Journal of Drug Delivery and Therapeutics (JDDT)
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Formulation of Functional Food Supplements: Case Study of Manufacturing Process Optimization at ‘Sarepta Production’, Burkina Faso
Get PDFIntroduction: In the context of promoting local resources and achieving food sovereignty, plant-based food supplements play a key role. However, their production often remains artisanal, making them prone to contamination and quality inconsistency.
Objective: This study aimed to harmonize and standardize the manufacturing practices of four dietary supplements produced at the “Sarepta Production” unit in Ouagadougou, Burkina Faso, by integrating Good Manufacturing Practices (GMP) and Good Hygiene Practices (GHP).
Methodology: Standard Operating Procedures (SOPs) were developed for each stage of the production process. Microbiological analyses were carried out on three successive batches at Agence Nationale pour la Sécurité Sanitaire de l’Environnement, de l’Alimentation, du Travail et des produits de santé (ANSSEAT) using standards established by the International Organization for Standardization (ISO standards) to assess sanitary quality.
Results and Discussion: The results showed a progressive reduction in total aerobic mesophilic flora, yeasts, molds, and thermotolerant coliforms across the three production cycles. No pathogenic microorganisms like Salmonella, E. coli, or S. aureus were detected. The implementation of GMP, GHP, and Hazard Analysis and Critical Control Points (HACCP) principles enabled effective control of critical points, such as raw material reception, mixing, packaging, and storage.
Conclusion: This study demonstrates that strict integration of hygiene and quality standards within small-scale food supplement manufacturing units significantly improves microbiological safety and consumer acceptability. It offers a reproducible model for other local food initiatives in sub-Saharan Africa in general and in Burkina Faso in particular.
Keywords: Food Supplements, Good Manufacturing Practices, Microbiological Quality, Harmonization, Local Production, Critical Control Points
Toxicity assessment of a phytomedicine based on an almond extract from the fruit of Balanites aegyptiaca (L.) DELILE (Zygophyllaceae) intended for helminthiases care in Burkina Faso
No full textBalanites aegyptiaca (L.) Delile (Zygophyllaceae) is a medicinal plant used in traditional medicine in Burkina Faso to treat helminthiasis. Using an ethnopharmacological approach, the "Institut de Recherche en Sciences de la Santé (IRSS)" has developed a phytomedicine based on an almond extract from the fruit of this plant for the treatment of helminthiasis. This study aimed to assess the acute and subacute oral toxicity and in vivo mutagenicity of phytomedicine. The acute toxicity study was carried out following OECD guideline 423 by administering a single dose of 2000 mg/kg body weight (bw) of phytomedicine orally to female mice. For subacute toxicity, OECD guideline 407 was used. Four batches of 10 rats (5 males and 5 females) were used, including a control batch and three treated batches receiving a daily oral administration of the phytomedicine at doses of 250, 500, or 1000 mg/kg bw for 28 days. The mutagenicity test was performed according to OECD guideline 474; five batches of 10 mice (5 males and 5 females) were given oral doses of 500, 1000 or 2000 mg/kg bw of phytomedicine, colchicine as a positive control at 5mg/kg bw and distilled water as a negative control. In the acute toxicity test, the LD50 was estimated at 5000 mg/kg bw. The subacute toxicity study showed no mortality or signs of toxicity in rats. Biochemical analysis revealed no significant differences between control rats and those treated with the phytomedicine for glucose, creatinine, total cholesterol, triglycerides, AST, chlorine, calcium, and potassium. On the other hand, serum levels of ALT, total protein, PO43-, and Na+ were significantly reduced in some treated rats. The mutagenicity test showed no change in micronucleus frequency between treated and control mice. This study showed that phytomedicine based on an extract of B. aegyptiaca fines would present less danger to users.
Keywords: Balanites aegyptiaca, acute toxicity, subacute toxicity, micronucleated erythrocytes, phytomedicine
Design and Characterization of Aceclofenac-Loaded Microballoons using Eudragit with Hydroxypropyl Methylcellulose
No full textBackground: Drug delivery systems based on microballoons are one of the promising approaches for gastric retention, especially useful for drugs with site-specific absorption in the stomach. The microballoons are hollow, spherical particles under 200 micrometers, designed to float in the gastric environment. The Aceclofenac formulation of an NSAID is helpful with a half-life of 4–4.3 hours; this delivery form gives a sustained release and maintains constant plasma levels with enhanced bioavailability and decrease in dosing frequency.
