Search Results (44)

People living with HIV (PLHIV) are at an increased risk of progressing from Mycobacterium tuberculosis (TB) infection to TB disease. Tuberculosis preventive treatment (TPT) is recommended for PLHIV; however, its uptake remains suboptimal. In Zimbabwe, three months of weekly rifapentine and isoniazid (3HP) and six months of daily isoniazid (6H) are the most commonly prescribed TPT regimens. We explored barriers to TPT uptake among PLHIV from the perspective of healthcare workers (HCWs) in Zimbabwe. Facility nurses who had been implementing TPT for at least six months were invited to participate in in-depth interviews and/or focus group discussions conducted in March 2023. Audio recordings were transcribed into English, coded using NVivo 12 (QSR International), and analyzed thematically. Eleven HCWs participated in in-depth interviews and 15 in focus group discussions. Barriers were categorized as person- and health system-related. Person-related barriers included misconceptions about TPT, fear of adverse events, and pill burden. Health system barriers included stock-outs of TPT medications, limited HCW knowledge and skills to promote TPT, limited expertise in initiating TPT among children under five years of age, and limited access to chest radiography. Barriers to TPT uptake and completion remain in Zimbabwe and contribute to missed opportunities for TB prevention among PLHIV. TPT implementation could be strengthened through an uninterrupted supply of TPT medications, continuous training and mentorship of HCWs, and community engagement to improve awareness of the benefits and risks of TPT. Full article

Background and Objectives: Hyperphosphatemia is a key component of chronic kidney disease-mineral and bone disorder and is associated with higher rates of cardiovascular events and mortality in patients undergoing dialysis. Phosphate binders are essential for phosphorus reduction, and their evaluation relies on several factors, such as chemical composition, binding capacity, and safety profile. Unfortunately, long-term management is hindered by high pill burden and poor adherence. Magnesium phosphate binders have proven effectiveness in reducing phosphate levels. Nevertheless, despite their efficacy, they are not widely used in clinical settings because of concerns related to their use. This study assessed the efficacy of low-dose magnesium carbonate as a phosphate binder in patients undergoing chronic dialysis, focusing on its biochemical control, tolerability, and cost-effectiveness. Materials and Methods: A prospective observational study was conducted on 54 hemodialysis patients with end-stage renal disease at a single dialysis center. Patients were taking either 250 mg magnesium carbonate or 2400 mg sevelamer carbonate for 3 months. Results: Both groups showed decreased phosphorus levels, with a 14.2% significant reduction in the magnesium carbonate group (p < 0.001) and a 5.1% reduction in the sevelamer carbonate group. At the end of the study, no significant differences were observed between the groups (p = 0.682). In the magnesium carbonate group at month 3, compared to baseline, no significant differences were detected in other laboratory parameters reflecting calcium–phosphorus metabolism (Ca—p = 0.681, PTH—p = 0.126). Simultaneously, good compliance without clinically relevant gastrointestinal side effects was observed, including the absence of clinically significant hypermagnesemia. Conclusions: The phosphorus-lowering potential of low-dose magnesium carbonate is non-inferior to that of low-dose sevelamer carbonate. However, its favorable safety profile, low incidence of adverse effects, and cost-effectiveness make it a promising option in clinical practice, further highlighting the need for better recognition by physicians. Full article

Background/Objectives: Adult degenerative lumbar deformity is a heterogeneous condition in which outcome depends on radiographic correction, patient-related risk factors, and surgical burden. This study evaluated spinopelvic realignment, clinical outcomes, complications, and predictors of unfavorable postoperative course after surgical treatment of adult degenerative lumbar deformity. Methods: This three-center retrospective cohort study included adult patients who underwent posterior decompression and instrumented fusion, with or without interbody fusion, for adult degenerative lumbar deformity between January 2021 and December 2024. Of 136 screened patients, 113 completed final follow-up and were included in the analysis. The mean follow-up duration was 31.0 ± 12.9 months. Radiographic parameters were assessed preoperatively, immediately postoperatively, and at final follow-up. Patient-reported outcome measures were analyzed using available paired data. Unfavorable postoperative course was defined as persistent or worsened pain with functional limitation, symptomatic mechanical complication, deep infection requiring surgical treatment, or revision/reoperation. Results: Surgery produced significant immediate improvement in coronal and sagittal alignment. Cobb angle improved from 29.8 ± 13.1° to 13.7 ± 6.7°, lumbar lordosis increased from 28.8 ± 15.5° to 40.3 ± 16.0°, PI–LL mismatch decreased from 21.7 ± 10.0° to 10.1 ± 11.5°, and SVA decreased from 58.8 ± 31.4 mm to 32.5 ± 36.0 mm. Partial loss of correction was observed at final follow-up, although alignment generally remained improved compared with baseline. ODI improved from 57.8 ± 12.6 to 34.7 ± 8.7 in patients with available paired data. Any postoperative complication occurred in 42.5% (n = 48) of patients, revision/reoperation in 23.9% (n = 27), and unfavorable postoperative course in 35.4% (n = 40). In multivariable analysis, osteoporosis, greater fusion length, and residual immediate postoperative PI–LL mismatch were independently associated with unfavorable postoperative course. Conclusions: In this three-center retrospective cohort, surgery for adult degenerative lumbar deformity was associated with significant radiographic correction and meaningful clinical improvement in patients with available paired outcome data. However, the substantial complication and revision/reoperation burden highlights the morbidity of adult degenerative lumbar deformity surgery. Osteoporosis, fusion length, and residual immediate postoperative PI–LL mismatch may help identify patients at higher risk for unfavorable postoperative course. Full article

