scholarly journals A Novel Oral Syringe for Dosing and Administration of Multiparticulate Formulations: Acceptability Study in Preschool and School Children

Pharmaceutics ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 806 ◽  
Author(s):  
Justyna Katarzyna Hofmanová ◽  
Joanne Bennett ◽  
Alastair Coupe ◽  
Jeremy A. Bartlett ◽  
Andrew Monahan ◽  
...  
Keyword(s):  
Dosage Form ◽  
Dose Range ◽  
Spring Water ◽  
The Novel ◽  
Point Scale ◽  
Complete Sample ◽  
Dose Volume ◽  
Flexible Dosing ◽  
Lower Dose Range ◽  
Sample Intake

The popularity of multiparticulate formulations (MPs) as a paediatric dosage form continues to increase. MPs comprise of multiple small units that are easy-to-swallow. Currently, MPs are commonly manufactured into unit doses that are either swallowed whole or opened prior to administration. While this is an acceptable approach, dosing is envisioned to be optimised with a “standard” paediatric device which can better harness the flexible dosing potential of MPs. We evaluated a novel oral syringe (SympfinyTM, HS Design, Morristown, NJ, USA) that is being developed as a tool to dispense and administer MPs to children. Forty children, 4–12 years old, received 0.5, 1.2, and 2.0 mL doses of placebo MPs using the oral syringe with spring water or a drink of choice to complete sample intake. Acceptability was recorded as those able to completely swallow the dose and participants also rated dose acceptability on a 5-point scale. The ability to completely swallow the dose decreased as dose volume increased; the smallest dose was completely swallowed by 87.5% (35/40) children, and 69.4% (27/39) of children confirmed their willingness to take the sample as a daily medicine. Larger doses, 1.2 and 2.0 mL, gave values of 55% and 57.5% for the doses completely swallowed and 58.8% and 51.72% for willingness to take the sample as a daily medicine, respectively. Use of a drink of choice showed no increase in swallowability as compared with water. The novel oral syringe being developed is an appropriate device for dispensing doses flexibly and administering neutral tasting MPs directly to the mouth in the lower dose range without the need for a co-administration vehicle in children aged 4–12 years.

scholarly journals A Novel Oral Syringe for Dosing and Administration of Multiparticulate Formulations: Acceptability Study in Preschool and School Children

2020 ◽  
Author(s):  
Justyna Hofmanová ◽  
Joanne Bennett ◽  
Alastair Coupe ◽  
Jeremy Bartlett ◽  
Andrew Monahan ◽  
...  
Keyword(s):  
Dosage Form ◽  
Dose Range ◽  
Spring Water ◽  
The Novel ◽  
Point Scale ◽  
Complete Sample ◽  
Dose Volume ◽  
Flexible Dosing ◽  
Lower Dose Range ◽  
Sample Intake

The popularity of multiparticulate formulations (MPs) as a paediatric dosage form continues to increase. MPs comprise of multiple small units that are easy-to-swallow. Currently, MPs are commonly manufactured into unit doses that are either swallowed whole or opened prior to administration. While this is an acceptable approach, dosing is envisioned to be optimized with a ‘standard’ paediatric device which can better harness the flexible dosing potential of MPs. We evaluated a novel oral syringe (SympfinyTM) that is being developed as a tool to dispense and administer MPs to children. Forty children, 4-12 years old, received 0.5, 1.2, and 2.0 mL doses of placebo MPs using the oral syringe with spring water or a drink of choice to complete sample intake. Acceptability was recorded as those able to completely swallow the dose and participants also rated dose acceptability on a 5-point scale. The ability to completely swallow the dose decreased as dose volume increased; the smallest dose was completely swallowed by 87.5% (35/40) children, and 69.4% (27/39) of children confirmed their willingness to take the sample as a daily medicine. Larger doses, 1.2 and 2.0 mL, gave values of 55% and 57.5% for the doses completely swallowed and 58.8% and 51.72% for willingness to take the sample as a daily medicine, respectively. Use of a drink of choice showed no increase in swallowability as compared with water. The novel oral syringe being developed is an appropriate device for dispensing doses flexibly and administering neutral tasting MPs directly to the mouth in the lower dose range without the need for a co-administration vehicle in children aged 4-12 years.

scholarly journals Anti-arthritic and gastroprotective activities of Ardisia crispa root partially mediated via its antioxidant effect

2017 ◽  
Vol 15 (1) ◽  
Author(s):  
Roslida Abdul Hamid ◽  
Lau Moi Fong ◽  
Yeong Looi Ting
Keyword(s):  
Antioxidant Activities ◽  
Inflammatory Diseases ◽  
Dose Range ◽  
Antioxidant Effect ◽  
Total Phenolic ◽  
Chromatography Analysis ◽  
Gas Chromatography Analysis ◽  
Tnf Α ◽  
Ulcer Model ◽  
Lower Dose Range

