Background: Leishmaniasis is a neglected tropical disease and its cutaneous form manifests as ulcers or nodules, generally in exposed parts of the body. This work aimed to develop ivermectin (IVM) ...
Aim: This study focused on evaluating the influence of geometric dimensions on the drug release kinetics of 3D-printed tablets.Materials & methods: An ink based on Gelucire 50/13 was prepared to print ivermectin-loaded tablets. The ink was characterized physicochemically and tablet dissolution tests were carried out.Results: The results confirmed the suitability of the ink for 3D printing at a temperature >46°C. Changes in the crystallinity of ivermectin were observed without chemical interactions with the polymer. 3D printed tablets with varied proportional sizes showed dual behavior in their release profiles, while tablets with only thickness reduction exhibited zero-order kinetics.Conclusion: These findings highlight the versatility of 3D printing to create systems with specific and customized release profiles.
Albendazole (ABZ) and benznidazole (BZL) are drugs with low solubility used in parasitic infections treatment. In this research, solid dispersion (SD) technology was used to enhance ABZ and BZL performance by increasing their dissolution rate and solubility. SDs were prepared by the fusion method, employing Poloxamer 407 (P407) as carrier to disperse 32 of BZL or 50% w/w of ABZ. Furthermore, physical mixtures (PM) of P407 and either ABZ or BZL were also prepared, and then SDs and PMs were characterized. Dissolution tests of SDs, PMs and commercial formulations (CF) of ABZ and BZL were carried out and dissolution profiles were analyzed with the lumped mathematical model, which allowed parameters of pharmaceutical relevance to be obtained. The results indicated that ABZ SD presented an initial dissolution rate (IDR) 21-fold and 11-fold faster than PM and CF, respectively, while the IDR of BZL SD was 2.5-fold and 4.5-fold faster than PM and CF, respectively. For BZL formulations, the time required to reach 80% dissolution of the drug (t80%) was 4 (SD), 46 (PM), and 239 min (CF), while the dissolution efficiency (DE) at 30 min was 85 (DS), 71 (MF) and 65% (FC). For ABZ formulations, t80% was 2 (SD), value not reached (PM) and 40 min (CF), while the DE at 30 min was 85 (SD), 36 (MF) and 65% (CF). The SDs developed notably increased the dissolution rate, in consonance with the values obtained from the pharmaceutical parameters, which could lead to faster absorption and, consequently, increase the bioavailability of these drugs.
Ciprofloxacin (Cipro) is a broad-spectrum antibiotic used against both Gram (+) and Gram (−) bacteria. Its biological half-life is very short (4–5 h) and its conventional administration forms present a limited absorption efficiency. For this reason, the aim of this work was to study other administration strategies based on topical films. Sodium alginate (SA), a naturally occurring polymer, and a recombinant elastin-like polymer (rELP) produced by advanced genetic engineering techniques were evaluated as potential carrier systems. The films were obtained by the casting technique, adding the Cipro by direct dispersion in the polymer solution using 16.6% w/w rELP or 1.5% w/w SA. The in vitro release assays were performed at 37 °C in physiological solution and with orbital shaking at 90 rpm. Cipro concentration was determined by ultraviolet (UV) spectrophotometry at 276 nm. The release profiles were analyzed and adjusted using the Lumped model developed and validated by our research group. Pharmaceutical interest parameters were calculated and compared for both polymer-Cipro systems: the time required to reach 80% of the drug dissolved (t80%), the dissolution efficiency (DE) and the mean dissolution time (MDT). The SA-Cipro platform released the 80% of the drug in 35 min, while this parameter was 209 min for the rELP-Cipro system. The MDT80% was 8.9 and 53 min for the SA-Cipro and rELP-Cipro, respectively, while the DE, evaluated at 200 min, was 66.6 and 58.8 for each platform, respectively. These parameter values demonstrate that the rELP films were able to modulate the drug release rate and for the SA ones, release can be considered immediate. Therefore, both systems are promising strategies for the topical application of Cipro.
Background/Objectives: In vitro dissolution tests are an essential tool in pharmaceutical development, allowing for the analysis of biopharmaceutical properties, understanding release mechanisms, and comparing formulations. The wide variety of mathematical models available for interpreting the profiles obtained creates ambiguity and difficulty in their selection and application. The objective of this work was to develop a decision tree algorithm that, based on the initial observation of the experimental profile, rationally guides the selection of the most appropriate mathematical model, considering their advantages and limitations. Methods: A review of classical and recent dissolution/release models was conducted, highlighting their constraints and parameters of pharmaceutical relevance. Based on this information, a decision tree was designed, integrating observational (curve shape, burst or lag time phenomena), statistical (R², AIC), and interpretability criteria. The algorithm was validated using topical and oral representative systems: hydrogels, polymeric films, modular systems (Dome Matrix), and 3D-printed pills. Results: The decision tree allowed reducing the number of candidate models and guiding the selection toward equations consistent with the observed phenomena. The usefulness of the Lumped–Gonzo model, capable of fitting complete profiles and providing physically meaningful parameters, was highlighted compared to classic models such as Weibull or Korsmeyer–Peppas. The methodology proved to be versatile and applicable to different release mechanisms. Conclusions: The proposed algorithm constitutes a flexible and practical tool that facilitates the rational selection of mathematical models. It does not replace the researcher's judgment, but rather complements it, promoting a more efficient use of mathematical modeling in the development of dosage forms.