Background/Objectives: Pain is a common symptom in patients undergoing hemodialysis (HD) and may influence their quality of life. Pain self-efficacy may play an important role in self-management and adherence behaviors. This study aimed to examine the association between pain self-efficacy and adherence to the HD regimen in patients undergoing HD. Methods: In this descriptive and cross-sectional study, 199 patients undergoing HD from a single private hospital (convenience sample) in Athens, Greece, completed the Greek-Simplified Adherence Questionnaire-HD (GR-SMAQ-HD) to assess adherence and the Pain Self-efficacy Questionnaire (PSEQ) to assess pain self-efficacy. Sociodemographic and clinical data were also recorded. Bivariate analyses and multiple linear regression were performed to identify factors associated with adherence. Statistical significance was set at p < 0.05. Results: Patients demonstrated moderate levels of pain self-efficacy (mean PSEQ = 33.96 ± 9.74) and moderate adherence to the HD regimen (mean GR-SMAQ-HD = 4.78 ± 2.54). No significant correlation was found between pain self-efficacy and adherence in bivariate analysis (rho = 0.125, p = 0.221). However, in multivariate analysis, pain self-efficacy was a significant independent predictor of adherence (β = 0.056, p = 0.032). Longer duration of End-Stage Renal Disease (ESRD) (β = −0.158, p < 0.001), higher pill burden (rho = −0.237, p = 0.030) were associated with lower adherence. Marital status was also a significant predictor of adherence (β = 1.631, p = 0.016). The model explained 24% of the variance in adherence (Adjusted R² = 0.24). Conclusions: Pain self-efficacy may indirectly affect adherence to the HD regimen, although its direct effect is modest. Adherence appears to be negatively influenced by pill burden and ESRD duration, while social support may play an important role. Full article

Background: Pediatric tuberculosis (TB) remains a major global health concern, accounting for a substantial proportion of TB-related morbidity and mortality worldwide. Treatment in children is particularly challenging due to age-specific pharmacokinetics, difficulties in drug administration, poor palatability, and reliance on caregivers for adherence. Objectives: This narrative review aims to evaluate the advantages and limitations of fixed-dose combinations (FDCs) in the treatment of pediatric TB, with a focus on adherence, pharmacological considerations, clinical outcomes, and implementation challenges. Methods: A narrative review of the literature was conducted, including clinical studies, pharmacokinetic analyses, programmatic data, and international guidelines related to the use of FDCs in pediatric TB management. Results: Evidence indicates that pediatric FDCs significantly improve treatment adherence by reducing pill burden and simplifying dosing regimens. They also decrease the risk of medication errors and inadvertent monotherapy, thereby contributing to the prevention of drug resistance. The availability of dispersible, child-friendly formulations has enhanced acceptability and ease of administration. However, limitations persist, including reduced flexibility in dose individualization, challenges in identifying the causative agent in adverse drug reactions, and variable access across settings. Pharmacokinetic concerns, particularly regarding rifampicin exposure, have been addressed in newer WHO-recommended formulations. Conclusions: FDCs represent a critical advancement in pediatric TB management and are strongly supported by international guidelines. Further research is needed to optimize formulations, ensure equitable access, and evaluate long-term clinical outcomes in diverse pediatric populations. Full article

