Química Farmacéutica
Permanent URI for this collection
Browse
Recent Submissions
Item Tecnologías para la autenticación y trazabilidad de empaques farmacéuticos: Revisión sistemática(Universidad Santiago de Cali, 2026-06-02) Serna Rosas, Anderson David; Restrepo Zapаta, Jorge Humberto (Director)The counterfeiting of medicines and the adulteration of pharmaceutical packaging is a growing public health and safety problem, associated with the infiltration of counterfeit products into legitimate supply chains. This phenomenon is related to counterfeiters' ability to copy packaging, labels, identification codes, and traceability systems, jeopardizing the quality, efficacy, and safety of medicines. A systematic review was conducted following the PRISMA guidelines, focusing on emerging authentication and traceability technologies applied to pharmaceutical packaging. This involved a comparative analysis of studies addressing blockchain, RFID, NFC, QR codes, GS1 systems, photoluminescent materials, smart inks, physically non-clonable functions (PUFs), artificial intelligence, and mobile verification platforms. The included studies showed a marked trend toward the integration of multi-layered digital and physical technologies to strengthen the security of primary, secondary, and tertiary packaging. Systems based on blockchain, smart contracts, and IoT demonstrated a high capacity to ensure traceability, logistical transparency, and the detection of deviations or alterations in documentation. At the same time, advanced optical technologies such as fluorescent inks, photoluminescent materials, SPN microdots, dynamic QR codes, and PUF systems demonstrated high resistance to cloning, scan-reprinting, and sophisticated visual counterfeiting. On the operational side, both portable multispectral inspection technologies and NFC/QR mobile authentication applications have emerged as useful complementary tools for agile verification at consumer, customs, and regulatory checkpoints. In this regard, the coordinated integration of physical, digital, and regulatory systems represents a fundamental axis for strengthening the pharmaceutical supply chain and reducing the circulation of counterfeit medicines.Item Revisión sistemática sobre la influencia del conocimiento y de la percepción del riesgo en la adquisición de medicamentos falsificados, subestándar o no regulados en la población adulta(Universidad Santiago de Cali, 2026-06-02) Chavez Largo, Luz Adriana; Restrepo Zapаta, Jorge Humberto (Director)The consumption of counterfeit, substandard, or unregulated medicines represents a significant problem due to the risks associated with their use and the conditions that facilitate their acquisition. The objective of this study was to analyze the available scientific evidence on the knowledge and perceptions of the adult population regarding these types of medicines, observing how this knowledge and risk perception influence the acquisition of medicines. A systematic literature review was conducted, including 16 studies selected from various databases, applying predefined inclusion and exclusion criteria. The studies were analyzed comparatively, considering variables related to the level of knowledge, risk perception, factors associated with acquisition, and contextual differences. The results showed that, although a significant proportion of the population recognizes the existence of counterfeit medicines and their risks, this knowledge is generally superficial and does not allow for their identification in practice. Furthermore, risk perception, while present, does not act as a sufficient deterrent. It was identified that the acquisition of these medications is primarily influenced by factors such as cost, access, availability, and the use of unregulated channels, especially the internet. It was concluded that knowledge and risk perception influence acquisition, but do not directly determine behavior, as this is conditioned by contextual factors. These findings highlight the need to address this problem from a comprehensive perspective.Item La química forense y su relevancia en la detección de nuevas sustancias psicoactivas en la sangre mediante cromatografía líquida acoplada a espectrometría de masas (LC/MS)(Universidad Santiago de Cali, 2026-03-13) Palacios Gonzalez, Maria Sofia; Baños Correa, Harold Javier (Director)The growth of new psychoactive substances (NSP) has generated an increasing challenge for forensic toxicology, due to the difficulty of their detection with conventional methods and their effect on public health. This study proposed to analyze the importance of forensic chemistry in the identification of NSP in blood samples using liquid chromatography coupled to mass spectrometry (LC/MS). A