Comparison of efficacy，safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia / 中国药房

OBJECTIVE To compare the efficacy， safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia （CAP）. METHODS A retrospective cohort study was conducted to screen and include CAP outpatients during the period of January to December 2021 in Lianyungang First People’s Hospital. They were divided into generic drug group （1 058 cases） and bid-winning drug group （1 121 cases） according to the drug source. Two groups were respectively given original and bid-winning Moxifloxacin hydrochloride tablets， 0.4 g each time， once a day. The efficacy indexes （clinical effective rate， remission time， treatment course， revisiting rate） and safety indexes （allergy， nervous system symptoms， etc.） were compared between the two groups； and the influence factors of clinical treatment failure were analyzed with multi-factor modified Poisson regression model. The economic indicators of the two drugs [quantity， consumption sum， defined daily doses （DDDs）， defined daily dose cost （DDDc）， price ratio， replacement rate] were compared. RESULTS There were no significant differences in the clinical effective rate， treatment course， revisiting rate， the incidence of nervous system symptoms and Q-T interval prolongation between the two groups （P＞0.05）. The remission time of original drug group was significantly shorter than that of bid-winning drug group， and the incidence of total adverse drug reaction， allergy reaction， gastrointestinal symptom reaction and hyperglycemia were significantly lower than those in bid-winning drug group（P＜0.05）. Multivariate Poisson regression analysis showed that bid-winning drug did not increase the risk of clinical treatment failure in CAP outpatients [RR＝1.132， 95%CI （0.883， 1.542）， P＝0.327]. However， antibiotic exposure history， more than 2 items of abnormal clinical manifestations and auxiliary examination all increased the risk of clinical treatment failure （P＜0.05）. Compared with before the implementation of centralized volume-based procurement policy， the quantity and DDDs of Moxifloxacin hydrochloride tablets increased significantly， while the consumption sum decreased significantly， DDDc of bid-winning drug decreased significantly， the price ratio of it to original drug decreased to 0.117， and the replacement rate increased to 69.44% after the implementation of centralized volume- based procurement policy. CONCLUSIONS Compared with original drug， bid-winning Moxifloxacin hydrochloride tablet shows reliable efficacy and obvious price advantage in the treatment of outpatient CAP， but the incidence of adverse drug reactions is higher.

Binder jet 3D printing composite bilayer tablet of extended-release printing technology in the study / 药学学报

Based on the dual needs of analgesia and anti-inflammation in trauma treatment, this study uses acetaminophen and moxifloxacin hydrochloride as active pharmaceutical ingredients and develops a composite bilayer tablet with a dual-phase drug release system by using binder jet 3D printing technology. Due to the complexity of the 3D printing process, there is an interaction between the various parameters. Through the optimization of the process, the relationship between the key process parameters can be determined more intuitively. In this study, the process of extended-release tablets was optimized to maintain the mechanical properties of the tablets while realizing the regulation of release. The full-factor experimental design of three central points 23 was used to analyze the factors that significantly affect the quality attributes of extended-release tablets and the interaction between factors. The optimal extended-release process parameters were obtained by the response optimizer: the inkjet quantity of the printing ink was 10 (about 13.8 pL), the powder thickness was 180 μm, and the running speed was 360 mm·s-1. The in vitro of release of 3D printed composite bilayer tablets showed that the in vitro of release of 3D printed tablets and commercially available tablets conformed to the Ritger-Peppas release model. The results of porosity showed that the immediate-release layer of the preparation has many pores and large pore size, and the dissolution of the immediate release layer within 15 min was greater than 85%. The internal pore size of the extended release layer is large, but it can still release slowly for up to 8 h, the mechanism may be related to the extended release of HPMC gelation. On the basis of verifying the rationality of the design goal of 3D printed composite bilayer tablets, this study also provides a theoretical basis for the preparation of 3D printing complex preparations.

Evaluation on the efficacy of moxifloxacin hydrochloride based on physiological pharmacokinetic models / 药学学报

This study is to establish and validation in vivo models of moxifloxacin based on the theory of physiologically based pharmacokinetics (PBPK), and then to predict the distribution of moxifloxacin in human venous return and organ such as lung, spleen and so on. The efficacy of moxifloxacin and its pharmaceutical preparations were quantified by comparing the pharmacokinetic parameters with the minimum inhibitory concentration of related pathogenic bacterium. The results showed that the anti-infection efficacy of pharmaceutical moxifloxacin preparation in the corresponding organs was basically the same. The PBPK model of moxifloxacin preparations can be more accurately described the pharmacokinetic of anti-infective drugs in human, it is suitable for the efficacy evaluation of anti-infective drugs and provides a strong basis for the corresponding scientific research and scientific supervision.

