Development Of Pharmaceutical Products Research Articles

Development of carminative syrup to improve gastrointestinal prophylaxis

The carminative qualities of spices like asafoetida, clove, cumin, cardamom, fennel, honey, cinnamon and black pepper are highlighted in particular. Medicinal plants are widely recognized as a crucial and valuable resource for the development of pharmaceutical products. These herbal products possess carminative properties and offer additional health benefits in a wide range of therapeutic uses of carminative like as Anti-microbial, Diuretic, Irritable bowel syndrome, etc. To enhance their effects, formulations were made utilizing a geometrical approach and different weights of these powders were combined and evaluated. To confirm the quality and safety of the carminative syrup, organoleptic evaluation, physicochemical characteristics, rheological evaluation, and carminative potential were evaluated.

Sources of Cysteine-Based Pharmaceutical Drugs and Their Halal Aspects in Pharmaceutical Product Development

Indonesia is the country with the largest Muslim population in the world, so supplements and medicines consumed must be halal (permissible in Islamic law). Cysteine is an essential amino acid that is crucial to human biological functions. Cysteine can be used as a mucolytic agent to help thin mucus in respiratory diseases such as bronchitis or chronic obstructive pulmonary disease (COPD). It also serves as an antidote to acetaminophen for detoxification purposes or as an antidote to counteract paracetamol (acetaminophen) overdose, a commonly used drug to relieve pain and reduce fever. Additionally, it functions as a supplement. This research aims to comprehensively review the sources of cysteine, its production, and its use in pharmaceuticals, as well as the opinions of scholars regarding the halal aspects that need to be considered in developing pharmaceutical products containing cysteine. The methods employed include searching through references from research articles obtained from Google Scholar, ScienceDirect, NCBI, Elsevier, and the Qur'an, Hadiths, and other Islamic literature sources. The compound structures are depicted using the ChemSketch tool from ACD/Labs. Mucolytic and acetaminophen drugs, such as acetylcysteine, can be derived from both animal and plant sources through chemical and non-chemical separation processes. Cysteine is generally a precursor for the synthesis of acetylcysteine. Cysteine sourced from specific organs, such as pig hair, has differing opinions among various scholars regarding its permissibility. However, the prevailing view and fatwa tend to lean towards its prohibition, depending on the source, process, and urgency of its use.

Cracking the code: Spatial heterogeneity as the missing piece for modeling granular fluidized bed drying

Pharmaceutical twin-screw wet granulation is a multifaceted and intricate process pivotal to drug product development. Accurate modeling of this process is indispensable for optimizing manufacturing parameters and ensuring product quality. The fluid bed dryer, an integral component of this granulation process, significantly influences the granular critical quality attributes. This study builds upon prior research by integrating experimental findings on granule segregation during fluid bed drying into an existing compartmental model, enhancing its predictive capabilities. An additional model layer on granule segregation behavior is composed and integrated into the existing model structure in this study. The added model compartment describes probability distributions on the vertical position of granules within each granule size class considered. To beware of overfitting, predictions of both the moisture content after drying and the granule bed temperature throughout drying are discussed in this study relative to experimental data from earlier published studies. These independent analyses demonstrated a marked improvement in prediction accuracy compared to earlier published model structures. The refined model accurately predicts the residual moisture content after drying for an untrained formulation. Moreover, it simultaneously makes accurate predictions of the granular bed temperature, which emboldens its structural correctness. This advancement makes it a powerful tool for predicting the behavior of the pharmaceutical fluid bed drying, which holds significant promise to facilitate pharmaceutical product development.