systematic review was carried out following PRISMA's guidelines, looking for articles published between 2018 and 2025 in various databases such as Scopus, ScienceDirect, PubMed, Redalyc, Scielo and Google Scholar. Research was chosen that used analytical methodologies such as LC/MS, LC-MS/MS, GC-MS and immunoassays, considering aspects such as sensitivity, specificity and detection limits. The findings showed that the LC-MS/MS technique proved to be the most effectivein identifying non-volatile and thermally unstable compounds, overcoming the restrictions of immunoassays and gas chromatography. Barriers related to matrix effect, calibration and the need for trained personnel were also detected. It was concluded that forensic chemistry has a crucial role in the identification of NSP, reaffirming LC/MS as a key tool for toxicological analysis. Finally, it was suggested to improve the application of this technique in forensic laboratories in Colombia and Latin America, promote validation between laboratories and update the databases to ensure more accurate results and an efficient response to the emergence of new drugs.Item Eficacia del cannabidiol en el tratamiento de epilepsia refractaria en población pediátrica de 2 a 18 años: Revisión sistemática(Universidad Santiago de Cali, 2026-05-13) Gomez Acero, Mariana; Restrepo Zapаta, Jorge Humberto (Director)Pediatric refractory epilepsy presents a highly complex clinical challenge, characterized by resistance to multiple antiepileptic drugs and its significant impact on neurodevelopment and quality of life. This situation has driven the search for therapeutic alternatives such as cannabidiol (CBD), a molecule with mechanisms of action distinct from conventional treatments and with the potential to modulate neuronal hyperexcitability. A systematic review was conducted following the PRISMA guidelines, which included searching various electronic databases, for the treatment of refractory epilepsy in the pediatric population. The reviewed articles showed that CBD significantly reduced seizure frequency, with responder rates (≥50% reduction) between 40% and 70%, demonstrating its greatest efficacy in syndromes such as Lennox-Gastaut syndrome, Dravet syndrome, and genetic epileptic encephalopathies. On the other hand, the therapeutic response was found to depend on the dose range and co-administration with medications such as clobazam, with which a synergistic effect was observed, increasing the clinical response. From a safety perspective, cannabidiol showed a mostly positive profile; however, significant pharmacokinetic interactions were detected, especially with valproic acid and clobazam, which increased the risk of liver damage and sedation, respectively. In conclusion, the results confirmed that CBD is an effective therapeutic option for refractory epilepsy in children, but its influence on neurodevelopment and quality of life remained uncertain due to methodological heterogeneity and limitations in the assessment of these outcomes in the available studies.Item Evaluación in silico de compuestos naturales como posibles inhibidores de la enzima PARP-1 en el tratamiento de cáncer de ovario con mutaciones BRCA 1/2(Universidad Santiago de Cali, 2026-06-11) Daza López, Lina Natalia; Ciro Monsalve, Yhors Alexander (Director); Oñate Garzón, José Fernando (Director)Ovarian cancer associated with mutations in the tumor suppressor genes BRCA1 and BRCA2 exhibits homologous recombination repair deficiency (HRD), making it vulnerable to inhibition of the enzyme poly(ADP-ribose) polymerase 1 (PARP1) through the synthetic lethality mechanism. However, the development of resistance to synthetic PARP1 inhibitors limits their clinical efficacy, creating the need for new therapeutic alternatives. This study evaluated in silico the inhibitory potential of eight natural compounds (flavanones and flavonols) against PARP1, using ligand-based virtual screening based on structural similarity to talazoparib, molecular docking with AutoDock Vina, and ADME property prediction with SwissADME. Protocol validation through re-docking showed an RMSD (Root Mean Square Deviation) close to 0 Å. Affinity results indicated that naringin (ΔG = -9.280 kcal/mol; Kd = 160 nM) outperformed talazoparib (ΔG = -8.263 kcal/mol; Kd = 870 nM) and the natural substrate NAD⁺ (Nicotinamide Adenine Dinucleotide) (ΔG = -8.379 kcal/mol; Kd = 720 nM), followed by hesperidin (ΔG = -7.736 kcal/mol; Kd = 2.100 nM) and hesperetin (ΔG = -6.813 kcal/mol; Kd = 11.000 nM). Interaction analysis revealed that the glycosides naringin and hesperidin adopt alternative binding modes mediated by hydrophobic contacts and C-terminal residues of the enzyme, while smaller flavanones preserve π-π