Methodology: Microballoons of Aceclofenac were prepared using Eudragit RS 100 and Hydroxy Propyl Methyl Cellulose as polymers from the emulsion–solvent diffusion method. In this, the polymers impart stability along with a profile of controlled release. Here, the microballoons was evaluated for physical parameter and the release profile regarding average particle size, floatation percentage, entrapment efficiency, true tapped density, and percentage yield, and FTIR will be carried out on complexes of drug and polymer.
Results and Discussion: The prepared microballoons exhibit excellent floating properties and uniformity in size, which aided in long gastric retention. High entrapment efficiency with controlled and sustained release of the drug for an extended period was obtained. FTIR studies indicated that Aceclofenac remained stable in the polymer matrix with no considerable chemical interaction between the drug and the polymers.
Conclusion: This research shows promise in microballoons-based delivery systems that could maintain the release for a longer duration from the delivery device with respect to Aceclofenac, which enhances bioavailability and reduces dosing frequencies.
Keywords: Aceclofenac, Microballoons, NSAID, Sustain Release Medication, Eudragit RS100, HPM
Ayurveda Approaches for Management of Chronic Secondary Amenorrhoea Complexed with Hormonal Replacement Resistance, PCOD, and Thyroid Dysfunction: A Comprehensive Case Analysis
Get PDFAyurvedic protocols offer a holistic approach in managing Female pathologies by targeting the underlying imbalances in the HPO axis. In gynecological practices, hormonal therapy is a common approach for management of secondary amenorrhea associated with Polycystic Ovary Disease (PCOD), thyroid dysfunction, which interfere with endocrinal system and hypothalamic-pituitary-ovarian (HPO) axis. The present case involves secondary amenorrhea, which has persisted for 8-10 years, compounded by resistance to hormonal replacement therapy, thyroid dysfunction and polycystic ovary Disease (PCOD) present from 10-11 years. Initially, the menstrual cycle interval increased to 4-5 months, then over a period natural menstruation ceased and remain responsive to withdrawal bleeding for about 2 years but later patient become irresponsive to withdrawal bleeding even after usage of hormones. The Ayurvedic approach emphasizes individualized treatment plans that address both the symptoms and the root causes of these conditions. The treatment regimen included Shodhana Chikitsa, specifically Basti and Nasya, in conjunction with oral medications. Over the course of one year, the patient experienced gradual improvement. Initially, menstruation resumed naturally after a 6-month interval, followed by 2 months, and eventually at interval of 35-40 days with improved regularity and quality of bleeding. This transition marked a shift from amenorrhea and withdrawal bleeding to irregular and then to regular menstrual cycles by Ayurveda treatment.
Keywords: Amenorrhoea, Ayurveda, Basti, Nasya, Hormonal therapy, Withdrawal bleedin
A Comprehensive Review of Evidence and Challenges in Switching from Originator Drugs to Biosimilars of Monoclonal Antibodies: Focus on Rituximab and Trastuzumab
No full textObjective: The primary objective of the document is to conduct a comprehensive review of the clinical, economic, and regulatory evidence regarding the transition from originator drugs to biosimilars of monoclonal antibodies, focusing specifically on rituximab and trastuzumab. The review aims to analyze data on biosimilar usage, assess barriers to adoption, explore potential strategies to overcome challenges, with the ultimate goal of improving healthcare sustainability and accessibility.
Data source Study selection: The study selection includes clinical trials, economic analyses, and regulatory reviews focusing on biosimilars of rituximab and trastuzumab. It focuses on phase 3 trials, cost-effectiveness studies, and post-marketing surveillance data for assessing safety, efficacy, and adoption barriers. Real-world evidence and regulatory guidelines from agencies such as EMA and FDA are also considered.