Knowledge-based: facilitating access to medicines in Latin America

The World Health Organization (WHO), with the scientific support of the International Pharmaceutical Federation (FIP), guides the development of multisource pharmaceutical products for market authorization using in vivo bioequivalence studies or, where applicable, in vitro biowaiver strategies based on the Biopharmaceutical Classification System (BCS). A review of the regulatory framework guiding generic medicines approval in Latin American countries revealed that less than 50% of regional health authorities offer a generic medicines development pathway utilizing a BCS-based biowaiver strategy. Aligned with the ONE FIP Strategy to facilitate access to medicines, a regional case study was carried out to implement and harmonize BCS-based biowaiver knowledge in Latin American countries. A steering committee involving regional representatives from health authorities, the pharmaceutical industry, and universities were established to coordinate to develop activities. A series of digital engagement events were held in Spanish and English with representatives from Latin America to share knowledge on BCS-based regulatory strategy, promote collaborations, and explore the alignment of biowaiver approval and regulatory pathways among Latin American countries. Feedback from diverse Latin American stakeholders demonstrated inconsistent implementation of bioequivalence testing within the region. However, there is support for a synergistic approach among countries to reduce duplication and increase efficiency in market authorization for generic medicines. This includes alignment with the WHO Prequalification of Medicines program as well as the development of a computational database for the classification of active pharmaceutical ingredients to demonstrate therapeutic interchangeability of immediate-release oral dosage forms according to the BCS. FIP-facilitated digital learning opportunities raised awareness of the BCS-based biowaiver regulatory strategy among Latin American stakeholders. It resulted in a plan to continually strengthen collaborative efforts in the region to harmonize regulations relevant to drug development generics medicines to introduce cost-effective medicines products that benefit public health.

Ethyl acetate fraction of Sargassum pallidum extract attenuates particulate matterinduced oxidative stress and inflammation in keratinocytes and zebrafish

Objective: To evaluate the effect of the ethyl acetate fraction derived from Sargassum pallidum extract against particulate matter (PM)-induced oxidative stress and inflammation in HaCaT cells and zebrafish. Methods: HaCaT cells and zebrafish were used to evaluate the protective effects of the ethyl acetate fraction of Sargassum pallidum extract against PM-induced oxidative stress and inflammation. The production of nitric oxide (NO), intracellular ROS, prostaglandin E2 (PGE2), and pro-inflammatory cytokines, and the expression levels of COX-2, iNOS, and NF-κB were evaluated in PM-induced HaCaT cells. Furthermore, the levels of ROS, NO, and lipid peroxidation were assessed in the PM-exposed zebrafish model. Results: The ethyl acetate fraction of Sargassum pallidum extract significantly decreased the production of NO, intracellular ROS, and PGE2 in PM-induced HaCaT cells. In addition, the fraction markedly suppressed the levels of pro-inflammatory cytokines and inhibited the expression levels of COX-2, iNOS, and NF-κB. Furthermore, it displayed remarkable protective effects against PM-induced inflammatory response and oxidative stress, represented by the reduction of NO, ROS, and lipid peroxidation in zebrafish. Conclusions: The ethyl acetate fraction of Sargassum pallidum extract exhibits a protective effect against PM-induced oxidative stress and inflammation both in vitro and in vivo and has the potential as a candidate for the development of pharmaceutical and cosmeceutical products.

Gc-ms analysis of leaf and rhizome essential oil of zingiber purpureum roxb. From bangladesh

Essential oils (EOs) are among the most important plant secondary metabolites. Zingiber purpureum Roxb. is a tropical ginger from Bangladesh, but its chemical constituents of leaves and rhizomes, both EOs, may have pharmacological effects. The aim of this study was carried out to analyze the qualitative composition of both Essential oils (EOs) of both leaf and rhizomes of Z. purpureum. The EOs from the leaves and rhizomes were extracted by hydrodistillation. Chemical constituents of the EOs were separated and identified by gas chromatography/mass spectrometry (GC/MS), and the relative percentage of each constituent was determined by area normalization. In total, 81 compounds were identified from leaf EOs, whereas 44 were from rhizome EOs. The common compounds identified from both rhizome and leaf EOs were triquinacene, 1,4, bis (methoxy), b-phellandrene and b-sesquiphellandrene, respectively. Besides, the major constituents of leaf EOs were sabinine (14.99%), b-pinene (14.32%), caryophyllene oxide (13.85%), and caryophyllene (9.47%), whereas the rhizome EOs confirmed (Z)-ocimene (21.97%), 4-terpineol (18.45%), γ-terpinene (3.86%) and cis-sabinenehydrate (3%). These EOs could be a promising source for the development of nutraceuticals, functional foods, and pharmaceutical products due to their potent activities and exploitation. Bangladesh J. Bot. 53(1): 153-158, 2024 (March)

A prediction model based on artificial intelligence techniques for disintegration time and hardness of fast disintegrating tablets in pre-formulation tests