AbstractBackgroundThunb A.DC (Myrsinaceae), commonly known as “hen’s eyes”, has been traditionally used in treating various inflammatory diseases. The present study evaluated anti-arthritic, gastroprotective and antioxidant activities ofMethodsAnti-arthritic activity was evaluated in complete Freund adjuvant (CFA)-induced adjuvant arthritis and gastroprotective effect was studied in the ethanol-induced ulcer model in rats. ACRH was further isolated to yield quinone-rich fraction (QRF) and both were analyzed for their total phenolic content, total flavonoid content and antioxidant activities in various antioxidant assays. Both ACRH and QRF were also analyzed for the quinone composition via gas chromatography analysis.ResultsACRH exerted significant reduction of IL-1β and TNF-α at a lower dose range in CFA-induced arthritis, as well as exhibited its cytoprotective effect against ethanol-induced ulcer lesion via involvement of mucosal nonprotein sulfhydryl (NP-SH) groups. ACRH also showed higher phenolic and flavonoid contents, as well as better antioxidant activities than QRF.ConclusionsThese findings demonstrated the plant as a potential anti-inflammatory agent, with ACRH succeeded in inhibiting both arthritic and ulcerogenic effect, possibly mediated via its antioxidant effect.

Synthesis and Characterization of Novel ZnO Nanophosphors

2014 ◽  
Vol 938 ◽  
pp. 145-148
Author(s):  
Manmohan Singh Kurrey ◽  
Bhoopendra Dhar Diwan
Keyword(s):  
Zinc Oxide ◽  
Dose Range ◽  
Synthesis And Characterization ◽  
The Novel ◽  
Maximum Value ◽  
Solgel Method ◽  
Thermo Luminescence

In this paper, the novel ZnO nanophosphors is synthesized by solgel method. The study exposed ZnO nanophosphors samples in Gamma (y) radiation to investigate their thermo-luminescence (TL) intensity as a function of temperature. The thermo-luminescence response has been studied in the dose range 0.291.16 kGy and it is observed that the thermo-luminescence response increases with increase in the dose. Moreover, the TL intensity increases with temperature and attains its maximum value near 200 Cand decreases after this temperature. Keywords: Dosimetry; Thermo-luminescence; Zinc oxide; Nanophosphors.

scholarly journals TRANSLOCATIONS, THE PREDOMINANT CAUSE OF TOTAL STERILITY IN SONS OF MICE TREATED WITH MUTAGENS

Genetics ◽  
1974 ◽  
Vol 76 (1) ◽  
pp. 73-91
Author(s):  
Nestor L A Cacheiro ◽  
Liane Brauch Russell ◽  
Margaret S Swartout
Keyword(s):  
Male Sterility ◽  
Dose Range ◽  
Butylated Hydroxytoluene ◽  
X Rays ◽  
Position Effects ◽  
Partial Sterility ◽  
X Irradiation ◽  
Lower Dose Range ◽  
Y Cells ◽  
Very High

ABSTRACT Histological and cytological analyses of the testes were carried out in 42 sterile sons of males treated in the spermatozoal or spermatid stage with 250 mg/kg ethyl methanesulfonate (EMS) alone or after prefeeding with butylated hydroxytoluene (BHT); or treated with 200 R X-rays. Of the 42 sterile males, 17 had some mature spermatids, nine were blocked at diakinesis, 15 were blocked in pachytene, and one lacked spermatogenic cells altogether, having Sertoli cells only. Mitotic (spermatogonial) metaphases could therefore be analyzed in 41 of the males and meiotic configurations in 26.—(1) None of the males showed abnormalities in chromosome number, such as monosomy, trisomy, or mosaicism for either of these conditions. Certain classes of chromosome abnormalities that have been found associated with male sterility in other investigations, namely trisomies, XXY's, and X-autosome translocations, are not expected from treatment of 19A + Y cells when F1 males are studied. (2) A very high percentage of the sterile males carried translocations. Direct meiotic evidence for this was found in 22 of the animals. In addition, 11 of the 16 that were blocked (or virtually blocked) in pachytene, and thus could be analyzed in mitosis only, consistently showed one abnormally short chromosome (or, one short plus one long), which presumably had resulted from unequal exchange (or sizable deficiency). Of the meiotically detected translocation males, 1 carried a T(A;Y), 17 had single autosomal translocations, and 4 had multiple autosomal rearrangements involving three, four, four, and six breaks, respectively. In addition, three males showed failure of X-Y pairing. (3) Translocations that cause sterility, rather than partial sterility, in males appear to be those in which at least one of the breaks occurs close to one end of a chromosome. The mitotic and meiotic evidences for this were found to be correlated. (4) It is proposed that many cases of induced F1 male sterility may be the result of position effects produced when paracentromeric regions are translocated to euchromatic regions of certain other chromosomes. Since many translocations that produce partial sterility in the female cause complete sterility in the male, the male must be assumed to be more susceptible to disturbances of fertility by the postulated mechanism. (5) There is evidence that EMS, especially in the lower dose range, more often breaks chromosomes near one of their ends than does X-irradiation.