Summary: The article reviews the transition from originator monoclonal antibody drugs to biosimilars, focusing on rituximab and trastuzumab. Topics of clinical evidence, economic benefits, regulatory challenges, and adoption barriers include issues related to immunogenicity concerns and perceived physician-patient acceptance. While offering potentially cost-effective treatments for cancer, further research, harmonization of regulations, and education will allow this value to be realized across more patients, improved outcomes.
Conclusion: The transition from originator drugs to biosimilars, like rituximab and trastuzumab, enhances treatment accessibility and affordability. Clinical evidence supports their safety and efficacy, but challenges remain, including immunogenicity concerns, regulatory differences, and stakeholder perceptions. Addressing these barriers through global harmonization and education can optimize biosimilar adoption and healthcare sustainability.
Keywords: Rituximab, Trastuzumab, Biosimilars, Switching, Monoclonal Antibodies
Non-Pharmacological Management of Heamorrhoids (Bawāsīr) in Unani System of Medicine: A Systemic Review
Get PDFBackground: Haemorrhoids, commonly known as (Bawāsīr), constitute a prevalent anorectal disorder characterized by painless rectal bleeding during defecation, often accompanied by prolapsing anal tissue. While several treatment modalities exist, this study focuses on the preventive aspect through Ilāj bi’l Ghidhā’ (dietotherapy), as suggested by Unani medicine. The aim is to review available data and insights from traditional sources. Haemorrhoids, recognized as a lifestyle disorder, are frequently associated with dietary habits prevalent in communities adhering to a Western-style diet, characterized by refined oils and low-fiber content. Despite the pervasive nature of haemorrhoids, their exact ethology remains elusive, surrounded by various myths and misconceptions.
Methods: A systematic literature search was conducted using specific keywords related to haemorrhoids, lifestyle disorders, and dietotherapy. PubMed, Medline, and the Cochrane Library were utilized to extract information from Unani medicine sources and ancient texts.
Discussion: Unani physicians attribute haemorrhoids primarily to sawdāwī mādda (matter), often stemming from the consumption of hot drugs and spicy foods. Key figures like Zakariyyā Rāzī and Ibn Sīnā underscore the role of excessive sawdāwī and sweet substances in haemorrhoid development. Ibn Sīnā recommends easily digestible foods, emphasizing moong ki daal, moong ki khichri, khurfa, kaddu, and mutton soup with minimal spices for haemorrhoid patients. Surgical resection is suggested as a last resort by various Unani physicians, including Abū Bakr Muḥammad ibn Zakariyyā Rāzī, ‘Alī ibn ‘Abbās Majūsī, and Hakim Ajmal Khan.
Conclusion: Unani system of medicine provides a comprehensive approach to ‘Ilāj bi’l Ghidhā’ (dietotherapy) for preventing and managing haemorrhoids. Dietary modifications, including the consumption of easily digestible and cooling foods, emerge as valuable components of this approach. This study contributes to our understanding of traditional Unani practices in preventing and managing haemorrhoids, offering insights for contemporary healthcare strategies. Further research and clinical trials are warranted to validate the efficacy of these dietary recommendations in preventing haemorrhoids and improving overall anorectal health.
Keywords: Haemorrhoids, Bawāsīr, ‘Ilāj-bi’l-ghidhā’, Dietotherapy, Non-pharmacological, ‘Ilāj-bit-Tadbīr, Regimenal therap
Peel Seeds in Functional Food Innovation: A Review on Their Use in Protein Bars
Get PDFThe increasing demand for convenient and nutritious food options has led to the development of high-nutrient protein bars as potential meal replacements. These bars are formulated to provide a balanced mix of protein, carbohydrates, healthy fats, and essential vitamins and minerals. This review aims to evaluate the efficacy and safety of high-nutrient protein bars as meal replacements. A comprehensive literature review was conducted to identify relevant studies that investigated the nutritional and health outcomes of consuming these bars. The results suggest that high-nutrient protein bars can serve as a convenient and effective approach to support weight management, improve muscle function, and enhance overall nutrition. However, the quality and safety of these products can vary significantly depending on their ingredients, manufacturing processes, and labeling claims. Therefore, it is essential to critically assess the nutritional content and safety of high-nutrient protein bars before recommending them as meal replacements.
