry encompasses chemical reactions that minimize environmental impact and reduce toxicity. This field is rapidly evolving within pharmaceutical synthesis, focusing on the creation of sustainable medicines. This review explores the principles and practical applications of this innovative strategy within the pharmaceutical sector. By using environmentally friendly chemical processes, green chemistry reduces hazardous materials and pollution. Its aim is to mitigate the environmental footprint of drug production without compromising the quality and effectiveness of medicines. The approach also emphasizes the use of renewable and sustainable resources, such as shifting from petrochemical-based to bio-based feedstocks, allowing pharmaceutical companies to reduce their greenhouse gas emissions

Pharmaceutical effluent degradation using hydrogen peroxide-supported zerovalent iron nanoparticles catalyst

Pharmaceutical effluents generated during drugs production and application are often times released into the water systems with little or no treatment, which could pose potential danger to the ecosystem. Advanced oxidation processes for organic pollutants treatment have gained wide consideration due to their effectiveness. In this work, hydrogen peroxide (H2O2) and hydrogen peroxide-supported nano zerovalent iron (H2O2@nZVIs) were deployed to study pharmaceutical effluents (PE) degradation via batch experiments, under various reaction time, (H2O2) and (H2O2@nZVIs) concentrations, pH, PE concentration, and temperature. The nZVIs was prepared from the green synthesis of Vernonia amygdalina leaf extract and characterized using different analytical tools such as Fourier Transform-Infrared Spectroscopy (FT-IR), Gas Chromatography Mass Spectroscopy (GC-MS), Scanning Electron Microscopy (SEM), and X-Ray Diffraction Spectroscopy (XRD). The FT-IR results showed the presence of -C = O, -NH, -OH, -C = C and, -C-O functional groups, SEM report showed that the morphology of the nZVIs is round in shape, while GC-MS revealed the presence of several phytochemicals. When the concentration of the effluent was increased from 10 to 30 ml, the percentage decolourization decreased from 74.74 to 51.96% and from 80.36 to 54.38% for H2O2 and H2O2@nZVI respectively, whereas when the contact time was increased from 10 to 60 min, the percentage decolourization rose from 70.39 to 83.49% for H2O2 and from 85.19 to 89.73% when H2O2@nZVI was used. When the effect of pH was assessed, it was observed that on increasing the pH from 2 to 10, the percentage decolourization rose from 74.5 to 80.25% for H2O2, however, with H2O2@nZVI, the percentage decolourization decreased from 81.50 to 68%. Maximum percentage decolourization of 57.10% and 94.56% for H2O2 and H2O2@nZVI was achieved at catalyst volume of 25 ml. For all the parameters tested, the H2O2@nZVIs performed much better indicating that the nZVIs enhanced the decolourization ability of the H2O2. The kinetic results showed that the decolorization of pharmaceutical effluent by both catalysts fitted very well with the second-order model, while thermodynamic properties of enthalpy change were found to be 10.025 and 27.005 kJ/mol/K for H2O2 and H2O2@nZVIs respectively suggesting that the oxidation process is endothermic in nature. This technique employed in using hydrogen peroxide-supported zero valent iron, proved to be highly efficient not only for pharmaceutical effluent degradation but also in the elimination of lead from the effluent.

Advancements in Ocular Therapy: A Review of Emerging Drug Delivery Approaches and Pharmaceutical Technologies

Eye disorders affect a substantial portion of the global population, yet the availability of efficacious ophthalmic drug products remains limited. This can be partly ascribed to a number of factors: (1) inadequate understanding of physiological barriers, treatment strategies, drug and polymer properties, and delivery systems; (2) challenges in effectively delivering drugs to the anterior and posterior segments of the eye due to anatomical and physiological constraints; and (3) manufacturing and regulatory hurdles in ocular drug product development. The present review discusses innovative ocular delivery and treatments, encompassing implants, liposomes, nanoparticles, nanomicelles, microparticles, iontophoresis, in situ gels, contact lenses, microneedles, hydrogels, bispecific antibodies, and gene delivery strategies. Furthermore, this review also introduces advanced manufacturing technologies such as 3D printing and hot-melt extrusion (HME), aimed at improving bioavailability, reducing therapeutic dosages and side effects, facilitating the design of personalized ophthalmic dosage forms, as well as enhancing patient compliance. This comprehensive review lastly offers insights into digital healthcare, market trends, and industry and regulatory perspectives pertaining to ocular product development.

A Summarized and Complete Review on Hypertension: Focusing the Audience of Diploma Pharmacy for Basic Understanding

Hypertension (HTN) commonly known as high blood pressure has become one of the most detrimental and life-threatening condition for public health. High blood pressure does not merely affect the heart muscles, but it is also a root cause of multiple dysfunctions of other systems. Untreated blood pressure can cause cardiac problems, ischemic conditions, stroke, renal difficulties, and optic nerve damage. One of the most problematic cause is “silent killer” which means high blood pressure demolishes and worsens the health of the affected person without showing any symptoms till the blood pressure reaches too high. HTN is a life-threatening problem that can be controlled and managed by medicinal or herbal products. This review contains the background, etiology, pathophysiology, and current treatments for high blood pressure. This review aims to deliver basic knowledge or understanding of HTN and management by using drug products with their mechanism of action.