Product Quality Standards Research Articles

Unraveling the pharmaceutical footprint and risks of combining different aquaculture modes and tailwater treatment systems

Aquatic environments serve as repositories for pharmaceuticals, and intensive aquaculture is becoming a significant contributor to the discharge of aquaculture wastewater. The cyclical footprint of pharmaceuticals between the aquatic environment and aquaculture has emerged as a global concern. The environmental occurrence and risk assessment of pharmaceuticals in the aquatic environment via various aquaculture modes, as well as the pharmaceutical removal efficiency in different tailwater treatment systems, have been studied through yearly investigations. Thirty-four pharmaceuticals were detected in the aquaculture environment, and the dominant pharmaceuticals were enrofloxacin, sulfamethoxazole, amantadine, and florfenicol. The highest concentration of pharmaceuticals was found in the fish pond (3826 ± 29.6 ng/L) under the greenhouse aquaculture mode, especially in the early and late aquaculture stages, and the same trend was observed in the pond aquaculture mode. The tailwater removal efficiency was greater in summer months than other months, and the treatment efficiency of the recirculating treatment system was more stable. During the aquaculture period, a low risk was observed for most pharmaceuticals, except for enrofloxacin, sulfamethoxazole, ciprofloxacin and ofloxacin, which had at medium to high risk. High-risk pharmaceuticals show a high potential to contaminate the surrounding aquatic environment and adversely affect associated biota. Reassuringly, the ecological risks of the detected pharmaceuticals can be effectively reduced after tailwater treatment. This study provides valuable data for the growing system to assess risk in aquaculture and serves as a reference to establish quality standards for aquatic products.

Проблемні питання забезпечення якості дорожньо-будівельних матеріалів та виробів в контексті особливостей їх сертифікації в Україні відповідно до ДСТУ EN ISO/IEC 17065:2019 та закону України «Про надання будівельної продукції на ринку»

Introduction. The article examines the importance of certification of road construction materials as one of the main tools for ensuring their quality. Problems. The authors emphasize that the certificate of conformity is a key document that confirms that the products meet the established regulatory requirements. Product certification, which includes laboratory tests and control of the production process, ensures the objectivity of quality assessment. The article describes in detail the stages of the certification process, from submitting an application to technical supervision of certified products. The role of certification bodies, which must be accredited by the National Accreditation Agency of Ukraine (NAAU), is emphasized separately, and their responsibility for the safety and quality of certified road construction materials is also noted. The authors also draw attention to the problem of non-compliance with the quality standards of road construction products in Ukraine, which leads to road defects, such as cracks and subsidence, which can appear already a year after the road is put into operation. In this context, it is emphasized the need to strengthen the quality control of both produced in Ukraine and imported road construction materials. The article also considers the issue of voluntary certification of road construction products, which is carried out at the initiative of the manufacturer or supplier, which is becoming more and more important in the conditions of tender procurement. At the same time, the lack of quality control of products sold through retail networks and the lack of effective quality control of imported road construction materials are emphasized.

Kurasi Produk UMKM Kabupaten Probolinggo dalam Meningkatkan Daya Saing di Pasar Retail Modern

This MSMEs product curation assistance is motivated by the many potential MSMEs in Probolinggo Regency that have not been optimally developed. The purpose of this curation is to encourage MSMEs in Probolinggo Regency to compete in modern and even export markets. In addition, curating products for MSMEs can ensure that these products meet the quality and feasibility standards required by consumers. This curation assistance is a collaboration between Business Center at the University of Nurul Jadid, Rumah Kurasi, and the Probolinggo District Office of Cooperatives, Micro Enterprises, Trade and Industry. There were 20 business participants who participated in the product curation assistance. The curation process begins with product photos for digitalization needs, interviews, then giving a curation report. The curation results show that 14 MSMEs have modern market qualifications and 6 MSMEs have traditional market qualifications. The output of this curation assistance is a “Business to Business (B2B) - Business Matching” event or bringing together Probolinggo District MSMEs with buyers from shops, retail, restaurants and souvenir centers throughout Malang held at the Malang Creative Center. They will select suitable products to be sold in their stores based on the buyers' wishes and product quality standards.

