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Purpose: Methylphenidate hydrochloride, which blocks the reuptake mechanisms of dopamine and norepinephrine, is used in attention deficit hyperactivity disorder (ADHD) treatment. Methylphenidate has many general side effects including ocular findings. In this study, we investigated the long?term effects of methylphenidate treatment on functional and structural ocular parameters. Methods: In this prospective study, children with ADHD were evaluated. All patients underwent a detailed ophthalmic examination before methylphenidate treatment. All patients were examined in the 3rd, 6th, 9th, 12th months of methylphenidate treatment. Visual acuities, color vision, pupil diameters, static, dynamic and cycloplegic retinoscopy, intraocular pressure (IOP), anterior chamber depth (ACD), axial length (AL) were evaluated and recorded. Results: A total of 22 children were included in this study. The best?corrected visual acuities (BCVA) of all patients for both eyes were 0.0 logMAR, and 90.9% of patients had blue–purple color weakness before the treatment. After 1 year of treatment, none of the patients had any change in BCVA and color vision. However, an increase in myopic values of static retinoscopy and a decrease in hyperopic values of cycloplegic retinoscopy were found. Additionally, accommodation capacities were found to be decreased and AL was found to be increased significantly for both eyes. Pupil diameter, IOP, and ACD values did not change significantly. Conclusion: Our results suggest that patients with ADHD may have blue color vision deficiencies because of the decreased retinal dopamine levels. Additionally, structural and ocular parameters, especially accommodation capacity, may be affected by methylphenidate treatment.
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Objective:To observe the effect of methylphenidate hydrochloride (MPH) combined with mentalization-based family therapy (MBFT) on clinical efficacy and social function in children with attention deficit hyperactivity disorder (ADHD).Methods:Sixty-four children with ADHD diagnosed in Wuxi Children's Hospital and Affiliated Hospital of Jiangnan University from June 2019 to May 2021 were selected and divided into observation group ( n=32) and control group ( n=32) according to the random number table.Children in both groups received methylphenidate hydrochloride extended-release tablets, while those in the observation group were given additional MBFT.The duration of treatment was 12 weeks in both groups.The parent symptom questionnaire (PSQ), swanson nolan and pelham-version Ⅳ (SNAP-Ⅳ) parent Al scale, and Weiss impairment functional scale (WFIRS-P) were used to evaluate the effectiveness of treatment.Statistical analysis was performed by SPSS 25.0 statistical software.In particular, the χ2 test was used for counting data and the paired sample t test was used for comparison of measurement data between the two groups before and after treatment. Results:(1) All the PSQ dimension scores of patients in the observation group and the control group after treatment were significantly lower than those before treatment (all P<0.01). Compared with the control group after treatment, the PSQ dimension scores of personality and behavior problems ((1.25±0.15), (0.94±0.18), t=7.484, P<0.001), learning problems ((1.57±0.16), (1.32±0.20), t=5.522, P<0.001), psychosomatic disorders ((0.56±0.11), (0.44±0.13), t=3.986, P<0.001), impulse hyperactivity ((1.76±0.23), (1.54±0.25), t=3.663, P<0.001), anxiety ((0.94±0.12), (0.76±0.11), t=6.255, P<0.001) and hyperactivity index ((1.74±0.19), (1.51±0.16), t=5.238, P<0.001) decreased significantly in the observation group after treatment.(2) Compared with the pre-treatment period, the SNAP-Ⅳ scale scores of attention deficit, impulsivity-hyperactivity and oppositional defiance were significantly lower in both groups after treatment (all P<0.01); and compared with the control group, the SNAP-Ⅳ scale scores of the above three dimensions were significantly lower in the observation group (all P<0.01). (3) All six dimensions (family, learning and school, life skills, self-management, social activities, and risk-taking activities)of the WFIRS-P scale were significantly lower in the children in the observation group after treatment compared with those before treatment (all P<0.01), and all the six dimensions of the WFIRS-P scale were significantly lower in the observation group compared with those in the control group (all P<0.01). Conclusion:Methylphenidate hydrochloride extended-release tablets combined with MBFT can significantly improve the clinical symptoms and social function of children with ADHD.