Bioequivalence of moxifloxacin hydrochloride tablets in healthy Chinese subjects / 中国临床药理学与治疗学

AIM: To study the pharmacokinetic characteristics of single-dose oral moxifloxacin hydrochloride tablets under fasting and fed conditions, and use moxifloxacin hydrochloride tablets produced by Bayer Pharma AG as a reference to compare the pharmacokinetic parameters of the two preparations, and evaluate the human bioequivalence of the two preparations. METHODS: A single-center, randomized, open, two-period, and self-crossover design was adopted to conduct a fasting and fed bioequivalence study of 23 healthy subjects each. The 0.4 g dose preparations were taken orally per cycle on fasting or fed administration. The plasma concentrations of moxifloxacin at different times after administration were determined by HPLC-MS/MS. The main pharmacokinetic parameters were calculated, and the bioavailability of the test preparation relative to the reference preparation was evaluated. RESULTS: After subjects in the fasting group took the test preparation T and the reference preparation R, the main pharmacokinetic parameters of moxifloxacin hydrochloride were: C

Two different chemoprophylaxis approaches after phacoemulsification surgery in one thousand patients in Iraq / 国际眼科杂志(Guoji Yanke Zazhi)

@#AIM: To evaluate the effectivity of the combination of intracameral moxifloxacin 0.1% with subconjunctival triamcinolone acetonide 4 mg as prophylaxis of infection and inflammation after phacoemulsification in comparison with topical medication treated group.<p>METHODS: A total one thousand patients with age range from 38 to 70 years old who scheduled for phacoemulsification were divided into 2 groups of no statistically significant differences in age, preoperative intraocular pressure(IOP)and central macular thickness(CMT), <i>P</i>=0.6, 0.9 and 0.8 respectively. The surgeries were done by 2 surgeons each one planned to use one method of prophylaxis at Eye Speciality Private Hospital, Baghdad, Iraq. For the 1^st group of patients(500)a topical moxifloxacin hydrochloride 0.5% and dexamethasone 0.1% eye drops were prescribed four times a day for 1mo postoperatively. For the 2^nd group intracameral(IC)diluted moxifloxacin at 0.1% with subconjunctival(SC)triamcinolone 4 mg in 0.4mL were administered at the conclusion of the surgery. Follow up visits were on the first postoperative day, 1wk, 1mo, and 3mo postoperatively. Anterior chamber(AC)reaction was examined during the 4 visits while IOP was measured during the last 3 and CMT was measured only in the last one.<p>RESULTS: The current clinical trial study compared 2 samples with 2 different prophylaxis methods. No endophthalmitis case reported in both group. By a 2-Sample <i>t</i>-test, the IC-treated group(group 2)had statistically significant lower AC cells at the 1^st day postoperative visit than the other group while there were no statistically significant differences at 1wk, 1 mo and 3mo visits between the 2 groups. There was no statistically significant difference at 3mo visits in IOP and CMT between the two groups. A breakthrough inflammation rate with the topical medication was 9.6% while in the other group(IC treated )was 4.0%. A significant IOP elevation ≥10 mmHg at 1mo in 2.4% within the topical medication group which was higher than the rate in the other group(0.8%).<p>CONCLUSION: In addition to the safety and effectivity of the combination of intracameral moxifloxacin and subconjunctival triamcinolone in preventing infection and inflammation after cataract surgery. The majority(480)of our included patients didn't require any topical postoperative medication that is cost saving for the patient, helped patients who were unable to administer topical medication, and decreased chance of complication related to patient poor adherence to postoperative medication.

Optimization of moxifloxacin hydrochloride tablets by formulationscreening and preparation process / 国际药学研究杂志

Objective To screen prescriptions for moxifloxacin hydrochloride tablets and optimize its preparation technology. Methods Taking the angle of repose,tap density,hardness,friability,disintegration time,tablet weight difference,and dissolution rate as indexes,the amount of each component,binder solvent,amount of binder,size of the mesh for granulation and particle drying process were investigated. The optimal formulation and process were determined based on the above results. Results With water as the binder solvent,binder volume of 6 ml,screen mesh number of 26 mesh,and finally drying 1 h at 50℃,the indicators of the tablet prepared met the quality requirements of tablet in the second part of the Pharmacopoeia of People′s Republic of China the 2015 ver-sion. And the dissolution profile was in good agreement with the commercially available preparation. Conclusion The quality of moxi-floxacin hydrochloride tablets prepared by the optimal formulation and process in this study is in accordance with the standard. The pre-scription and process can be used for the preparation of generic drugs of moxifloxacin hydrochloride tablets.