BackgroundThe pharmaceutical industry is continually striving to innovate drug development and formulation processes. Orally disintegrating tablets (ODTs) have gained popularity due to their quick release and patient-friendly characteristics. The choice of excipients in tablet formulations plays a critical role in ensuring product quality, highlighting its importance in tablet creation. The traditional trial-and-error approach to this process is both expensive and time-intensive. To tackle these obstacles, we introduce a fresh approach leveraging machine learning and deep learning methods to automate and enhance pre-formulation drug design.MethodsWe collected a comprehensive dataset of 1983 formulations, including excipient names, quantities, active ingredient details, and various physicochemical attributes. Our study focused on predicting two critical control test parameters: tablet disintegration time and hardness. We compared a range of models like deep learning, artificial neural networks, support vector machines, decision trees, multiple linear regression, and random forests.ResultsA 12-layer deep neural network, as a form of deep learning, surpassed alternative techniques by achieving 73% accuracy for disintegration time and 99% for tablet hardness. This success underscores its efficacy in predicting complex pharmaceutical factors. Such an approach streamlines the drug formulation process, reducing iterations and material consumption.ConclusionsOur findings highlight the deep learning potential in pharmaceutical formulations, particularly for tablet hardness prediction. Future work should focus on enlarging the dataset to improve model effectiveness and extend its application in pharmaceutical product development and assessment.

Pediatric Formulations Developed by Extrusion-Based 3D Printing: From Past Discoveries to Future Prospects.

Three-dimensional printing (3DP) technology in pharmaceutical areas is leading to a significant change in controlled drug delivery and pharmaceutical product development. Pharmaceutical industries and academics are becoming increasingly interested in this innovative technology due to its inherent inexpensiveness and rapid prototyping. The 3DP process could be established in the pharmaceutical industry to replace conventional large-scale manufacturing processes, particularly useful for personalizing pediatric drugs. For instance, shape, size, dosage, drug release and multi-drug combinations can be tailored according to the patient's needs. Pediatric drug development has a significant global impact due to the growing needs for accessible age-appropriate pediatric medicines and for acceptable drug products to ensure adherence to the prescribed treatment. Three-dimensional printing offers several significant advantages for clinical pharmaceutical drug development, such as the ability to personalize medicines, speed up drug manufacturing timelines and provide on-demand drugs in hospitals and pharmacies. The aim of this article is to highlight the benefits of extrusion-based 3D printing technology. The future potential of 3DP in pharmaceuticals has been widely shown in the last few years. This article summarizes the discoveries about pediatric pharmaceutical formulations which have been developed with extrusion-based technologies.

Lactoferrins in Their Interactions with Molecular Targets: A Structure-Based Overview.

Lactoferrins and lactoferrin-derived peptides display numerous functions linked to innate immunity in mammalians, spanning from antimicrobial to anti-inflammatory and immunomodulatory actions, and even demonstrate antitumor properties. To date, the proposed mechanisms for their biological actions are varied, although the molecular basis that governs lactoferrin interactions with molecular targets has been clarified only in a limited number of specific cases. However, key in silico methods have recently moved the topic to the fore, thus greatly expanding the possibilities of large-scale investigations on macromolecular interactions involving lactoferrins and their molecular targets. This review aims to summarize the current knowledge on the structural determinants that drive lactoferrin recognition of molecular targets, with primary focus on the mechanisms of activity against bacteria and viruses. The understanding of the structural details of lactoferrins' interaction with their molecular partners is in fact a crucial goal for the development of novel pharmaceutical products.

The Regulatory Affairs Automation tools used in the Pharmaceutical Industry: An overview

Automation is becoming increasingly prevalent in various industries, including healthcare and pharmaceuticals. The pharmaceutical business is influenced by a variety of worldwide trends, with one of the most significant being the use of automation technologies, which will have a transformative effect on the research and development of new pharmaceutical products as well as the speed and efficiency with which products reach patients in need. Regulatory automation is enabled by a variety of technology tools, such as Electronic Document Management Systems, Regulatory Information Management (RIM) Systems, Artificial Intelligence (AI) Analytics Tools, Natural Language Processing (NLP) Tools, and Submission Publishing Tools. Automation tools can be used to automate regulatory activities such as administrative work, dossier completion, data extraction, auditing, regulatory implementation as well as quality management. Automation tools establish process links and minimize complexity, resulting in a more efficient management system. Human-AI interaction creates new prospects in regulatory concerns. This article investigates the potential use of automation techniques in pharmaceutical regulatory concerns.