Objective: To explore healthcare professionals’ beliefs and concerns about doxyPEP by systematically reviewing the literature. Method: A systematic review of three bibliographical databases (CINAHL, EMBASE and MEDLINE) and MedRxiv in August 2024, updated in February 2026 explored healthcare professionals’ beliefs and concerns about doxyPEP. Three researchers independently reviewed full-text manuscripts for eligibility and narratively synthesized data. We used the Joanna Briggs Institute toolkit to assess risk of bias. This review was registered on PROSPERO (ID:CRD42024570646). Results: Eight manuscripts were included in the final review: five cross-sectional studies, two qualitative studies, and one mixed method study from the USA (n = 5), Australia (n = 1), Kenya (n = 1), and the UK (n = 1) published between 2020–2025 and including 1840 healthcare professionals. Healthcare professionals recognised the high burden of bacterial STIs and believed that doxyPEP should be made available to MSM. There was a strong willingness to provide doxyPEP to MSM with the support of national guidelines. Healthcare professionals suggest that implementing doxyPEP would be feasible with educational support, but were concerned about antimicrobial resistance, drug–drug interactions, pill burden, cost, implementation logistics and the effect on clinical service demands. They acknowledged the lack of research and access to doxyPEP for other groups, specifically trans people and cis-gendered women. They also highlighted the need for community involvement in the implementation of doxyPEP. Conclusions: This review highlights that healthcare professionals were willing and ready to provide doxyPEP; however, they have concerns including antimicrobial resistance, the effect on service capacity, and the lack of research on cis-gendered women and trans people. Patients and health professionals need to be involved in the implementation of doxyPEP. Full article

Background/Objectives: Ulcerative colitis (UC), a chronic inflammatory bowel disease, affects approximately 5 million individuals worldwide, exerting a considerable influence on global health and economic systems. Among the challenges in UC management, treatment non-adherence stands out as a critical issue, often compromising therapeutic efficacy. One strategy to address this challenge is by reducing pill burden, which may improve patient compliance and optimize treatment outcomes. Methods: This randomized, two-sequence, four-period, crossover replicate study evaluated the pharmacokinetic profiles, bioequivalence, and safety of a newly developed 1500 mg mesalazine gastro-resistant tablet compared to three of the reference 500 mg Claversal^® gastro-resistant tablets (total dose 1500 mg) in 80 healthy participants under fasted conditions. Results: Bioequivalence between mesalazine formulations was observed in both the rate and extent of systemic bioavailability. The geometric mean ratios and their 90% CI were 102.51% (95.85–109.63) for AUC_0–∞, 103.36% (96.40–110.83) for AUC_0–t, 84.49% (78.24–91.24) for AUC_8–48h, and 114.24% (100.15–130.32) for C_max. All within the accepted bioequivalence ranges, confirming comparable pharmacokinetic performance. Secondary pharmacokinetic parameters such as t_max, t_1/2, K_e, Cl, and MRT were also consistent across both formulations. The incidence of adverse events was comparable between the two mesalazine formulations, with only flatulence and mild self-limited rash considered possibly related to test treatment. Conclusions: Overall, the 1500 mg formulation demonstrated a pharmacokinetic profile and tolerability comparable to the reference formulation, offering a higher-strength option to reduce daily pill burden. This strategy is of clinical relevance, particularly for improving treatment adherence among UC patients who need to take multiple pills daily to achieve their required dosage. While adherence is influenced by various factors, reducing pill burden may facilitate compliance and optimize therapeutic efficacy. Full article

Tuberculosis preventive treatment (TPT) is a mainstay for reducing the tuberculosis (TB) burden among people living with human immunodeficiency virus (PLHIV). Context-specific challenges hinder TPT uptake and completion among PLHIV. During 2022–2024, a mixed-methods design was used to evaluate the TPT cascade and explore its facilitators and barriers among PLHIV availing care from 12 PEPFAR-supported health facilities in Uganda. The quantitative component included analysis of routine programmatic data, and the qualitative component included focus group discussions and in-depth interviews with healthcare workers and PLHIV. A total of 1349 PLHIV were enrolled in the evaluation. Among PLHIV newly initiated on ART (≤3 months), 74% started TPT, and 98% of them completed it. In PLHIV already on ART, 87% had initiated TPT (76% before and 11% during this evaluation), with a treatment completion rate of 98%. The facilitators for TPT implementation included access to shorter TPT regimens, integration of services, and adherence counseling. Barriers included knowledge gaps, pill burden, TPT drug stock-outs, and documentation inconsistencies. The TPT completion rate was higher than the national target (90%), but the TPT initiation remains low. Improved access to shorter regimens, adherence counseling, better documentation, and service integration can sustain the completion rate and improve the initiation rate in Uganda and possibly elsewhere. Full article