Analysis of apple chips business development strategies using business model canvas approach and SOAR-AHP method

The study focuses on SMEs X, a producer of various processed fruit products, primarily apple chips. The business experienced a 90% decline in revenue due to an 8-month market closure during the Covid-19 pandemic, with ongoing challenges such as reduced revenue and production capacity post-pandemic. This study aims to identify business models in SMEs using the Business Model Canvas (BMC) approach, develop alternative business strategies through SOAR analysis of BMC elements, prioritize these strategies using the Analytical Hierarchy Process (AHP) method, and enhance their BMC. Four expert respondents participated in the study. The research results highlight the current business conditions across the 9 BMC elements. The SOAR matrix produced eight alternative strategies, prioritized using the AHP method, including optimal production planning and scheduling (OR2), strengthening apple chips brand awareness (OA2), disseminating freeze-drying production technology innovations (OA1), developing business unit production (SA2), expanding the marketplace (SA1), maximizing the use of social media (OR1), product quality standardization (SR1), and forming partnerships with other fruit chip SMEs to innovate freeze-dried products (SR2). The BMC was further developed by integrating SR2 and OA1 into the key partnerships element, SA2 into the key resources element, OA2, OR1, and OA2 into the key activities element, SR1 into the value proposition element, and SA1 into the channel element.

Indang Konektayo Kiosk: An Interactive Menu System for Tourists

Every traveler wants to experience hassle-free and safe travel while maintaining an enjoyable journey with the help of user-friendly interfaces and an innovative technological menu system. An interactive information menu system that improves the traveler experience, commercial operations, and tourism information at the Municipality of Indang. It is a technological solution that is relevant to today's demand and interest, and that is readily available data sources and information, which benefit. Specifically, it possesses the following characteristics, including: (1) a place finder that provides registered places in Indang with the right information and allows users to discover new established places in Indang; (2) mapping routes that provide directions and generate routes; and (3) sending the Google Maps URL through a short messaging system (SMS) to the mobile phone of the user, which can be opened in digital maps such as Google Maps. The descriptive method of research was used in this study and was created with Cascading Style Sheet (CSS), Hypertext Markup Language (HTML), Hypertext Processor (PHP), JavaScript (JS) in web development, MySQL for its database, as well as an SMS API for sending map URLs based on the queries. The Agile software model was used, which was composed of sprints, each of which was meant to focus on the developmental adjustments as interactive kiosks were prone to updates and ran into serious changes. Using ISO 9126 software product quality standards, the system received an average rating of 4.71 from respondents, indicating excellent quality and that it served its functions properly and met all of the required requirements.

Evaluation of entropy-coupled multi-criteria decision-making methods for enhancing machinability

Optimizing machining parameters is crucial, enhancing machinability while maintaining high product quality standards. This study bridges a critical research gap by evaluating and comparing five Taguchi-based Multi-Criteria Decision Making (MCDM) techniques—Combined Compromised Solution (CoCoSo), Grey Relational Analysis (GRA), Multi-Objective Optimization Ratio Analysis (MOORA), Technique for Order Preference by Similarity to Ideal Solution (TOPSIS), and Complex Proportional Assessment (COPRAS)—coupled with the Entropy method to optimize machining parameters for enhancing machinability in turning medium carbon steel. The focus is on feed rate and cutting speed under dry and Minimum Quantity Lubrication (MQL) environments considering six critical machining responses: material removal rate, surface roughness, main cutting force, cutting temperature, cutting ratio, and tool life.The results reveal that MQL consistently improves machining performance, with COPRAS, TOPSIS, MOORA, and GRA converging on an optimal setting favoring an MQL environment, a 0.14 mm/rev feed rate, and a cutting speed of 137 m/min, whereas CoCoSo suggests a different optimal parameter setting. CoCoSo and GRA demonstrate the highest reliability, evidenced by minimal discrepancies between predicted and experimental results, with absolute percentage errors of 0.647 % and 0.659 %, respectively. The COPRAS method also shows strong predictive accuracy with a 5.573 % error, outperforming MOORA and TOPSIS. Spearman's rank correlation analysis reveals a high agreement between COPRAS, MOORA, and TOPSIS, with COPRAS emerging as a potential replacement for the latter in similar decision-making scenarios. SEM and EDX analyses confirm that MQL conditions reduce tool wear, enhance surface quality, and extend tool life compared to dry machining. This research provides insights into effective parameter optimization strategies for improving machinability and underscores the benefits of adopting MQL for sustainable manufacturing processes.