interactions with TYR689. ADME evaluation identified hesperetin, naringenin, and silibinin as the compounds with the best pharmacokinetic profile for oral administration, complying with Lipinski's rules and showing high predicted gastrointestinal absorption. Naringin and hesperidin, despite their high affinity, showed limitations for oral bioavailability due to their high molecular weight and high polarity. Based on the integrated analysis of affinity, molecular interactions, and ADME profile, naringin, hesperetin, and naringenin were selected as lead candidates, positioning them as promising candidates for future experimental studies and contributing to the development of new therapies for BRCA1/2- mutated ovarian cancer.Item Nuevas sustancias psicoactivas: Tendencias moleculares estructurales y patrones moleculares en el diseño ilícito: Revisión sistemática(Universidad Santiago de Cali, 2026-06-03) Quevedo Salazar, Santiago Alberto; Ocampo Changuendo, Dennis Mauricio (Director)New psychoactive substances (NPS) represent a growing challenge for forensic chemistry, toxicology and public health due to their rapid emergence, high structural variability and ability to evade control mechanisms, this systematic review aimed to analyze the main structural trends and molecular patterns involved in the illicit design and synthesis of NPS in the forensic context, a bibliographic search was proposed in specialized databases, considering recent publications in English and Spanish related to chemical structures, analogues, molecular modifications, analytical identification and regulation, the findings showed that NPS usually originate from incremental modifications of known molecular scaffolds, especially synthetic cannabinoids, synthetic cathinones, nitazene-type synthetic opioids, designer benzodiazepines, phenethylamines and arylcyclohexamines, changes in side chains, aromatic rings, functional groups, heterocyclic nuclei and specific substituents contribute to preserving psychoactive effects, modifying potency and hindering detection. It was concluded that structural analysis of NPS is essential to anticipate emerging substances, strengthen analytical surveillance and support regulatory strategies based on chemical families and molecular patterns.Item Evaluación in silico de las interacciones de Resveratrol, un compuesto natural multitarget, con proteínas de interés terapéutico: Una revisión sistemática(Universidad Santiago de Cali, 2026-05-28) Bejarano Oliveros, Jose Miguel; Ciro Monsalve, Yhors Alexander (Director); Oñate Garzón, José Fernando (Director)The identification of multitarget compounds with pharmacological plausibility constitutes a growing priority in Pharmaceutical Chemistry, particularly in the face of complex diseases such as cancer, neurodegenerative diseases, pulmonary fibrosis and cardiometabolic disorders, in which inflammation, oxidative stress, metabolic alterations and proliferative deregulation converge. In this context, a systematic review of the literature was carried out to critically analyze the in silico interactions of resveratrol with proteins of therapeutic interest reported between 2020 and 2025. The search was structured according to the PRISMA 2020 and PRISMA-S guidelines, and included original studies from biomedical and multidisciplinary databases that used molecular docking, molecular dynamics, network pharmacology or combined strategies. The evidence analyzed showed a consistent recurrence of signaling axes such as PI3K/Akt/mTOR, MAPK and AMPK/mTOR, as well as inflammatory nodes such as TNF, IL1B, IL6 and STAT3, along with more defined interaction targets, including CDK5, MTH1, tyrosinase and lipase. However, relevant methodological heterogeneity associated with target selection, structural preparation of receptors, interpretation of scoring functions and the absence of orthogonal validations in part of the studies was also identified. Taken together, the findings indicated that resveratrol possesses a multimodal profile with translational interest, although its current value is better understood as a chemical scaffold amenable to structural and pharmacotechnical optimization than as a fully resolved monotarget therapeutic candidate.Item Predicción In sillico del potencial antienvejecimiento de péptidos derivados de semillas de quinua mediante hidrólisis enzimática con actinidina(Universidad Santiago de Cali, 2026-06-11) Vallejo Delgado, Sofia; Ruales González, Andres David; Oñate Garzón, José Fernando (Director); Ciro Monsalve, Yhors Alexander (Director)Skin aging is associated with the degradation of the extracellular matrix mediated by enzymes such as collagenase and elastase. In this context, bioactive peptides derived from plant proteins have