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Unused medications have the possibility of being abused, causing serious harm to individuals who were not prescribed the drug. The Food and Drug Administration (FDA) recommends the proper disposal of unused prescribed medications to maintain safety and prevent environmental hazards. However, many of the current disposal techniques do not properly address safety. A drug disposal pouch containing granular activated carbon offers a unique disposal method to deactivate residual or expiredmedication in a convenient, effective, and safe manner. A robust and validated method for methylphenidate hydrochloride and loxapine succinate was developed using high-performance liquid chromatography (HPLC) and the deactivation efficiency of the disposal system was tested. Methylphenidate hydrochloride was analyzed on a C18 analytical column (250mm × 4.60mm, 100?) using acetonitrile-water (0.05％ (v/v) trifluoroacetic acid) as the mobile phase at a flow rate of 1.0mL/min with a run time of 15min and retention time of 7.8min. Loxapine succinate was separated on a C8100? (250 mm × 4.6 mm, 5 μm) column maintained at 25 °C using a flow rate of 1.0mL/min. The run time was 10min and the retention time of the drug was around 4.6min.Mobile phase was composed of acetonitrile and water (0.3％ triethylamine) at pH 3.0 as 40:60 (v/v). Reference standard solutions (100 μg/mL) for both drugs were prepared by dissolving in mobile phases. These methods provide good linearity (R2 = 0.999) over the range of 5–100 μg/mL for methylphenidate hydrochloride and 0.1–100 μg/mL for loxapine succinate. The assay methods were successfully applied to study the deactivation of these drugs.
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Objective: To study the preparation method and process optimization of methylphenidate hydrochloride biphasic controlled-release osmotic pump tablets.Methods: Based on the preparation technology of double-layer osmotic pump slow-release tablets and combined with the principle of biphasic drug release behavior, the two-release preparation with two different release phases was prepared.Through the single-factor investigation of the drug-containing layer and the booster layer, the amount of the auxiliary materials was determined.The optimum compression method and the optimum coating parameters were obtained by studying the process parameters of tabletting and coating.Results: The prepared methylphenidate biphasic controlled-release osmotic pump tablets had two different release phases.The methylphenidate hydrochloride controlled-release osmotic pump tablets produced by the optimal formulat were good in appearance and reproducibility of drug content.In vitro release curves showed that the drug was released rapidly in the intial 0-2 hour time interval and was in line with zero-order release in 2-10 hour with good reproducibility.Conclusion: The preparation method is scientific, simple and complete, and can be used for preparation of methylphenidate hydrochloride biphasic controlled-release osmotic pump tablets.
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Objective To explore the influence of Methylphenidate Hydrochloride prolonged-release tablets on the cognitive processing of children with attention deficit hyperactivity disorder (ADHD).Methods Thirty ADHD children and 30 healthy controls were enrolled in this study,and the ADHD subjects were treated with Methylphenidate Hydrochloride prolonged-release tablets for (28 ± 3) days.Pre-test and post-test by the Das-Naglieri:Cognitive Assessment System(DN:CAS) were done to evaluate the cognitive function of all individuals.The differences of cognitive processing in pre-treatment and post-treatment of ADHD group with healthy control group were compared.The difference between before and after treatment of ADHD was also compared.Results Compared with healthy control group,there were lower of planning score [(21.86 ± 4.61) scores vs.(29.33 ± 5.06) scores],attention score [(25.00 ± 4.57) scores vs.(29.83 ± 3.79) scores],and the total scores [(111.93 ± 13.95) scores vs.(127.26 ±15.53) scores] in ADHD group,and there were significant differences (t =-5.976,-4.455,-4.023,all P ＜0.05).The matching number,planned codes,planned connections,expressive attention,number detection and receptive attention scores were also lower in ADHD group,and there were significant differences (t =-4.787,-3.703,-4.991,-2.216,-2.488,-3.219,all P ＜ 0.05).Compared with healthy control group,there were lower of planning score with significant difference [(25.53 ± 4.98) scores vs.(29.33 ± 5.06) scores,t =-2.931,P ＜ 0.05] in ADHD group after treatment,matching number and planned codes were lower with significant difference (t =-2.654,-2.044,all P ＜ 0.05) in ADHD group after treatment.In ADHD group,the scores of planning [(25.53 ± 4.98)scores vs.(21.86 ± 4.61) scores],simultaneous processing [(36.10 ± 7.10) scores vs.(34.13 ± 6.04) scores],attention [(27.90 ± 5.69) scores vs.(25.00 ± 4.57) scores] and the total score [(121.50 ± 16.55) scores vs.(111.93 ± 13.95) scores] were significantly higher after treatment than that before treatment and there were significant differences (t =-5.679,-2.949,-3.869,-5.963,all P ＜ 0.05);matching number,planned codes,planned connections,nonverbal matrices,number detection,receptive attention and word series were significantly higher after treatment than that before treatment,and there were significant differences (t =-2.528,-3.209,-3.890,-2.276,-4.489,-2.208,-2.373,all P ＜ 0.05).Conclusion The Methylphenidate Hydrochloride prolonged-release tablets can improve the function of cognitive processing in children with ADHD,especially in attention.