ANALYSIS OF THE USE OF INTERFACING TYPES ON THE QUALITY OF VESTS

This research aimed to determine the characteristics of cufner, mori gula, and tricot as interfacing on semi-silk material of Corak Insang Pontianak fabric, the quality of vest products used semi-silk material of Corak Insang Pontianak fabric with cufner, mori gula, and tricot. The type of research was descriptive exploratory with a survey approach. The subject of this research was a vest design using semi-silk materials of Corak Insang Pontianak fabric with three types of interfacing. The study was repeated three times tests. Data collection used observation sheets by expert and trained panelists. Aiken’s V values were 0.94, and Cronbach's Alpha was 0.762, meaning the instrument was valid and reliable. Quality indicators were measured from surface flatness, adhesion strength, surface texture, material fall, and total look. The results of the quantitative data were analyzed using a descriptive test. The results showed that the characteristics of cufner as interfacing on semi-silk material of Corak Insang Pontianak fabric was more appropriate to be used on vest, because it could support product quality standards very well compared to mori gula and tricot; The quality of vest products used semi-silk material of Corak Insang Pontianak fabric with cufner got a percentage value of 88% with an excellent category, mori gula 70% with a suitable category, and tricot 78% with a good category. It could be concluded that interfacing gave the best results based on the indicators of product quality assessment of vests using semi-silk materials compared to tricot and mori gula.

“Emerging Occupational Risks in a Pharmaceutical Company Under Industry 4.0: An Assessment Using TICHNER and HIRAC Tools”

Abstract: The integration of Industry 4.0 technologies within the pharmaceutical manufacturing sector aligns with broader industrial objectives, aiming to enhance productivity and adaptability while meeting challenging standards for product quality and diversity while maximizing efficiency. However, this shift is not risk-free. This particularly concerns the well-being of workers which is one of the top concerns shared by manufacturers. As the industry navigates this transition, it is imperative to prioritize the safety of personnel. The rapid pace of technological innovation within pharmaceutical manufacturing carries significant implications, introducing new and emerging risks. Consequently, proactive identification and assessment of these potential threats are essential to effectively mitigate their impact and ensure preparedness for forthcoming changes. To address this gap, this study provides an approach for identifying potential sources and significant factors contributing to its increasing risks in implementing Industry 4.0 in manufacturing industries. This set of sources and factors was evaluated in a medium-sized pharmaceutical manufacturing company aided by TICHNER and HIRAC Tools through a mixed-method approach. The combination of these tools facilitates the identification, characterization, and analysis of new and emerging risks associated with Industry 4.0 implementation. The findings of the study showed that Psychosocial Hazards and Work Experience/ Knowledge are the most common potential sources of Psychological Risks, Unemployment, and Need for Qualified Workers. The approach will allow manufacturers to proactively manage the new and emerging challenges brought by Industry 4.0 and safeguard the well-being of the workforce.

The Effects of High-Pressure Processing Pre-Treatment on Apple Fruit for Juice Production.

One of the most difficult issues in the juice industry is to manufacture juices where processing processes minimise the impact on the native characteristics of the fruits. In this study, high-pressure technology was used on whole apple fruits in order to evaluate the effect on the juice production. Two varieties, cv. Limoncella and cv. Pink Lady, were considered. Preliminarily, the fruits were subjected to different pressures, and histological as well as pomological measurements were taken in order to identify the best treatment condition, which was established to be 600 MPa for 3 min. Juice samples were then characterised by measuring the colour, viscosity, total antioxidant capacity (TAC), and total phenolic content (TPC). The storage colour stability of the juices for both varieties showed not significant L* values between the untreated and pre-treated fruits. Juices obtained from pre-treated fruits had a viscosity significantly higher than that obtained from untreated ones. Interestingly, the TPC of high-pressure processing (HPP) pre-treated juice resulted in being significantly higher compared to the untreated ones. The HPP pre-treatment can be considered as a commercial application to modulate some quality standards for apple juice production.