attracted interest due to their potential inhibitory activity against these enzymes. The present study aimed to predict, using in silico bioinformatics tools, the anti-aging potential of peptides derived from wild Chenopodium quinoa wild seeds obtained through enzymatic hydrolysis with actinidin. Peptide structures were modeled using UCSF Chimera, prepared with AutoDockTools, and evaluated by molecular docking using AutoDock Vina against the enzymes collagenase (PDB: 5B5O) and elastase (PDB: 3UVC). Interaction visualization analysis was performed using Discovery Studio Visualizer. The binding affinities of multiple peptides were favorable, with CGAYTLP and AGLQFGK standing out against collagenase. YATK and FPISNAK stood out against elastase. These findings make it possible to use quinoa-derived peptides as potential candidates for anti-aging.Item Aplicación de la tecnología NIR para análisis de la calidad del Maíz con fines de producción de almidón grado USP para la industria farmacéutica(Universidad Santiago de Cali, 2026-06-11) Giraldo Castañeda, Juan Carlos ; Castillo Ayala, Jorge Enrique (Director)Near-infrared spectroscopy (NIR) is a fast, non-destructive, and efficient analytical technique for assessing the quality of corn and USP-grade starch, key materials in the pharmaceutical industry. This literature review covers the fundamentals of NIR spectroscopy and the statistical models used to interpret spectral data. The primary calibration methods that optimize the technique's accuracy in quantifying and characterizing both qualitative and quantitative parameters of corn and USP-grade starch are analyzed. The results demonstrate that the application of NIR contributes to rigorous quality control during the production process, ensuring the purity and consistency of starch for pharmaceutical use. Consequently, NIR spectroscopy is establishing itself as a promising technological tool for enhancing efficiency and reliability in the pharmaceutical industry.Item Análisis instrumental de residuos de disparo orgánicos e inorgánicos: Una revisión sistemática(Universidad Santiago de Cali, 2026-05-26) Rios Beltran, William Camilo; Ocampo Changuendo, Dennis Mauricio (Director)When a firearm is detonated, a series of residues called gunshot residue (GSR) are released, which due to their chemical composition can be objects of investigation for forensic analysis. This systematic review took 27 recent articles in order to understand how these types of compounds are detected, until instrumental analysis results are obtained and how the expert can use this information to reach conclusions in the forensic investigation. Although the most common tool for identifying this type of compound is SEM-EDS, it emphasizes that the time variable would be the biggest constraint for obtaining results, along with innovations in the type of ammunition (lead-free, heavy metal-free), where compounds other than those of common nations are found, leads to the mention of a series of methodologies as alternatives, which alone or complemented between them and other chemometric techniques or analysis, may be a viable option for the analysis of these new components. It was concluded that although modern techniques offer promising solutions, a number of GSR challenges must be fine-tuned, including the exponential decrease of sample residues during the first hours after firing, as well as harmonization between laboratories and standardization for sample collection.Item Nanopartículas de plata sintetizadas por hongos como conservantes en cosméticos: Una Revisión de literatura(Universidad Santiago de Cali, 2026-06-02) Zuluaga Nitola, Katerin Yulieth; Ciro Monsalve, Yhors Alexander (Director)Se abordó la problemática de la conservación microbiológica en productos cosméticos, considerando los riesgos asociados al uso de conservantes sintéticos, tales como sensibilización e irritación cutánea. El objetivo del estudio fue analizar el potencial de las nanopartículas de plata (AgNP) biosintetizadas mediante hongos como conservantes cosméticos, a partir de la evaluación de su eficacia antimicrobiana, estabilidad en formulaciones, seguridad y viabilidad tecnológica. Para ello, se desarrolló una revisión de la literatura publicada entre 2021 y 2026. El análisis se estructuró en cuatro ejes temáticos: síntesis fúngica y caracterización fisicoquímica de las AgNP; estabilidad y compatibilidad en formulaciones cosméticas en comparación con conservantes tradicionales; evaluación del perfil toxicológico mediante estudios in vitro e in vivo; y análisis de ventajas, limitaciones, retos regulatorios y consideraciones ambientales. Los resultados indicaron que diversas especies fúngicas produjeron AgNP mediante mecanismos intra y