Lifestyle-related diseases, such as overweight/obesity, diabetes mellitus type 2 (T2DM), cardiovascular disease, or osteoarthritis, are a major health burden in Western societies. Due to common risk factors, most patients suffer from multimorbidity, i.e., have been diagnosed with more than one of these diseases. Physical activity (PA) is known to have a positive effect on all of these diseases; however, little is known about the effects of PA on patients with multimorbidity. In particular, so far, no reliable biomarkers have been found to predict and monitor the effects of PA-based lifestyle intervention programs on these subjects. Employing a metabolomics approach with dried blood spots, we analyzed the concentrations of different metabolites in subjects with multimorbidity over the course of the lifestyle intervention program MultiPill-Exercise. We found increased concentrations of all tested amino acids (AAs), total carnitine (Cx), and short- (C2-C6) and long- (>C12) chain acylcarnitines (ACs) after 12 weeks (t1) and/or 24 weeks (t2) of intervention. When correlating baseline (t0) metabolite concentrations with changes in physiological and clinical parameters, we observed associations of various metabolite concentrations with changes in metabolic and cardiovascular parameters. When analyzing metabolite acute reactions in response to exhaustive exercise (ergometer test), however, few overall changes were observed. Nevertheless, a significant negative correlation was found between the mobilization of medium-chain acylcarnitines (MC-ACs) at t2 and changes in peak power output (PPO) between t0 and t2. Taken together, these data suggest that specific AAs and ACs might be candidate biomarkers to predict and monitor the effects of PA-based lifestyle intervention programs in subjects with multimorbidity, a hypothesis that should be further tested in larger cohorts. Full article

Polypharmacy is typically seen as an unavoidable consequence of multimorbidity and aging, with clinicians addressing complex medication lists unsystematically. In this perspective, we argue that polypharmacy should be managed as a chronic condition. Like diabetes or hypertension, for example, the medication burden shows persistence, progression in its absence despite active management, predictable complications (such as falls, delirium, renal injury, functional decline), and a need for structured surveillance. We introduce a pragmatic diagnostic framework that moves beyond pill counts to modality-agnostic, regimen-level risk across prescribed and non-prescribed medicines. Diagnosis rests on prolonged exposure, composite burden indices (e.g., anticholinergic/sedative load), medication-related complications or prescribing cascades, and the need for a planned review. As biologics, gene therapies and long-acting formulations can lower tablet numbers while increasing monitoring, administration, and interaction complexity. We treat polypharmacy as cumulative pharmacodynamic and operational burden. We advocate stage matched care with unique, functional aims—decreasing the harmful burden instead of mass deprescribing—and position a structured medication review as the standard for polypharmacy with support from pharmacists, shared decision making, and safety netted taper plans. The framework fosters patient-centred care, embedding continuity and equity, and outlines a concise outcome set that integrates pharmacometric measures with patient-reported function and treatment burden. At the systems level, the framework enables registries, recall systems, decision support, and audit/feedback mechanisms to shift from sporadic medication list clean-up to a structured, measurable long-term program. Redefining polypharmacy in this way aligns clinical practice, education, and policy with real-world evidence, fostering a cohesive pathway to safer, streamlined, and more patient-centred care in community settings. Full article

Background: Hypertension is a major global public health problem whose prevalence is increasing across the world. In consideration of this, there is insufficient understanding of the barriers that hinder the taking of anti-hypertensive medication among patients. In this regard, the aim of this study was to analyze the possible barriers undermining adherence to anti-hypertensive medication among patients in private healthcare in Edenvale, South Africa. Methodology: This study used an exploratory cross-sectional research design within which quantitative data were collected through an online survey on a sample of randomly selected hypertensive patients attending private healthcare facilities in Edenvale. Participation in this study was voluntary, and informed consent was sought from each participant. Anonymity was assured during data collection through the de-identification of respondents and any data about them. The collected data were subjected to descriptive statistical analysis. Results: One hundred and twenty-two patients participated in this study. From this, 34.4% of participants revealed that lack of awareness was a barrier to a very small extent. Forgetfulness was a possible barrier to adherence to a large extent amongst 16.4% of participants, and 26.2% of the respondents had, to a large extent, doubts about their hypertension diagnosis. However, 42.6% revealed that side effects and difficulty taking medication whilst away from home (47.5%) were a barrier to a small extent. The fear of side effects (19.7%), interference of alcohol or drug use (29.5%) were challenges to a moderate extent. Conclusions: The findings of this study support that hypertensive patients in private healthcare encounter financial constraints, occasionally forget to take their medication, doubt their hypertension diagnosis, and lack awareness about the benefits of taking anti-hypertensive medication. This may be compounded by patients finding the anti-hypertensive medication regimen too complicated, feeling overburdened by having to take too many pills every day, the complexity of the medication regimens, perceived incorrect diagnosis, and lack of social support from family and friends. Understanding the extent of the barriers encountered by patients in taking anti-hypertension medication may help address adherence challenges, which may help improve health outcomes and lessen the burden on health systems in pursuing Sustainable Development Goal 3 and universal health coverage. Full article