УПРАВЛІННЯ ЗМІНАМИ НА ПІДПРИЄМСТВАХ МОЛОКОПРОДУКТОВОГО СЕКТОРУ УКРАЇНИ

The article is devoted to studying modern trends in the development of Ukraine's milk processing sector. It also reveals the level of actual dairy product consumption by the country's population. As the study results showed, it has been significantly lower than the recommended parameters in recent years. Your role in the dairy sector is crucial to addressing this issue and shaping the future of the industry. The dynamics of milk production volumes by main categories of producers were analyzed. The key structural changes in the industry's development have been identified, among which the most significant is the long-term concentration of production in the sector of small producers—households. In the modern structure of milk production, the share of households in the population is 66%, and 31% is provided by agricultural enterprises of various forms of management. The concentration of production of dairy raw materials within the household sector is accompanied by a low number of problematic issues that hold back the potential of greening, innovative development, and increasing the competitiveness of domestic dairy products. However, there is a silver lining. Strategic orientations for further management changes in the dairy sector of Ukraine's enterprises were outlined, highlighting the potential for organic dairy production. The activation of further development of organic dairy production and the greening of dairy products and trade brands were identified as critical factors. According to the current assessment, the share of organic milk production in EU countries is insignificant. This creates real prospects for Ukrainian dairy companies to increase their competitive potential in the domestic and European milk products market. Based on the research results, a list of the main characteristics inherent in organic production in the country's dairy sector was substantiated. The set of key challenges that necessitate the constant management of changes in the dairy industry enterprises are outlined. The main ones are defined as: structural disparities by category of milk producers, constant complication of dairy product quality standards by the EU, loss of the potential of domestic feed production, low paying demand of the population of Ukraine, slow pace of transformations towards greening and implementation of sustainable development initiatives of the agri-food sector of Ukraine. However, the research results also demonstrated active trends in the development of trademarks of dairy companies in Ukraine, which contributes to a more intensive formation of competitive advantages among them. These findings are crucial for understanding the current state and potential future of the dairy sector, and they also inspire hope for the industry's future.

Tanggung Jawab Hukum Bagi Produsen Obat Sirup Anak yang Berbahan Zat Berbahaya Berdasarkan Undang-Undang No 17 Tahun 2023 Tentang Kesehatan

The case shows that some children's syrup drug products contain hazardous substances that can endanger the health of children. As a producer of children's syrup, their legal responsibility is very important in ensuring consumer safety. Law No. 17 of 2023 concerning Health provides a legal framework that regulates the responsibility of producers in this regard. This thesis discusses the legal responsibility of producers of children's syrup containing dangerous substances based on the law. The research reviews legal aspects related to producer responsibility, including legal sanctions that can be given to producers if they are found to have violated regulations, as well as what efforts producers can take to minimize legal risks and meet product safety and quality standards. The results of the study show that manufacturers of syrup for children must pay attention to various regulations and safety and quality standards stipulated by Law No. 17 of 2023 concerning Health and related institutions, and conduct product trials periodically to ensure safety and quality. In addition, producers must also be prepared to face legal sanctions if they violate existing regulations, such as fines and revocation of business licenses. The legal responsibility of the producer, then legal liability, namely civil, criminal and administrative responsibility Legal efforts that can be carried out Mediation efforts with the business actor/manufacturer of children's syrup medicine, if this fails, then the process can be carried out through the Consumer Dispute Protection Agency (BPSK), if the decision is not satisfactory, further legal action can be taken through the general court. The Ministry of Health and BPOM should be able to mitigate risks at the outset, regarding the distribution of drugs in Indonesia