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Objective To explore the influence of Methylphenidate Hydrochloride prolonged-release tablets on the cognitive processing of children with attention deficit hyperactivity disorder (ADHD).Methods Thirty ADHD children and 30 healthy controls were enrolled in this study,and the ADHD subjects were treated with Methylphenidate Hydrochloride prolonged-release tablets for (28 ± 3) days.Pre-test and post-test by the Das-Naglieri:Cognitive Assessment System(DN:CAS) were done to evaluate the cognitive function of all individuals.The differences of cognitive processing in pre-treatment and post-treatment of ADHD group with healthy control group were compared.The difference between before and after treatment of ADHD was also compared.Results Compared with healthy control group,there were lower of planning score [(21.86 ± 4.61) scores vs.(29.33 ± 5.06) scores],attention score [(25.00 ± 4.57) scores vs.(29.83 ± 3.79) scores],and the total scores [(111.93 ± 13.95) scores vs.(127.26 ±15.53) scores] in ADHD group,and there were significant differences (t =-5.976,-4.455,-4.023,all P ＜0.05).The matching number,planned codes,planned connections,expressive attention,number detection and receptive attention scores were also lower in ADHD group,and there were significant differences (t =-4.787,-3.703,-4.991,-2.216,-2.488,-3.219,all P ＜ 0.05).Compared with healthy control group,there were lower of planning score with significant difference [(25.53 ± 4.98) scores vs.(29.33 ± 5.06) scores,t =-2.931,P ＜ 0.05] in ADHD group after treatment,matching number and planned codes were lower with significant difference (t =-2.654,-2.044,all P ＜ 0.05) in ADHD group after treatment.In ADHD group,the scores of planning [(25.53 ± 4.98)scores vs.(21.86 ± 4.61) scores],simultaneous processing [(36.10 ± 7.10) scores vs.(34.13 ± 6.04) scores],attention [(27.90 ± 5.69) scores vs.(25.00 ± 4.57) scores] and the total score [(121.50 ± 16.55) scores vs.(111.93 ± 13.95) scores] were significantly higher after treatment than that before treatment and there were significant differences (t =-5.679,-2.949,-3.869,-5.963,all P ＜ 0.05);matching number,planned codes,planned connections,nonverbal matrices,number detection,receptive attention and word series were significantly higher after treatment than that before treatment,and there were significant differences (t =-2.528,-3.209,-3.890,-2.276,-4.489,-2.208,-2.373,all P ＜ 0.05).Conclusion The Methylphenidate Hydrochloride prolonged-release tablets can improve the function of cognitive processing in children with ADHD,especially in attention.