extracelulares, con tamaños predominantes entre 10 y 200 nm, morfología mayoritariamente esférica y recubrimiento proteico que facilitó la estabilización de las partículas. Las AgNP exhibieron un amplio espectro antibacteriano y antifúngico, funcionando como conservantes eficaces a bajas concentraciones, sin afectar la estabilidad de las formulaciones ni la compatibilidad con otros activos cosméticos. La toxicidad observada dependió del tamaño, la dosis y el recubrimiento, con limitada penetración cutánea y reducción de citotoxicidad mediante encapsulación o funcionalización. No obstante, persistieron incertidumbres relacionadas con la liberación de Ag⁺, la exposición crónica y los posibles impactos ambientales, así como vacíos regulatorios. Se concluyó que las AgNP biosintetizadas por hongos representaron una alternativa prometedora y alineada con enfoques de síntesis verde; sin embargo, su aplicación requirió un control preciso de sus características fisicoquímicas, la validación de dosis seguras en condiciones reales de uso, la implementación de estrategias de reducción de toxicidad y el fortalecimiento de evaluaciones toxicológicas, ambientales y regulatorias que permitan una adopción responsable en la industria cosmética.Item Metformina en enfermedades metabólicas, análisis de adherencia terapéutica: Una revisión sistemática(Universidad santiago de cali, 2026-06-02) Zapata Osorio, Juan Carlos; Fernández Daza, Fabian Felipe (Director)Metformin has become established as the first-line treatment for type 2 diabetes mellitus and other metabolic diseases due to its efficacy, safety, and low cost. However, its long-term use poses clinical challenges related to adverse effects, therapeutic adherence, and effectiveness across different population contexts. This systematic review included 40 studies published between 2015 and 2025 from international databases, evaluating clinical trials, cohort studies, and observational research. The results show that metformin achieves consistent reductions in glycated hemoglobin (0.5–1.5%), fasting glucose, and insulin resistance, in addition to favorable effects on body weight and cardiovascular profile in at-risk populations. The most common adverse effects were gastrointestinal, generally mild and transient, while serious events such as lactic acidosis were reported in patients with advanced renal impairment. Therapeutic adherence was influenced by clinical, economic, cultural, and healthcare access factors, highlighting the importance of medical follow-up and appropriate dose titration. In conclusion, metformin maintains a favorable benefit–risk balance, consolidating its role as an essential drug in the comprehensive management of metabolic diseases and in the prevention of associated complications, although strategies to improve long-term tolerability and adherence are still needed.Item Desarrollo de nanopartículas de quitosano como vehículo para ampicilina en el tratamiento de infecciones bacterianas por Staphylococcus aureus(Universidad Santiago de Cali, 2024) Urbano Durango, Luis Carlos; Valencia Ojeda, Sharon Jiney; Ciro Monsalve, Yhors Alexander (Director); Oñate Garzón, José Fernando (Director)This study developed chitosan nanoparticles loaded with ampicillin to enhance their efficacy against Staphylococcus aureus. Nanoparticles were synthesized from chitosan with a degree of acetylation of 10% by ionic gelation with phytic acid and high-intensity ultrasound (30%, 35% and 40%). The nanoparticles were characterized by measurements of particle size, polydispersity index, zeta potential and their antimicrobial effectiveness was evaluated by the broth microdilution method. Sizes between 330.3 ± 3.1 nm and 389.7 ± 6.3 nm were obtained, with zeta potential of +39.3 ± 3.3 mV to +48.7 ± 0.9 mV, depending on the intensity of the applied ultrasound. The in-vitro antimicrobial activity showed that the minimum inhibitory concentration (MIC) of free ampicillin was 1 µg/mL, while, when included in nanoparticles, the MIC decreased to 0.5 µg/mL (30% and 35% ultrasound) and 0.25 µg/mL (40%). These results suggest that chitosan nanoparticles improve the antibacterial action of ampicillin and represent a promising alternative for more effective and sustainable antimicrobial treatmentsItem Aplicaciones de la espectroscopia Raman en la identificacion destructiva de sangre en escenas del crimen: Una revisión sistemática(Universidad Santiago de Cali, 2025) Lopez Ortega, Ronald Daniel; Ocampo Chaguendo, Denis Mauricio (Asesor)Raman spectroscopy has emerged as a promising tool in the nondestructive identification of blood at crime scenes, overcoming the limitations of traditional methods such as luminol or Kastle-Meyer. This systematic review analyzed 48 studies