Diltiazem Hydrochloride Compounded Oral Solution

2014 ◽  
Author(s):  
Renato Pastore ◽  
Daniela Mentuccia ◽  
Dorina Ylli ◽  
Giordani Ilaria ◽  
Frontoni Simona

Author(s):  
Claudia Lefeber ◽  
Eva Tarau ◽  
Estelle Watson ◽  
Jiří Létal ◽  
Gregory Hammer

2021 ◽  
pp. 107815522199120
Author(s):  
Mélanie Hinterlang ◽  
Amandine Gendron ◽  
Thomas Fleury ◽  
André Rieutord ◽  
Anastasia Vrana ◽  
...  

Background Imatinib is a protein-tyrosine kinase inhibitor which is currently only commercially available as a tablet dosage form in the strength of 100mg and 400mg. The elaboration of new oral liquid formulations is suitable in pediatrics and for patients who have difficulties to swallow, notably in the absence of commercial forms. This enables the adaptation of dosage and secure the administration. Objectives The formulation of an oral pediatric solution of imatinib at a concentration of 30 mg/mL and the evaluation of its stability for the treatment of pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia. Methods The physicochemical stability parameters: appearance, pH, osmolality, and drug content of formulation were evaluated for 30 days when stored at 2–8°C. Concentration of solution was measured with a validated method using high performance liquid chromatography (HPLC) coupled with an absorbance UV detector. Equally, microbiological stability was performed. Results The remaining imatinib concentration was at least 95% of the initial concentration after 30 days stored in fridge temperature. No changes were observed regarding the physical properties of the formulation during the study period. Conclusions The stability study showed that the imatinib oral solution at a concentration of 30 mg/mL provides an alternative option at the commercial tablet dosage forms for pediatric patients and patients who have difficulties to swallow.


Author(s):  
Mariia D. Ivanova ◽  
Anatoliy I. Gozhenko ◽  
Tommy Crestanello ◽  
Dmytro D. Ivanov

<b><i>Introduction:</i></b> In observational studies, increased water intake improves kidney function but not in adults with CKD stage 3 and more. CKD WIT trial has shown a nonsignificant gradual decline in kidney function after 1 year of coaching to increase water intake (CIWI) [<xref ref-type="bibr" rid="ref1">1</xref>]. We propose that CIWI may benefit in CKD stage 1–2 (G1 and G2) and depends on functional renal functional reserve (RFR) [<xref ref-type="bibr" rid="ref2">2</xref>, <xref ref-type="bibr" rid="ref3">3</xref>]. <b><i>Objective:</i></b> Parallel-group randomized trial was aimed to determinate the effectiveness of CIWI dependence of estimated glomerular filtration rate (eGFR) stage and RFR in adults with CKD 1–2 stages. <b><i>Methods:</i></b> CKD WIT trial was taken as the basis for prospective multicenter randomized trial named “Early Coaching to Increase Water Intake in CKD (ECIWIC).” The primary outcome was the change in kidney function by eGFR from baseline to 12 months. Secondary outcomes included 1-year change in urine albumin/Cr ratio, and patient-reported overall quality of health (QH) ranged from 0 (worst possible) to 10 (best possible). CIWI aimed to have the diuresis being 1.7–2 L. There were 4 groups with nondiet sodium restriction which consisted of 31 patients each: 2 groups with CKD G1 and CKD G2, undergoing CIWI and 2 others with CKD G1 and CKD G2 without CIWI (Fig. 1a). Overall checks were made at 0, 6, and 12 months. RFR evaluation was performed using 0.45% sodium chloride oral solution. <b><i>Results:</i></b> Of our randomized 124 patients (mean age 53.2 years; men 83 [67%], 0 died), mean change in 24-h urine volume was 0.6 L per day in G1 with CIWI group and 0.5 L in G2. No statistically significant data on eGFR depending CIWI were obtained (Fig. <xref ref-type="fig" rid="f01">1</xref>b). However, the trend suggests that CIWI improves eGFR in CKD G1 (from 95 to 96 mL/min/1.73 m<sup>2</sup>) and preserves eGFR decline in CKD G2 (78–78). The QH values were also preserved (from 7 to 7 in G1 and G2 groups). Although coaching to maintain the same water intake did not preserve physiological and pathological eGFR decreasing in CKD G1-2 (G1 from 96 to 93, G2 from 76 to 73; <i>t</i> = 0.6, <i>p</i> = 0.29, and <i>p</i> ≤ 0.05 in all groups) and the QH was declined (from 7 to 6 in both groups). An individual analysis of the RFR has shown that patients with RFR more than 50% (G1 19 patients, 61%, and G2 13 patients, 42%) had reliable preservation of eGFR with its increase of 1.5 mL/min on CIWI, while patients with low functional renal reserve had a drop of eGFR at 1.1 mL/min/m<sup>2</sup> within 12 months. Patients with low normal serum sodium levels have shown worse results on CIWI. <b><i>Conclusions:</i></b> With CKD G1, the CIWI leads to the preservation of the renal function with its increase of GFR per 1 mL/min/m<sup>2</sup>/per year in comparison with the same water intake. In CKD G2, the CIWI prevents physiological and pathological loss of renal function, and RFR above 50% aids restoration of eGFR both in CKD G1-2. ECIWIC trial demonstrates benefit of CIWI in patients with CKD 1–2 and preserved RFR.


Author(s):  
Ying Huang ◽  
Xin Ran ◽  
Xiaoxi Xu ◽  
Sushmita Pradhan ◽  
Jiayu Sun ◽  
...  

2009 ◽  
Vol 6 (3) ◽  
pp. 238-248 ◽  
Author(s):  
S. Farhana ◽  
S. Shantakumar ◽  
Laxmi Narasu

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