Effects of heat treatment on the chemical composition, antioxidant activity, and toxicity of agarwood oil

The fragrant compound in agarwood has been a valuable ingredient in perfumery. The agarwood oil that is extracted using hydro-distillation technique undergoes a certain heat treatment to blend well with other compounds. As it is highly prized and proprietary, information on the effects of heat treatment on the agarwood oil is limited, hindering its potential as a bioresource in other pharmaceutical and cosmeceutical applications. In this study, we reveal the effects of heat treatment on agarwood oil, with a special focus on terpene compounds – an important chemical component found in agarwood. We found that agarwood oil was thermally stable at the temperatures of 80 °C, 120 °C, and 180 °C and time points 5 min, 10 min, and 20 min, respectively, without causing major loss in its terpene compounds, including monoterpenes, diterpenes sesquiterpenes, and sesquiterpenoids. Further analysis using the DPPH (2,2-diphenyl-1-picrylhydrazyl) antioxidant assay showed an overall increase in free radical scavenging activity for these heated agarwood oil. Additionally, the heat-treated agarwood oil did not return with any toxic effects on mononuclear blood cells. The findings of this study would be beneficial to the downstream applications of agarwood oil in perfumery and pharmaceutical product development.

Feasibility of Powder‐Based High‐Throughput Synthesis for Ceramics Development: Case Study on the Influence of Calcination Temperature in BiFeO3‐BaTiO3

Recent advances in machine learning capabilities have increased interest in materials research to improve the efficiency of materials discovery and optimization as well as to better understand the underlying phenomena responsible for the observed physical properties. While combinatorial chemistry and compositional engineering is well established in the development of pharmaceutical and chemical products, its use in the field of bulk functional polycrystalline ceramics is far from mature. In this work, a critical review of a high‐throughput powder‐based dispensing system is provided and the challenges involved with the transition from a conventional, human resources intensive workflow to a fully automated process are highlighted. Based on the lead‐free piezoelectric BiFeO3–BaTiO3 binary system, the applicability and robustness of high‐throughput engineering is investigated to increase data point density in phase diagrams, including the composition variations of the resulting materials. This work presents 16 different BiFeO3–BaTiO3 compositions at four different calcination temperatures, both demonstrating the potential of the system. This is coupled to automated crystal structure analysis, which will be used to investigate the role of calcination temperature on the resulting compositions at room temperature.

Development of a Cr2AlC MAX phase/g-C3N4 composite-based electrochemical sensor for accurate cabotegravir determination in pharmaceutical and biological samples.

Ahighly sensitive electrochemical sensor is reportedthat employs a modified electrode for the precise measurement of cabotegravir, a potent anti-HIV drug. Cyclic voltammetry (CV), differential pulse voltammetry (DPV), and electrochemical impedance spectroscopy (EIS) were utilized for this purpose. Electrode modification involved the immobilization of Cr2AlC MAX phase/g-C3N4 onto a glassy carbon electrode (GCE) to enhance its electrocatalytic activity and selectivity for cabotegravir detection. Under the optimal experimental conditions, the working potential (vs. Ag/AgCl) was to 0.93V. The developed sensor exhibited a good linear relationship in the range 0.05µM to 9.34µM with a low limit of detection of 4.33nM, signifying its exceptional sensitivity. Additionally, it demonstrated successful cabotegravir detection in pharmaceutical formulations and biological samples, achieving an RSD below 3.0%. The recoveries fell within the range 97.7 to 102%, confirming the sensor's potential for real-sample applications. This innovative electrochemical sensor represents a significant advancement, providing a simple, reliable, and sensitive tool for the accurate measurement of cabotegravir. Its potential applications include optimizing drug dosages, monitoring treatment responses, and supporting the development of cabotegravir-based pharmaceutical products, thereby contributing to advancements in HIV therapy and prevention strategies.

