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Bacterial vaginosis, a polymicrobial clinical syndrome characterized by a shift in healthy vaginal microbiota due to bacterial colonization, is characterized by high recurrence rates after conventional treatment with an antimicrobial agent. This has necessitated the need to develop a formulation that has the potential to ensure Lactobacilli viabili...
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... However, the recurrence rate remains high, and adverse effects such as dizziness, headache, vaginal itching, burning, and discharge are frequently observed with intravaginal metronidazole. Prolonged or repeated use of this antibiotic can also predispose individuals to secondary vaginal yeast infections (9,10). As an alternative, the use of intravaginal probiotics has gained attention for their ability to restore a healthy vaginal microbiota. ...
... Recent studies have highlighted the potential of intravaginal probiotics as an alternative therapy, offering restoration of normal vaginal flora without the adverse effects associated with antibiotics. Despite these promising findings, local data comparing the efficacy of these treatment options remains scarce, underscoring the importance of the present study (10)(11)(12). The study revealed a mean patient age of 27.2 ± 5.3 years, comparable to findings reported in other populations, which strengthens the generalizability of the results. ...
Background: Bacterial vaginosis (BV) is a prevalent vaginal infection caused by an imbalance of lactobacillus-dominated flora and overgrowth of anaerobic bacteria such as Gardnerella vaginalis and Mycoplasma hominis. Standard treatment with intravaginal metronidazole often faces limitations such as recurrence, adverse effects, and poor compliance. Probiotics have emerged as a potential alternative by restoring vaginal microbiota without significant side effects. This study aimed to compare the efficacy of intravaginal probiotics and metronidazole for treating bacterial vaginosis. Objective: To compare the frequency of successful treatment in patients with bacterial vaginosis treated with intravaginal metronidazole versus intravaginal probiotics. Methods: This randomized controlled study was conducted over six months at the Department of Obstetrics & Gynecology, Sandeman Provincial Hospital, Quetta. A total of 66 women aged 18-35 years with BV (Nugent score ≥7) were randomly allocated into two groups. The BV-P group received intravaginal probiotics, while the BV-M group received intravaginal metronidazole. Treatment success was defined as the resolution of fishy odor and a Nugent score <4 at 30 days post-treatment. Baseline characteristics, follow-up Nugent scores, and treatment outcomes were recorded and analyzed using SPSS version 20.0. Results: Participants had a mean age of 27.2 ± 5.3 years, with 37.9% aged 18-25 years and 62.1% aged 26-35 years. The mean disease duration was 12.8 ± 4.2 days. At baseline, both groups were comparable in age, disease duration, and Nugent scores (p > 0.05). At follow-up, the probiotics group demonstrated a significantly lower Nugent score (2.24 ± 1.50 vs. 3.79 ± 2.52, p = 0.004) and a higher success rate (90.9% vs. 60.6%, p = 0.004). Probiotics maintained superior outcomes across all subgroups. Conclusion: Intravaginal probiotics showed significantly better efficacy than metronidazole in treating bacterial vaginosis, with improved Nugent scores and treatment success rates. Probiotics represent a viable alternative to traditional antibiotic therapy, providing better patient outcomes with minimal side effects.
... The coded values of the factors and their levels (based on the results of preliminary experiments) are shown in Table 1. Design-Expert 8.0.5 software was applied to perform the RSM process and therefore to investigate the effects of variable factors on the system's response [21,22]. The experimental plan is shown in Table 2, where the actual order of the experimental arrangement is given randomly by the software. ...