Pregnant and postpartum people (PPPs) face heightened risk for HIV acquisition, yet depression and trauma-related symptoms can undermine adherence to pre-exposure prophylaxis (PrEP). To inform the development of a brief mental health-focused adherence intervention, we explored the impacts of depression and posttraumatic stress disorder (PTSD) symptoms on PrEP use among PPPs in Cape Town, South Africa. Twenty-eight PPPs with elevated symptoms of depression and/or PTSD and recent PrEP adherence challenges completed qualitative interviews. Six antenatal providers were also interviewed. Thematic analysis revealed three key findings with subthemes that deepen exploration of each theme: (1) depression and PTSD symptoms contributed to missed PrEP doses or late pickups by increasing doubt about PrEP efficacy, amplifying pill burden, intensifying avoidance and withdrawal (e.g., hypersomnia and disengagement from providers), and disrupting memory through rumination and emotional overload; (2) most PPPs preferred support from professional counselors, while a minority preferred informal support; and (3) intervention design considerations included aligning patient and provider goals, selecting between individual or group formats, and addressing integration barriers such as staffing and space constraints. Providers affirmed the need for embedded mental health support. Intervention strategies that increase PrEP knowledge and motivation while targeting emotional withdrawal, fatigue, and cognitive overload may improve adherence and reduce HIV risk in this population. Full article

Background/Objectives: Using healthcare vouchers mitigates the financial burdens of low-income individuals, therefore enhancing mothers’ satisfaction and encouraging service utilization. In Yemen, reducing financial barriers results in marked improvement in reproductive health services utilization for mothers and their newborns. Such financial strain can be addressed through reproductive health vouchers, which reduce out-of-pocket expenses of family planning, pregnancy, birth, postnatal care and neonatal care. This study compares the Safe Motherhood and Family Planning Voucher Program in the Lahj governorate to the non-voucher program in the Abyan governorate in terms of enhancement of reproductive healthcare accessibility and use. Methods: This facility-based, quantitative, comparative, cross-sectional study was conducted in the Lahj governorate, which supports the Safe Motherhood and Family Planning Voucher Program, and the Abyan governorate, which does not. Results: The voucher-supported program has greatly improved mothers’ satisfaction, access, and use of all reproductive health services by covering transportation, covering lodging during hospitalization, and providing free reproductive treatments. Compared to Abyan mothers, Lahj governorate mothers more frequently used rental vehicles (paid for by the voucher program) and free reproductive health services (p-value < 0.001). Lahj governorate mothers (who used the vouchers) used family planning, prenatal care, facility-based delivery, home delivery by competent birth staff, cesarean section, postnatal care, and neonatal care more frequently than Abyan governorate mothers. A health institution which supported the Safe Motherhood and Family Planning Voucher Program (SMHFPVP) provided prenatal care (98.5%), competent birth services (99.0%), and modern contraceptive use (92.3%)—oral contraceptive pills, implants, injectables, contraceptive patches, vaginal rings, and intrauterine devices—for mothers who were interviewed and attended the targeted HFs in the Lahj governorate, compared with (77.6%), (80.3%), and (67.8%), respectively, for mothers in Abyan governorate who were not supported by the SMHFPVP. This study demonstrates substantially higher satisfaction levels among voucher-using mothers in the Lahj governorate compared to those in the Abyan governorate, across all satisfaction domains and overall satisfaction scores. Conclusions: This study found that women without access to maternal health vouchers experienced worse prenatal, natal, and postnatal care and were less satisfied with healthcare services compared with women who used vouchers. Full article

