Pharmacokinetic Comparison of Favipiravir Oral Solution and Tablet Formulations in Healthy Thai Volunteers.

This study compared the pharmacokinetics and safety of favipiravir oral solution with those of tablet formulations, which were agents repurposed to treat nonsevere coronavirus disease 2019 in Thailand. In an open-label, single-dose, randomized, crossover study, 24 healthy subjects under fasting conditions were randomly assigned to a single dose of 200 mg of favipiravir, either as an oral solution of 200 mg/15 mL (test product) or a tablet (reference product), separated by a 7-day washout period. Fifteen plasma samples were collected over 12 hours after drug administration. Plasma favipiravir levels were quantified using in-house developed ultra-high-performance liquid chromatography-tandem mass spectrometry. The test/reference geometric mean ratio along with 90%CI for the maximum plasma concentration, area under the concentration-time curve (AUC) to the time of the last quantifiable concentration, and AUC after single-dose administration, extrapolated to infinity were 115.3% (90%CI, 107.7%-123.3%), 100.4% (90%CI, 96.9%-104.0%), and 100.4% (90%CI, 96.8%-104.2%), respectively. These results were within the predefined acceptance criteria for bioequivalence (80.0%-125.0%). No adverse events were observed in either group. The oral solution formulation could offer the advantage of easier swallowing in broader patient groups.

Stability-indicating HPLC method to determine the stability of extemporaneously prepared vancomycin oral solution cups.

PURPOSE: To determine the stability of compounded sweetened vancomycin oral formulations in plastic unit dose cups stored up to 180 days under 2 temperature conditions: refrigeration (2°C-6°C) and room temperature (25°C with 60% relative humidity). METHODOLOGY: A stability-indicating high-performance liquid chromatography (HPLC) method was developed to analyze vancomycin in the presence of degradation peaks. The stability of extemporaneously compounded vancomycin solution stored in oral unit dose cups was investigated using this method. The tested vancomycin oral solutions were compounded formulations of 125 mg/2.5 mL and 500 mg/10 mL. Three oral unit dose cups from each storage condition were withdrawn and assessed for stability on days 0, 3, 7, 15, 22, 30, 90, 120, 150, and 180 as per United States Pharmacopeia guidelines. The assay of vancomycin was carried out by using a calibrated stability-indicating HPLC method. RESULTS: The stability-indicating HPLC assay showed that vancomycin completely degraded within 2 hours when exposed to highly acidic or basic pH conditions. No precipitation, cloudiness, or color changes were observed during the study under either temperature condition. The HPLC assay revealed that vancomycin oral solution cups retained greater than 90% of the initial concentrations of vancomycin for 30 days when stored at room temperature (25°C and 60% relative humidity) and for 180 days with refrigeration (2°C-6°C). CONCLUSION: Vancomycin oral formulations were stable for long-term storage periods beyond those specified in manufacture guidelines. Our data suggests the extended stability of vancomycin oral solutions compounded for hospital use can be extended.

Inhalation of Lanqin Oral Solutions Combined with Interferon in the Treatment of Children with Herpes Angina / 中国药师

Objective:To observe the effect and safety of the inhalation of Lanqin oral solutions combined with interferon in the treatment of children herpes angina. Methods:The children with herpes angina were randomly divided into two groups. On the basis of support treatment, the control group (57 cases) was intravenously treated with ribavirin, and the observation group (58 cases) was treated with the combined inhalation of interferon and Lanqin oral solutions. The time of transference cure, total efficiency and adverse drug reactions in the two groups were observed and compared. Results:The time of transference cure of the observation group was sig-nificantly shorter than that of the control group (P<0. 05) with higher total efficiency (P<0. 05). The adverse drug reactions were few and mild in the two groups. Conclusion:The inhalation of Lanqin oral solutions combined with interferon in the treatment of chil-dren with herpes angina is effective with short transference cure time, convenience of use and promising security, which is worthy of clinical application.