Biodiversity and Healing: Exploring the medicinal potential of wild edible plants abundant in antioxidants

Wild edible plants (WEPs) are rich in antioxidants with a history of traditional medicinal use. This study aimed to find the most efficient polyphenol extraction solvent from WEPs, including Lasia spinosa, Eriosema chinense, Nasturtium indicum, Begonia hatacoa, and Embelia floribunda, for pharmaceutical and drug industry applications. Polyphenols, crucial antioxidants, were meticulously analyzed via RP-HPLC. Total phenolic, flavonoid, and flavonol levels were measured with four solvents. 80% aqueous (aq.) ethanol proved the most effective, surpassing solvents of varying polarities. The plants exhibited high total phenolics and flavonols, notably gallic acid (30.78±1.67 µg/mg dry extract) and syringic acid (32.03±1.89 µg/mg dry extract) in 80% Aq. ethanol extract of E. floribunda. Correlation analyses revealed strong connections between parameters, with 80% Aq. ethanol and acetone showing the highest correlation values (r and R2), indicating their exceptional polyphenol extraction and antioxidant potential. The principal component analysis emphasized the pharmaceutical potential of WEPs, particularly E. floribunda's 80% Aq. ethanol extract due to its phenolic and polyphenolic content. In conclusion, 80% of ethanol extracts of these plants outperform synthetic derivatives in antioxidant activity, making them promising for pharmaceutical and drug product development with enhanced natural antioxidant properties.

Statistical Applications in Pharmaceutical Product Development: A Comprehensive Review

The pharmaceutical industry often depends on statistics to improve product quality, optimize the compositions, streamline operations, and conform to regulatory requirements. In Bio Equivalency investigations, Statistics plays an integral role in decision-making while demonstrating the similarity between the test and reference products. In this review, we explore how statistics play a crucial role in pharmaceutical product development. We start with examining experiments, where statistics help scientists find the best combinations of ingredients and manufacturing conditions. We explored different types of experiments, like factorial designs, Plackett-Burman designs, Box-Behnken designs, and Taguchi designs. While optimizing the formulations and process parameters, these methodologies assist researchers in making meaningful conclusions supported by statistical inference. The next sections include Response Surface Methodology (RSM) and Mixture Designs, which help in the development of drug formulations and the comprehension of complex responses. The development of pharmaceuticals is made simpler by these approaches. Then, we examine optimal designs like A-optimal, I-optimal, and D-optimal. A-optimal designs save resources, I-optimal designs focus on precise estimates, and D-optimal designs are great for screening and getting accurate results. These designs help scientists make decisions based on data. The starting point for demonstrating dissolution similarity between generic and reference products is the statistical approach. This paper examines the use of model-dependent techniques, such as zero-order, first-order, Higuchi, and Weibull models, and model-independent techniques such as F1, F2, Bootstrap, MSD, and PCA techniques, it analyzes important parameters and bounds that are essential for determining the dissolution similarity. In the field of biostatistics, we discuss how statistics ensures that generic drugs are safe and work just as efficiently as brand-name drugs. Both regulatory approval and patient safety rely on this. We briefly discuss statistical process control (SPC) in closing. SPC checks that drugs/drug products are consistently of quality using graphs and figures. It facilitates the production of consistently effective pharmaceuticals by organizations. Advanced statistical techniques, including data mining, machine learning, and artificial intelligence, are revolutionizing the pharmaceutical industry. These tools enhance drug discovery, optimize manufacturing processes, and pave the way for personalized medicine. As real-time monitoring and predictive analytics become integral, the future holds exciting possibilities for improving patient outcomes. This review shows how statistics are like a guiding tool in the pharmaceutical industry. Whether it's in the lab or in manufacturing, statistics play a big role in making sure patients get the best medicines possible.

Analysis of US Food and Drug Administration new drug and biologic approvals, regulatory pathways, and review times, 1980–2022

U.S. laws enacted since 1983 have aimed to enhance the development and marketing of new pharmaceutical products. We thoroughly characterized all new molecular entities, therapeutic biologics, and gene and cell therapies approved by the US Food and Drug Administration (FDA) during the period 1980–2022 in the context of these laws and regulations. Throughout the study period, the FDA approved 1355 new pharmaceutical products. The median FDA review time decreased from 26.6 months prior to the Prescription Drug User Fee Act (1992), which authorized the FDA to collect fees from drug companies to 9.9 months after the Food and Drug Administration Safety and Innovation Act (2012), which created new designations that eliminated the requirement for evidence of added therapeutic benefit for FDA expedited drug review. The greatest increase in approvals occurred in antineoplastic and immunomodulating drugs, biologics, and orphan drugs. More than half of new drug approvals benefited from regulatory designations and pathways that did not require addressing unmet medical needs or demonstrating therapeutic benefit over available alternatives. The legislative goal of bringing more drugs to the market faster has been achieved. Further studies are needed to determine the therapeutic value to patients of new drugs approved using expedited approval pathways.