Keywords: Protein bars, Weight management, Muscle function, Nutritional adequacy, Protein supplements, Meal alternatives
Novel Nanocarriers Microencapsulation: Current, Patents and Clinical Trials Comprehensive Review
Get PDFThe field of nanocarriers and microencapsulation has witnessed substantial growth, offering innovative solutions for drug delivery challenges. This comprehensive review explores the latest advancements in nanocarriers and microencapsulation technologies, focusing on their applications in enhancing drug stability, controlled release, and targeted delivery. The article highlights key breakthroughs, emphasizing their significance in addressing therapeutic inefficacies. A detailed analysis of current patents underscores the innovative strides in this domain, while insights into clinical trials provide a perspective on the translational potential of these technologies. This review article begins with a fundamental overview of microencapsulation, including its various types and characteristics. It intermediately delves into several formulation techniques associated with microencapsulation, examining the latest developments in prepared formulations, granted patents, and a selection of marketed products. Finally, the article addresses future prospects and the challenges that lie ahead in this field.
Keywords: microencapsulation; entrapment; microcapsules; nanocarriers; advancements
Antiretroviral drug resistance in HIV-1 patients on first-line therapy or untreated across five treatment centers in Yaounde\u27s Centre Region, Cameroon
Get PDFAntiretroviral therapy (ART) improves HIV survival. However, as ART programs expand in resource-limited settings like Cameroon toward UNAIDS 95-95-95 goals, monitoring drug resistance is critical. This study investigated HIV-1 subtypes and resistance mutations in Yaoundé, Cameroon. From 2017 to 2021, 231 HIV-positive individuals (treatment-naïve and ART-experienced patients with virological failure [viral load >1,000 copies/mL]) were enrolled across five clinics. Plasma samples were sequenced for reverse transcriptase (RT) and protease (PR) genes. Participants were predominantly female (67.5%), aged 21–35 years. Over half (58.5%) received ART (median duration: 6 months). High median viral load (536,263 copies/mL) indicated poor suppression. CRF02_AG dominated (64.5%), followed by A1 (11.7%) and G (6.9%). Resistance mutations were detected in 18.2% of ART-experienced and 13.4% of treatment-naïve participants, indicating acquired and transmitted resistance. NNRTI resistance occurred in 6.1% (ART-experienced) and 1.3% (naïve); NRTI mutations were rare (0.4%). Key mutations included M184V (NRTI) and K103N (NNRTI). Protease inhibitor (PI) resistance was prevalent (19.5%), with I54V most common. Notably, PI resistance was detected in treatment-naïve individuals. CRF02_AG dominance and high resistance rates underscore challenges to ART efficacy. Significant PI resistance in untreated patients suggests transmission of resistant strains. These findings highlight urgent needs for enhanced resistance surveillance and optimized ART strategies in Cameroon.
Keywords: First-line antiretroviral therapy, HIV-1 drug resistance, viral subtype, transmitted drug resistance, Centre, Transversal stud
Formulation And Evaluation of a Polyherbal Syrup for Anti-Inflammatory Activity
Get PDFThe increasing demand for natural remedies has led to the development of polyherbal formulations with potent therapeutic effects. This study aims to formulate and evaluate a polyherbal syrup using Moringa leaf and Curcumin for their synergistic anti-inflammatory properties. Moringa leaves, known for their rich bioactive compounds, provide antioxidant and anti-inflammatory effects, while Curcumin, the active compound in turmeric, is renowned for its potent anti-inflammatory and analgesic properties. The polyherbal syrup was formulated using a combination of these two ingredients, with appropriate excipients to enhance stability, palatability, and bioavailability. The formulation was evaluated for parameters including pH, viscosity, taste, stability, and antimicrobial activity. The results suggest that the polyherbal syrup shows promising anti-inflammatory potential, with enhanced therapeutic effects when compared to individual components. This formulation offers a natural, safe alternative for the management of inflammation-related conditions.
Keywords: Polyherbal syrup, Moringa leaf, Curcumin, Anti-inflammatory, Natural remedies