Factors affecting consumers intention in purchasing eco-friendly cosmetic products in Batam City

Purpose: This study aims to identify the factors affecting consumer purchase intention towards ecologically sustainable cosmetic products in Batam City. The factors examined included subjective norms, promotion, perceived behavioral control, trust, and product quality. The data comprised of 322 questionnaires. The scope of this study was confined to Batam; therefore, the findings cannot be extrapolated to other areas. Methodology: This study employed a survey to obtain data from consumers of cosmetic products in Batam. Results: The data analysis revealed that attitude, perceived behavioral control, sales promotion, product quality, and subjective standards significantly affected the intention to purchase green cosmetic products in Batam City. Nevertheless, trust does not have a significant effect on purchase intention. The findings of this study offer valuable insights for cosmetic companies to devise more efficient marketing strategies for green cosmetic products. Limitations: Data collection was exclusively conducted via questionnaires, which may have introduced respondent bias. Owing to its cross-sectional nature, this study could not elucidate temporal variations. A longitudinal study offers a more profound understanding of fluctuations in consumer intention over time. Contributions: This study validates consumer perspectives on green cosmetics and advocates for more explicit standards and regulations in the sector, and the use of sophisticated biotechnology to extract natural ingredients.

Comparative Study of Analytical Method Validation and Process Validation parameters as per ICH, EMA, WHO and ASEAN guidelines

Objective: Compare and analyse analytical method validation and process validation requirements across ICH, EMA, WHO, and ASEAN guidelines, alongside relevant literature. Summary: In the pharmaceutical industry, ensuring the quality, safety, and effectiveness of medicinal products is of utmost importance. Analytical Method Validation (AMV) and Process Validation (PV) are critical procedures in pharmaceutical manufacturing, vital for upholding product quality and adhering to regulatory standards. This thesis undertakes a comparative examination of AMV and PV guidelines from prominent regulatory authorities, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the European Medicines Agency (EMA), the World Health Organization (WHO), and the Association of Southeast Asian Nations (ASEAN). The study delves into the foundational principles, methodologies, and regulatory requirements outlined by each guideline to assess their alignment and differences. It scrutinizes key aspects such as validation parameters, acceptance criteria, documentation requirements, and statistical approaches to identify commonalities and disparities among the guidelines. Furthermore, this research aims to offer insights into the practical implications of adhering to multiple regulatory frameworks concurrently. It examines the challenges pharmaceutical companies encounter in navigating divergent requirements and harmonizing validation processes across various regions. Additionally, potential strategies to streamline compliance efforts and optimize resource allocation are explored. By synthesizing the findings of this comparative analysis, stakeholders in the pharmaceutical industry can gain a comprehensive understanding of the regulatory landscape governing AMV and PV practices. Moreover, the insights derived from this study can inform the development of harmonized validation protocols that facilitate global market access while maintaining the highest standards of product quality and patient safety. Conclusion: Notable variations exist in validation approaches, but all emphasize product quality, safety, and efficacy. Pharmaceutical companies must navigate diverse regulatory landscapes for compliance.

Benefits of knowledge sharing by farmers to encourage implementation of robusta coffee production standard

Abstract Knowledge is a valuable asset in today’s digital age. Knowledge sharing is vital in building understanding, creating creative ideas, and developing innovations that greatly benefit. Agriculture is an essential sector of the world economy, including coffee. Coffee that is cultivated and processed according to quality standards will have high quality, good taste, and be more competitive both in national and international markets. On the other hand, the practice of robusta coffee production quality standards by farmers is still not as expected. Knowledge sharing by coffee farmers will expand the range of dissemination, knowledge, and enthusiasm in implementing quality standards. This study explores the benefits of knowledge sharing from a farmer’s perspective for implementing robust coffee production quality standards. This research method is qualitative (case study strategy) and NVivo12 Plus application for analysis. The research found that the benefits of knowledge sharing felt by farmers include benefits for personal lives, social lives, coffee standard operating procedure practices, and coffee farm development. This research will add new facts about knowledge sharing by farmers and increase understanding of the impact of knowledge sharing on implementing robusta coffee production quality standards.