Artificial Intelligence in Pharmaceutical Products Development

The abstract highlights the transformative role of Artificial Intelligence (AI) in drug discovery, covering key aspects such as de novo drug design, synthesis planning, and the future implications of AI in pharmaceutical research. It begins by emphasizing AI's significant impact on drug discovery, particularly in applications like virtual screening and drug design. The survey provides a detailed overview of drug discovery, focusing on molecular property prediction and molecule generation. It explores essential components like data resources and benchmark platforms. The chronological organization of AI techniques showcases the historical evolution of AI in drug discovery. The abstract further discusses AI's applications in the pharmaceutical lifecycle, manufacturing, and post-market surveillance. It concludes by projecting the future role of AI in drug discovery, emphasizing precision medicine, personalized experiences, and collaborative efforts between AI and human researchers

Identification of a novel oligopeptide from defatted walnut meal hydrolysate as a potential neuroprotective agent.

Free radical damage and oxidative stress are thought to play a crucial role in the development of neurodegenerative diseases. Walnut peptides, especially walnut oligopeptides, have been shown to protect nerve cells from oxidative stress and inflammatory damage, as well as improve memory function. In this study, walnut peptides were obtained from walnut meal through enzymatic hydrolysis, ultrafiltration, and gel filtration chromatography. A novel oligopeptide called AQ was successfully isolated and its chemical structure was identified as AASCDQ using ESI-MS/MS. AQ demonstrated remarkable scavenging activity against O2- free radicals (81.00%), DPPH free radicals (79.40%), and ABTS free radicals (67.09%) at a concentration of 1 mg mL-1. Furthermore, AQ exhibited strong neuroprotective effects against hydrogen peroxide-induced damage in SH-SY5Y cells, reducing cell injury and apoptosis. AQ also effectively inhibited the secretion of pro-inflammatory factors NO (IC50 = 46.03 ± 0.32 μM) and suppressed the expression of IL-6 and TNF-α in RAW264.7 cells stimulated by LPS. In vivo experiments demonstrated that AQ promoted angiogenesis in the quail chick chorioallantoic membrane assay and reduced ROS accumulation in Caenorhabditis elegans, thereby extending its lifespan. The anti-inflammatory mechanism of AQ was further confirmed by western blotting. In summary, the novel oligopeptide AQ possesses potential neuroprotective effects, including antioxidant, anti-inflammatory, angiogenic, and anti-aging properties, making it a promising candidate for the development of functional foods and pharmaceutical products.

Controlling the diffusion of small molecules from matrices processed by all-aqueous methodologies: towards the development of green pharmaceutical products

This work provides a review of green approaches for producing drug delivery systems (DDSs) to identify the challenges in effectively retaining and further releasing low molecular weight molecules from all-aqueous matrices.

Zn Fortification Influential Impact on the Productivity of Calocybe indica Mycelium

Calocybe indica is an edible medicinal mushroom, preferably eaten for its culinary value. It was cultivated for its higher nutritional value, medicinal properties, and high polysaccharide content, especially glucan. Some particular minerals were enriched in food substitutes, an alternative to fighting against some targeted human ailments. Thus, mineral fortification is accessible in the submerged cultivation of mushrooms to produce bioactive compounds and fortified mushrooms. In this study, the submerged cultivation of C. indica was performed to make exopolysaccharides (EPS) using a supplemented medium of Zinc with varying concentrations. Thus, research revealed that the Zn fortification enhances the production of EPS and mycelial biomass after 21 days of incubation. The maximum mycelial biomass was 7.7133±0.30 g/L (dry weight), and the highest 0.3853±0.006EPS was produced in the 175mg/L mineral concentration, respectively. The present study revealed that the Zn supplementation gradually increased the mineral concentration and directly influenced the yield of mycelial biomass and EPS production. These EPS have various biological activities and can be helpful for fortified food or pharmaceutical product development in the medicinal and pharmaceutical sectors.