Rheumatoid arthritis is considered a chronic systemic autoimmune disorder that may cause joint destruction. Triptolide, an active component isolated from Tripterygium wilfordii Hook.f., is considered to have promising potential for clinical use in treating rheumatoid arthritis. However, its clinical application has been limited by the narrow therapeutic window, side effects associated with plasma drug fluctuations, low oral bioavailability, and poor patient compliance with the long and frequent dosing regimen. An extended drug release preparation may address these limitations. The aim of this work was therefore to develop, formulate and optimize sustained release triptolide microspheres with poly (lactide-co-glycolide) (PLGA). Triptolide-loaded microspheres were prepared using PLGA as the matrix polymer, dichloromethane as the oil phase, and polyvinyl alcohol (PVA) as the matrix forming emulsifier. An oil-in-water (O/W) emulsion solvent evaporation technique was utilized to prepare the microspheres. Surface response methodology (RSM) coupled with central composite design (CCD) was used to optimize the formulation and a total of twenty formulations were prepared. PVA concentration (X1), PLGA concentration (X2), and theoretical drug content (X3) were selected as independent variables; and drug content (Y1), encapsulation efficiency (Y2), mean diameter (Y3) and the initial release during the first day (Y4) were taken as the response variables. The optimized formulation showed mean diameter of 42.36 μm, drug content of 7.96%, encapsulation efficiency of 80.16% and an initial release of 14.48%. The prepared microspheres exhibited a sustained release profile of triptolide in vitro over 4 weeks, which was wellfitted with a Korsmeyer-Peppas equation. However, the initial drug release (~14%) of triptolide-loaded microspheres was very high and should be specifically investigated in future studies. The results indicate that long-term sustained release microspheres of triptolide can be considered a strategy to overcome the low bioavailability and poor patient compliance with conventional triptolide tablets. The issue of initial burst release and in vivo evaluations should be specifically investigated in the future.
... This may limit the use of SNA 15 suppositories for the outpatient treatment of pneumonia in these regions. One way to remove the need for cold chain transport without increasing packaging requirements is to develop hollow-type (HT) suppositories, which can accommodate a solid, liquid or semi-solid within a hollow core [1,11,12]. This may improve the physical stability by encapsulating an amoxicillin-loaded SNA 15 core with a polymer shell that can maintain stability in temperatures above the melting point of SNA 15, which is 30-36 • C. ...
Rectal drug administration could offer advantages in the delivery of medicines for children by avoiding swallowability issues, improving stability and enabling administration by caregivers. This study aimed to evaluate the rectal bioavailability of hollow-type suppositories (HTS) and understand the effect of two chemical forms of amoxicillin: amoxicillin sodium (AS) or amoxicillin trihydrate (AMT). HTS were prepared by incorporating a lipophilic core containing the antibiotic with a polyethylene glycol (PEG) shell. Formulations were characterised in vitro, and the absolute bioavailability was determined in a rabbit model, while drug–base interactions were evaluated using X-ray diffraction crystallography (XRD), differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy. The in vitro amoxicillin release from AMT HTS was delayed, taking 27.3 ± 4.9 h to release 50% drug compared with 1.7 h for the AS HTS, likely due to solubility differences between AMT and AS. The presence of orthorhombic AMT and anhydrous AS crystals in respective HTS was confirmed via XRD and DSC. PEG shells were able to protect the drug chemical stability when stored at 25 °C/60% RH. Despite the difference in their in vitro release rates, a similar rectal bioavailability was found in both forms of amoxicillin (absolute bioavailability 68.2 ± 6.6% vs. 72.8 ± 32.2% for AMT HTS and AS HTS, respectively; p = 0.9682). Both HTS formulations showed little or no irritation to the rectal mucosa following a single dose.
Bacterial vaginosis is an infectious disease that has significantly affected women’s health. Metronidazole has been widely used as a drug for treating bacterial vaginosis. Nevertheless, the currently available therapies have been found to be inefficient and inconvenient. Here, we developed the combination approach of gel flake and thermoresponsive hydrogel systems. The gel flakes were prepared using gellan gum and chitosan, showing that the incorporation of metronidazole was able to provide a sustained release pattern for 24 h with an entrapment efficiency of >90%. Moreover, the gel flakes were incorporated into Pluronics-based thermoresponsive hydrogel using the combination of Pluronic F127 and F68. The hydrogels were found to exhibit the desired thermoresponsive properties, showing sol-gel transition at vaginal temperature. Following the addition of sodium alginate as a mucoadhesive agent, the hydrogel was retained in the vaginal tissue for more than 8 h, with more than 5 mg of metronidazole retained in the ex vivo evaluation. Finally, using the bacterial vaginosis infection model in rats, this approach could decrease the viability of Escherichia coli and Staphylococcus aureus with reduction percentages of more than 95% after 3 days of treatment, with the healing ability similar to normal vaginal tissue. In conclusion, this study offers an effective approach for the treatment of bacterial vaginosis.