КРЕАТИВНИЙ МЕНЕДЖМЕНТ ЯК ІНСТРУМЕНТ ПІДВИЩЕННЯ КОНКУРЕНТОСПРОМОЖНОСТІ ПРОДУКЦІЇ ПІДПРИЄМСТВ

In the course of writing this article, an in-depth analysis of the theoretical aspects of creative management as a tool for increasing the competitiveness of enterprises' products was carried out. The article is aimed at highlighting innovative approaches to management and the creative process that contribute to effective management and stimulate the development of enterprises in the current global market environment. The essence of the concepts of creativity and creative management and their impact on the quality and innovativeness of products in the market are investigated. The place and state of innovative development in the global market environment of Ukraine, including the indicator of creative results of national enterprises, are studied. The principles of creative management, which ensure the competitiveness and sustainability of enterprises in the market, are generalized. Key creative management strategies that ensure a high level of product quality are identified. It is substantiated that the intensification of creative processes solves the production and economic challenges of enterprises, facilitating their adaptation to changing market conditions and improving product quality. The article analyzes the role of consumers in shaping product quality and reveals how their requirements and choices influence the choice of a creative management strategy. It is determined that the successful implementation of creative management requires an integrated approach and active interaction of all stakeholders of the enterprise. It is established that creative management not only contributes to raising the level and standards of product quality, but is also critical for strengthening the market position of an enterprise.

Strategy for Developing Aquaculture Villages in East OKU Regency

East OKU Regency, located in South Sumatra, is one of the largest catfish producers through pond cultivation. Recently, the Ministry of Marine Affairs and Fisheries designated East OKU Regency as a center for catfish farming, a status formally recognized by officials from South Sumatra and East OKU Regency. The catfish cultivation village spans 1,200 hectares and produces 30 tons annually. To ensure sustainable and environmentally friendly aquaculture practices, and to enhance fish farmers' incomes, effective development strategies are necessary. This research explores strategies for developing aquaculture villages in East OKU Regency. The study employs a case study method, focusing on Belitang District as a representative example of an aquaculture village in South Sumatra Province. A simple random sampling method was used to select 90 farmer groups from a population of 900 fish farmers. The research data were processed and analyzed using SWOT analysis to identify strategies for advancing fish farming villages in East OKU Regency. The findings suggest that the optimal development strategy (SO Strategy) involves providing training and skills related to technology and production systems to boost catfish output. Additionally, strengthening cultivator group institutions is crucial for facilitating the adoption of product quality standards and improving production quality to meet market demands.

Regulatory Compliance of Cosmetic Products in Kenya: A Narrative Review on Quality and Safety

This study reviews the regulatory compliance of cosmetic products in Kenya, with a focus on consumer risks and potential public health impact. A narrative review study design was employed and a literature search was conducted using government reports, publications, academic databases, and other relevant sources. Keywords such as cosmetic industry challenges and cosmetic regulation in Kenya were employed to search the literature for papers. Data focusing on regulatory frameworks, enforcement mechanisms, adverse reactions, and industry challenges was then extracted and discussed in the form of a narration. The growth of the cosmetic industry, fueled by urbanization, a rising middle class, and increased grooming awareness, has attracted both local and international investors, presenting challenges in maintaining product quality and safety standards. Seven cases of adverse reactions related to cosmetics were reported by Pharmacy and Poisons Board between 2018-2023. The current study identifies noteworthy challenges by examining Kenya’s regulatory framework, led by the Pharmacy and Poisons Board and the Kenya Bureau of Standards. Enforcement disparities within international standards, variance in regulations on prohibited ingredients, inconsistent labeling requirements, industry dynamics, and counterfeiting, compounded with the complex nature of safety assessments raise concerns for cosmetic regulators, distributors, and manufacturers. The study highlights existing gaps in regulatory oversight emphasizing the necessity of robust enforcement mechanisms. Compliance assessments by KEBS and PPB encompass the evaluation of ingredients, formulations, microbial contamination, packaging, and labeling. Factors contributing to regulatory noncompliance include poor product quality aggravated by supply chain complexities in the vast and diverse sector. The cosmetic cottage industry inadvertently presents a quality risk to consumers due to limited process and testing capacity. Reported adverse reactions, particularly to mercury-containing skin-lightening products, raise concerns about public health implications. This study advocates for continuous product monitoring and heightened vigilance. The review proposes improvement strategies, emphasizing a dynamic regulatory approach, periodic ingredient reviews, a centralized product approval system, and alignment with global manufacturing standards. Targeted consumer education initiatives focusing on product quality attributes, adverse reaction reporting, label reading, and counterfeit awareness are recommended.