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OBJECTIVE:To establish a method for the determination of related substances in Methylphenidate hydrochloride for injection. METHODS:HPLC method was adopted. The determination was performed on Waters symmetry C18 column with mo-bile phase consisted of methanol-0.01 mol/L potassium dihydrogen phosphate solution(60:40,V/V)at the flow rate of 1.0 mL/min. The detection wavelength was set at 210 nm,the column temperature was 35 ℃ and sample size was 10 μL. RESULTS:The linear range of impurity A and B were 0.02-3.0 μg/mL(r=0.9998). The limits of quantitation were 0.2,0.6 ng,and the limits of detec-tion were 0.06,0.2 ng,respectively. RSDs of precision,stability and reproducibility were all lower than 2.0%;recoveries were 98.2%-100.0%(RSD=0.56%,n=9),98.0%-100.3%(RSD=0.70%,n=9),respectively. CONCLUSIONS:The method is sim-ple,accurate and suitable for the determination of related substance in Methylphenidate hydrochloride for injection.
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Objective:To establish the drug release determination conditions and method for methylphenidate hydrochloride bipolar controlled release osmotic pump tablets. Methods: The drug release of the tablets was determined by HPLC using a Diamonsil C18 (250 mm × 4. 6 mm, 5 μm) column with acetonitrile-KH2 PO4 (0. 02 mol·L-1 ,and pH was adjusted to 3. 0 by 1% H3 PO4 solution) (30∶ 70) as the mobile phase at a flow rate of 1 ml·min-1 , the column temperature was 35 ℃ and the injection volume was 20 μl. The effects of release medium, release apparatus and rotation speed on the release of methylphenidate hydrochloride bipolar controlled release osmotic pump tablets were studied as well. Results:The established drug release determination method had a good linear rela-tionship within the range of 1. 0-24. 0 μg·ml-1(r=0. 999 5), and the average recovery was 100. 5%(RSD=1. 58%, n = 6). Un-der the conditions of 900 ml pH 3. 0 phosphate buffer solution as the release medium and the rotation speed of 50 r·min-1 , the drug was quickly released in 0-2h, and then the release behavior was complied with a zero-level model in vitro in 2-10h with the release e-quation of Q=5. 505t+44. 221(r=0. 994 5). Conclusion:The method is simple, accurate and reliable, and suitable for the quality control of methylphenidate hydrochloride bipolar controlled release osmotic pump tablets.
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Objective To study the anti-fatigue effect of methylphenidate hydrochloride oral fast dissolving films (MPH-OFDF) and its mechanism .Methods 60 mice were randomly divided into 6 groups as:normal control group (physiological sa-line) ,model group (physiological saline) ,Yiqiyangxue oral liquids positive group (7 .00 mg/kg) ,MPH-OFDF high-dose group (5 .20 mg/kg) ,MPH-OFDF middle-dose group (2 .60 mg/kg) and MPH-OFDF low-dose group (1 .30 mg/kg) .Besides the normal control group ,model group and positive group were orally administered ,the other groups are administered with the drug once daily sublingually daily for consecutive 15 days .The mice were put in the load-weighted swimming test 30 min after the last oral administration ,then the anti-fatigue effect was assessed based on recording exhausting swimming time and detec-ting the levels of serum lactale dehydrogenase (LDH) ,creatine kinase (CK) ,triglycerides (TG) in mice .Results Compared with control group ,the middle-dose and the high-dose MPH could prolong the exhausting swimming time (P<0 .05 ,P<0 .01) and decrease the activity of LDH and CK significantly (P<0 .05 ,P<0 .01);in addition the middle-dose MPH could decrease the content of TG (P<0 .05) .Conclusion The MPH had marked anti-fatigue effect that may be associated with reduced ser-um LDH ,CK and TG .
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Objective:To investigatethe transdermal delivery characteristics of methylphenidate hydrochloride (MPH) in vitro. Methods: Characteristics of MPH crossing nude rats skin were studied with Franz diffusion cells. A high performance liquid chromatographic (HPLC) method was established to determine the concentration of MPH crossed the skin. The permeability coefficient (P), steady state flux (J) and lag time(LT) for MPH through the skin of nude rats treated with various enhancers were compared with those of control. Results: The permeability coefficient increased with the increase of MPH concentration. The penetration of MPH through nude rats skin was obviously enhanced by 8%Azone and 5%propylene glycol (P