Study on the Migration of Residual Styrene to Moxifloxacin Hydrochloride and Sodium Chloride Injection from Five-layer Co-extrusion Bags / 中国药师

Objective:To establish a monitoring method for the detection of styrene monomer migration to moxifloxacin hydrochlo-ride and sodium chloride injection. Methods:A GC-MS method with a DB-5MS (30 m×0.25 mm,0.25 μm) column was used to determine styrene by the manner of large volume headspace purge-trap. Results:The linearity of styrene was good within the range of 0.009 1-0.364 μg·ml-1(r=0.999 9),and the average recovery of styrene in moxifloxacin hydrochloride and sodium chloride injec-tion was 99.4%(RSD=1.1%,n=9). After the detection of several batches of samples,the amount of styrene migration was all be-low the detection limit.Conclusion:The method can be used to measure the migration of styrene remained in five-layer co-extrusion in-fusion bags to moxifloxacin hydrochloride and sodium chloride injection.

Preparation of ophthalmic thermosensitive in situ gel of moxifloxacin hydrochloride and its release be¬havior in vitro / 中国药学杂志

CONCLUSION: Uniform design method should be used to optimize the formulation of MH loaded ophthalmic thermosensitive gel. The optimized formulation containing 230 mg·mL-1 P407 and 80 mg·mL-1 PI88 covered the ophthalmic temperature, which can serve as a potential candidate for ophthalmic application.

Determination of 2 Kinds of Components in Compound Moxifloxacin Nasal Drops by HPLC / 中国药房

OBJECTIVE:To establish a HPLC method for a simultaneous determination of moxifloxacin hydrochloride and ephedrine hydrochloride in compound moxifloxacin nasal drops.METHODS:The separation was performed on VP-ODS chromatographic column with column temperature at 30℃. The mobile phase consisted of phosphate buffer solution (which contained 0.02mol?L-1 sodium dihydrogen phosphate and 0.3% triethylamine, adjust pH to 3.0 by phosphoric acid) - methanol(60∶40) with flow rate at 1.0mL?min-1, detection wavelength at 214nm and sample size at 20?L. RESULTS: The linear ranges of moxifloxacin hydrochloride and ephedrine hydrochloride were 0.1～0.8(r=0.999 7,n=5) and 0.125～1.000?g (r=0.999 9, n=5), respectively,and their average recoveries were 98.94% (RSD=0.89%) and 99.67%(RSD=1.26%),respectively.CONCLUSION: The technique is simple, rapid, accurate, and reproducible, and it can be used as the quantity control of compound moxifloxacin nasal drops.

Preparation and Quality Control of Moxifloxacin Hydrochloride Gel / 中国药房

OBJECTIVE:To prepare moxifloxacin hydrochloride gel and to establish a quality control method for the gel.METHODS:The gel was prepared with carbopol934as base,the content of moxifolxacin hydrochloride was determined by HPLC and the stability of which was investigated.RESULTS:The linear range of moxifloxacin hydrochloride was0.4?g～3?g(r=0.9999),the average recovery was98.41%(RSD=1.42%,n=6).CONCLUSION:The gel is reasonable in perfor?mulation,satisfactory in stability,and accurate and reliable in quality control.

Compatible Stability of Moxifloxacin Hydrochloride and Sodium Chloride Injection with Four Kinds of Antihemorrhagic Drugs / 中国药房

OBJECTIVE:To observe the compatibility of moxifloxacin hydrochloride and sodium chloride injection with four kinds of antihemorrhagic drugs(etamsylate injection,aminomethylbenzoic acid injection,vitamin K1 injection,and aminocaproic acid injection).METHODS:The concentration of moxifloxacin in the mixture of Moxifloxacin Hydrochloride and sodium chloride injection with four kinds of antihemorrhagic drugs at 25℃ and 37 ℃ were determined by UV-spectrophotometry and dual wavelength spectrophotometry within 8 h.The changes of the mixture in appearance and pH were also observed.RESULTS:The mixture of moxifloxacin hydrochloride and sodium chloride injection with four kinds of antihemorrhagic drugs experienced no obvious changes in both contents of moxifloxacin and pH and appearance.CONCLUSION:The mixture of moxifloxacin hydrochloride and sodium chloride injection with four kinds of antihemorrhagic drugs was stable in contents of moxifloxacin and property.However,further studies remain to be done to investigate whether there are changes in the contents of the other four injections.