Content Determination of Baicalin and Phillyrin in Qinqiao Oral Solutions by HPLC / 中国药师

Objective: To establish an HPLC method for the determination of baicalin and phillyrin in Qinqiao oral solutions. Methods:The column was Inertsil ODS-SP(250 mm × 4. 6 mm, 5 μm). The mobile phase consisted of acetonitrile-phosphate buffer (11. 5 g ammonium dihydrogen phosphate was dissolved in water, and then 1ml phosphoric acid was added, finally the solution was di-luted to 1 000 ml by water)(75∶25). The flow rate was 1. 0 ml·min-1, the detection wavelength was at 278 nm and the column tem-perature was 25℃. Results:The calibration curve was linear within the range of 0. 203-4. 064 μg(r=0. 999 8) for baicalin and 0. 182-3. 648μg(r=0. 999 7) for phillyrin. The average recovery was 100. 9% with RSD of 1. 7% (n=5) and 100. 5% with RSD of 1. 4% (n=5), respectively. Conclusion:The method is simple, practicable, accurate and rapid, which can be applied in the determi-nation of baicalin and phillyrin in Qinqiao oral solutions.

Curative Effect Observation of Transfer Factor Oral Solutions as Adjunctive Therapy in Elderly Patients with Recurrent Respiratory Tract Infection (RRTI) / 中国药师

Objective:To observe the curative effect of transfer factor oral solutions as the adjunctive therapy in ederly patients with recurrent respiratory tract infection ( RRTI) . Methods:Totally 74 ederly patients with RRTI were selected and divided into the observation group and the control group randomly. The patients in the two groups were given anti-infection and symptomatic treatment during the acute stage of attack. The patients in the observation group were additionally given transfer factor oral solutions 10ml, po, tid for 3 months. The changes in serum immunoglobulin IgG, IgA and IgM levels in the two groups before and after the medical treat-ment were compared, and the clinical curative effect and adverse drug reactions ( ADR) were observed as well. Results: After the medical treatment, the serum IgG, IgA and IgM levels in the observation group were obviously increased than before (P0. 05). The total clinical efficiency in the observation group was much higher than that in the control group (P0. 05). Conclusion:Transfer factor oral solutions as the adjunctive therapy in ederly patients with RRTI has the favorable clinical curative effect and safety, and the underlying mechanisms may be concerned with the effect of enhancing serum immunoglobulin IgG, IgA and IgM levels, as well as humoral immune function.

Quality Investigation of Shuanghuanglian Oral Solutions from Different Manufactures / 中国药房

OBJECTIVE: To study the quality of Shuanghuanglian oral solutions from different manufactures. METHODS: The contents of baicalin, chlorogenic acid and forsythin in Shuanghuanglian oral solution on the market were determined by HPLC. The determination was performed on Agilent ZORBAX 80A Extend-C18 (150 mm?4.6 mm,5 ?m) column with column temperature set at 30 ℃. The mobile phase for baicalin consisted of methanol-water-acetic acid (50 ∶ 50 ∶ 1, V/V) at flow rate of 1.0 mL?min-1 and detection wavelength of 274 nm. The mobile phase for chlorogenic acid consisted of methanol-water-acetic acid (20 ∶ 80 ∶ 1, V/V) at flow rate of 0.8 mL?min-1 and detection wavelength of 324 nm. The mobile phase for forsythin consisted of acetonifrile-water (25 ∶ 75, V/V) at flow rate of 1.0 mL?min-1 and detection wavelength of 278 nm. RESULTS: Shuanghuanglian oral solutions from different manufactures conformed to the requirements of the first column of Chinese Pharmacopeia (2005 edition). The content differences of chlorogenic acid in Shuanghuanglian oral solutions were almost 3 times, which may be the cause of the difference of clinical efficacy. CONCLUSION: The minimum detection limit only has been established for the quality standard of Shuanghuanglian oral solution. It is suggested to improve the quality standard of Shuanghuanglian oral solution.