Phosphorus is one of the most abundant minerals in the body and plays a critical role in numerous cellular and metabolic processes. Most of the phosphate is deposited in bones, 14% is present in soft tissues as various organic phosphates, and only 1% is found in extracellular space, mainly as inorganic phosphate. The plasma inorganic phosphate concentration is closely maintained between 2.5 and 4.5 mg/dL by intertwined interactions between fibroblast growth factor 23 (FGF-23), parathyroid hormone (PTH), and vitamin D, which tightly regulate the phosphate trafficking across the gastrointestinal tract, kidneys, and bones. Disruption of the strict hemostatic control of phosphate balance can lead to altered cellular and organ functions that are associated with high morbidity and mortality. In the past three decades, there has been a steady increase in the prevalence of kidney failure (KF) among populations. Individuals with KF have unacceptably high mortality, and well over half of deaths are related to cardiovascular disease. Abnormal phosphate metabolism is one of the major factors that is independently associated with vascular calcification and cardiovascular mortality in KF. In early stages of CKD, adaptive processes involving FGF-23, PTH, and vitamin D occur in response to dietary phosphate load to maintain plasma phosphate level in the normal range. However, as the CKD progresses, these adaptive events are unable to overcome phosphate retention from continued dietary phosphate intake and overt hyperphosphatemia ensues. As these hormonal imbalances and the associated adverse consequences are driven by the underlying hyperphosphatemic state in KF, it appears logical to strictly control serum phosphate. Conventional dialysis is inadequate in removing phosphate and most patients require dietary restrictions and pharmacologic interventions to manage hyperphosphatemia. However, diet control comes with many challenges with adherence and may place patients at risk for inadequate protein intake and malnutrition. Phosphate binders help to reduce phosphate levels but come with a sizable pill burden and high financial costs and are associated with poor adherence and psychosocial issues. Additionally, long-term use of binders may increase the risk of calcium, lanthanum, or iron overload or promote gastrointestinal side effects that exacerbate malnutrition and affect quality of life. Given the aforesaid challenges with phosphorus binders, novel therapies targeting small intestinal phosphate absorption pathways have been investigated. Recently, tenapanor, an agent that blocks paracellular absorption of phosphate via inhibition of enteric sodium–hydrogen exchanger-3 (NHE3) was approved for the treatment of hyperphosphatemia in KF. While various clinical tools are now available to manage hyperphosphatemia, there is a lack of convincing clinical data to demonstrate improvement in outcomes in KF with the lowering of phosphorus level. Conceivably, deleterious effects associated with hyperphosphatemia could be attributable to disruptions in phosphorus-sensing mechanisms and hormonal imbalance thereof. Further exploration of mechanisms that precisely control phosphorus sensing and regulation may facilitate development of strategies to diminish the deleterious effects of phosphorus load and improve overall outcomes in KF. Full article

Background/Objectives: Fixed-dose combinations (FDCs) offer significant advantages for patients and healthcare systems by improving adherence and reducing pill burden. However, developing multi-drug formulations remains challenging due to complexities in drug compatibility, stability, and dissolution behavior. The COVID-19 pandemic has necessitated innovative therapeutic approaches. This study aims to develop and evaluate an FDC containing FR (an antiviral drug) and RT (a PDE4 inhibitor) for potential COVID-19 treatment. Methods: The proposed dual-layer FDC was formulated to achieve immediate release of RT using Klucel EXF and controlled release of FR using a combination of Klucel HXF and Compritol ATO888. Critical quality attributes, including drug–excipient compatibility, solid-state properties, tablet uniformity, and dissolution kinetics, were assessed. RT and FR quantification methods were developed and validated per international guidelines. Compatibility studies were conducted by combining excipients in fixed ratios with APIs, followed by stability testing. Results: No degradation or adverse interactions were observed between APIs and excipients. RT exhibited rapid dissolution within 30 min, while FR release was effectively controlled through a gel-forming matrix and lipid barrier. Bulk powder and tablet physical parameters met pharmacopeial standards, and content uniformity between layers was maintained. The formulation demonstrated a stable dissolution profile for both drugs, ensuring consistent drug release. Conclusions: The novel FDC of RT and FR exhibits favorable physicochemical properties, a stable dissolution profile, and potential for improved treatment efficacy in COVID-19 patients. By optimizing drug release mechanisms and ensuring formulation stability, this FDC could serve as a pharmaco-economically viable alternative to existing therapies, enhancing patient compliance and treatment outcomes. Full article