STRATEGI EKSPOR PT LEGEND TREN INTERNASIONAL DALAM MEMBAWA MINUMAN LOKAL KE PASAR INTERNASIONAL

Currently, MSMEs not only market their products to the domestic market but also to the international market. One is PT Legend Tren Internasional, which brings traditional local drinks to the international market. Legen drink or siwalan sap water is a product from Tuban City that PT Legend Tren Internasional processes as a product that is low in sugar and suitable for people with diabetes. The brand image emphasized in this product is typical of the Indonesian archipelago, which is global. The research discusses the company's export strategy, which uses the concepts of product adaptation and innovation strategies, product quality standardization strategies, and export promotion strategies. This research is qualitative research with primary data sources through interviews and secondary data to find out the strategies of Legend Tren International in introducing products and exporting them to various countries. This MSME does not have competitors, so it is an opportunity to market its products internationally. They have already exported products to Hong Kong, Singapore, and Nigeria.

Quality by design approach for fabrication of extended-release buccal films for xerostomia employing hot-melt extrusion technology

The study endeavors the fabrication of extended-release adipic acid (APA) buccal films employing a quality by design (QbD) approach. The films intended for the treatment of xerostomia were developed utilizing hot-melt extrusion technology. The patient-centered quality target product profile was created, and the critical quality attributes were identified accordingly. Three early-stage formulation development trials, complemented by risk assessment aligned the formulation and process parameters with the product quality standards. Employing a D-optimal mixture design, the formulations were systematically optimized by evaluating three formulation variables: amount of the release-controlling polymer Eudragit® (E RSPO), bioadhesive agent Carbopol® (CBP 971P), and pore forming agent polyethylene glycol (PEG 1500) as independent variables, and % APA release in 1, 4 and 8 h as responses. Using design of experiment software (Design-Expert®), a total of 16 experimental runs were computed and extruded using a Thermofisher ScientificTM twin screw extruder. All films exhibited acceptable content uniformity and extended-release profiles with the potential for releasing APA for at least 8 h. Films containing 30% E RSPO, 10% CBP 971P, and 20% PEG 1500 released 88.6% APA in 8 h. Increasing the CBP concentration enhanced adhesiveness and swelling capacities while decreasing E RSPO concentration yielded films with higher mechanical strength. The release kinetics fitted well into Higuchi and Krosmeyer-Peppas models indicating a Fickian diffusion release mechanism.

Analysis on patents of health care products with substances of medicine food homology in China

ObjectiveThe concept of substances of medicine food homology (SMFH) has garnered significant attention in recent years. This study conducts a systematic analysis of patent literature related to SMFH, and elucidates the development trends, technical hotspots, and the overall patent protection landscape of SMFH in China over the past two decades. MethodsThe patent search focused on the SMFH varieties as the objects of inquiry, with retrieval conducted in patent databases. Subsequently, the acquired data underwent processing, analysis, and visualization. ResultsWhile the technical threshold for pharmaceutical applications surpasses that of the food service sector, the former may assume a prominent role in the future. Research and development (R&D) activities in the southeast of China demonstrate robust activity than other regions. Colleges and scientific research institutions exhibit substantial advantages in patent applications compared with individuals and hold greater potential for future development. ConclusionThe findings of this patent analysis indicate that China’s SMFH industry are presently undergoing a transition from an extensive model to a high-quality model. The quality and technical standards of SMFH products are consistently improving. Consequently, there is a need for more stringent patent application requirements to align with the evolving development needs.