published between 2014 and 2025, evaluating the applicability of Raman versus conventional techniques. It was identified that Raman allows specific molecular analysis of hemoglobin, even in aged or contaminated samples, with high precision and without altering the evidence. However, its implementation faces challenges such as fluorescence interference, the need for robust databases and the cost of portable equipment. Comparison with traditional methods showed that, although the latter are more accessible and faster, they are less specific and tend to degrade samples. The integration of Raman with artificial intelligence and portable technologies represents the future in forensic blood detection, reinforcing the chain of custody and the reliability of findings in the judicial environment.Item Validación de metodología analítica para análisis de disolución de Loratadina 10mg tableta por espectrofotometría ultravioleta(2026-06-02) Lora Muñoz, Nicole Johanna; Ciro Monsalve, Yhors Alexander (Director)This research project aimed at the development and validation of an analytical methodology for the dissolution analysis of Loratadine 10 mg tablets, employing ultraviolet spectrophotometry as the instrumental technique. The validation process included the assessment of parameters such as system suitability, system and method linearity, accuracy, precision (repeatability and intermediate precision), analyte stability in solution, and method specificity. The results obtained demonstrated that the validated method meets the established acceptance criteria, ensuring reliability of the analytical results. These findings confirm that the proposed methodology is suitable for dissolution analysis of Loratadine 10 mg tablets by ultraviolet spectrophotometry, supporting its application in routine laboratory testing.Item Efectos hepatotóxicos que afectan la ALT y AST en el tratamiento de la tuberculosis pulmonar en medicamentos de primera línea y sus principales factores de riesgo(Universidad Santiago de Cali, 2026-05-25) Marin Henao, Luisa Fernanda; Echeverry Martínez, John Jairo (Director)Drug-induced hepatotoxicity is the most significant adverse reaction in first-line treatment for tuberculosis and represents a key obstacle to patients continuing treatment and achieving positive clinical outcomes. In this regard, the objective of this study was to conduct a comprehensive review of the literature on the hepatotoxic effects of isoniazid, rifampicin, pyrazinamide, and ethambutol, focusing on how they differentially affect biochemical markers and the role of associated risk factors. To this end, a descriptive review approach was used, systematically searching for and selecting clinical studies and research articles published in the last seven years in high-impact databases. The results of the review confirmed the toxicity hierarchy, identifying pyrazinamide and isoniazid as the main culprits in a pattern of mainly hepatocellular damage, evidenced by significant increases in ALT and AST transaminases. In addition, evidence was reinforced that factors such as advanced age, female gender, alcohol consumption, low body mass index, and HIV coinfection measurably increase the risk of liver damage. It was concluded that stratifying patient risk before starting therapy is essential as a clinical strategy for adequate biochemical monitoring. Finally, the limitation of current diagnostic markers was highlighted, suggesting the need to validate emerging biomarkers that allow for earlier and more proactive detection of subclinical liver injury.Item Potencial antioxidante de Matricaria Chamomilla L. en cosmética capilar orgánica: revisión sistemática(Universidad Santiago de Cali, 2026-05-12) Zemanate López, Angie Natalia; Romo Valdés, Pablo Emilio (Director)This paper conducted a systematic review of the antioxidant potential of Matricaria chamomilla L. (chamomile) in the field of organic hair cosmetics. The research was based on the growing demand for natural products in the cosmetics industry and the need to scientifically validate the benefits attributed to plant extracts. The main objective was to analyze the available evidence on the antioxidant mechanisms of chamomile, its efficacy in protecting hair and scalp from oxidative stress, and its applications in hair formulations. The methodology was developed using a qualitative and documentary approach, following the PRISMA guidelines for the search and selection of articles published between 2020 and 2025 in indexed databases such as PubMed, Scopus, and ScienceDirect. The results showed that chamomiles have a complex phytochemical profile, rich in flavonoids (apigenin, quercetin, luteolin), phenolic acids, and terpenoids (α-bisabolol, chamazulene), capable of neutralizing free radicals, modulating endogenous antioxidant enzymes, and reducing lipid peroxidation. Its protective effect on hair fibers, the scalp barrier function, and the prevention of UV radiation-induced photoaging were evident. Furthermore, clinical and preclinical studies support their safety and tolerability in topical formulations, provided standardized extracts are used.Item Validación del proceso de manufactura de una línea de polvos no efervescente(Universidad Santiago de Cali, 2026-05-25) Valencia Carreño, David; Castillo Ayala, Jorge Enrique (Director)The study for this project addresses the need to establish reproducibility when validating the manufacturing process of a non-effervescent powder product, in accordance with the World Health Organization's (WHO) Good Manufacturing Practices (GMP) guidelines. The overall objective of this research was to validate the process's ability to consistently produce a product that meets predefined quality attributes, as required by the regulatory framework. An integral qualification and quantification methodology was used, based on verifying the documentary and infrastructure prerequisites. Subsequently, the manufacturing of the process stages (Dispensing, intermediate product mixing, packaging and conditioning, and final product release) was executed and documented, with strict monitoring of process parameters and a statistical analysis of the data. The results showed satisfactory yields in the bulk product, and content uniformity was confirmed through in-process weight control during product packaging. Therefore, the manufacturing process is established as validated, proving to be robust and reproducible for commercial-scale production, ensuring the quality required by the regulations.Item Uso del cannabis medicinal como alternativa en el manejo de trastornos psiquiátricos con resistencia farmacológica(Universidad Santiago de Cali, 2025) Rios Delgadillo, Santiago; Oñate Garzón, José Fernando (Asesor)In recent years, the administration of medicinal cannabis has appeared as a therapeutic alternative to psychiatric disorders that do not respond to traditional pharmacological treatments. This systematic review will address the use of cannabidiol (CBD), which is one of the active ingredients of the Cannabis sativa plant, used in disorders that affect mental health such as: anxiety, depression, bipolar disorder or autism spectrum disorders (ASD). To this end, a search was carried out into scientific literature published between 2017 and 2024 regarding the therapeutic effects of CBD in patients with the aforementioned disorders that do not respond to standard pharmacological treatments. Scientific literature that showed significant improvements in the reduction of psychiatric symptoms or in the treatment of situations such as craving, which is an intense and often uncontrollable desire to consume a pleasurable substance, commonly associated with addictions, was included. This research reveals multiple studies that affirm that the use of medicinal Cannabis is essential as a long-term treatment for the presence of disorders associated with depression and anxiety.Item Formulación y caracterización preliminar de gomas comestibles con cannabidiol (CBD) como apoyo en el manejo del síndrome premenstrual en mujeres jóvenes(Universidad Santiago de Cali, 2026-05-21) Collo Pencue, Girlessa; Restrepo Zapata, Jorge Humberto (Director)Premenstrual syndrome (PMS) affects a large proportion of women of reproductive age, causing physical and emotional symptoms that negatively impact their quality of life and daily performance. Although pharmacological treatments are available, they may produce undesirable side effects or low patient adherence. In recent years, cannabidiol (CBD), a non-psychoactive compound derived from Cannabis sativa, has gained attention due to its anxiolytic, anti-inflammatory, and analgesic properties. Among emerging pharmaceutical forms, CBD-infused edible gummies stand out for their easy administration, sensory acceptability, and potential therapeutic use in young women. This monograph presents a review of national and international scientific literature analyzing the feasibility of using CBD gummies as a complementary alternative for PMS management. Pharmacological aspects of CBD, its applicability in relation to PMS symptoms, and the design of edible formulations are discussed. The results indicate that CBD may help reduce symptoms such as pain, anxiety, irritability, and inflammation associated with PMS; however, specific clinical evidence regarding CBD gummies is still limited. This study aims to contribute to the academic and scientific discussion on natural and functional strategies in women’s healthcare.