SENSITIVITY OF THE RAT TO INCREASING DOSES OF DEXTRAN

1962 ◽  
Vol 40 (6) ◽  
pp. 697-702 ◽  
Author(s):  
Gaetan Jasmin ◽  
Pierre Bois ◽  
Mai-Shian Su
Keyword(s):  
Toxic Effect ◽  
Intravenous Injection ◽  
Dose Response ◽  
Dose Range ◽  
Response Relationship ◽  
Dose Response Relationship ◽  
Toxic Dose ◽  
Lower Dose Range ◽  
Higher Doses ◽  
Adrenalectomized Rats

Increasing doses of dextran, a commercial 6% solution, were injected intravenously into both intact and adrenalectomized rats to evaluate the dose–response relationship. The minimum dose capable of producing an edema with 100% incidence was approximately 30 mg/kg in intact and only 4 mg/kg in adrenalectomized rats. Lower doses produced responses of decreasing intensity and incidence with a longer period of onset. Conversely, higher doses resulted in a shorter period of onset and a more intense reaction until a toxic dose was reached, beyond which cyanosis and shock appeared. Adrenalectomized rats reacted similarly to intact ones except that their response occurred at a lower dose range; they could not withstand the toxic effect of higher doses and died of circulatory failure. The fact reported by other workers that the edema is more intense and appears more rapidly after intravenous injection of minute rather than large quantities of dextran was not confirmed; the existence of a "critical dose" that does not produce any edema was not substantiated.

scholarly journals DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRICMETHOD FOR QUANTITATIVE ESTIMATION OF GLIPIZIDEIN PHARMACEUTICAL DOSAGE FORM

2020 ◽  
pp. 104-107
Author(s):  
ANUJA SURYAWANSHI ◽  
AFAQUEANSARI ◽  
MALLINATH KALSHETTI
Keyword(s):  
Dosage Form ◽  
Limit Of Detection ◽  
Quantitative Estimation ◽  
The Novel ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Novel Method ◽  
Bulk Drug ◽  
Development And Validation

Objective: The present work is aimed to develop a simple, rapid, selective and economical UV spectrophotometric method for quantitative determination of Glipizideinbulk and pharmaceutical dosage form. Methods: In this method Dimethyl Form amide (DMF) was used as solvent, the absorption maxima was found to be275 nm in DMF. The developed method was validated for linearity, accuracy, precision, ruggedness, robustness, LOD and LOQ in accordance with the requirements of ICH guideline. Results: The linearity was found to be 10-60 µg/ml having linear equation y=0.017x-0.006 with correlation coefficient of 0.997. The% recovery was found to be in the range of 98.7-100%. The % RSD for intra-day and inter-day precision was found to be 0.569923 and 0.40169 respectively. The limit of detection (LOD) and limit of quantification (LOQ) was found to be3.06 µg/ml and 9.27 µg/ml respectively. Conclusion: The developed method was validated as per ICH Q2(R1) guidelines. The novel method is applicable for the analysis of bulk drug in its pharmaceutical dosage form.

scholarly journals Feasibility of using calibrated cone-beam computed tomography scans to validate the heart dose in left breast post-mastectomy radiotherapy

2020 ◽  
Vol 48 (6) ◽  
pp. 030006052092916
Author(s):  
Bin Tang ◽  
Jiabao Ma ◽  
Jinghui Xu ◽  
Jie Li ◽  
Shengwei Kang ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Cone Beam Computed Tomography ◽  
Dose Range ◽  
Left Breast ◽  
Cone Beam ◽  
Heart Volume ◽  
Absolute Increase ◽  
Heart Dose ◽  
Dose Volume ◽  
Computed Tomography Scans

Objective In post-mastectomy radiotherapy, high-conformal techniques are a valid method for determining the dose distribution around a target. However, the proximity of critical structures is a reason for concern. This study aims to evaluate the feasibility of using calibrated cone-beam computed tomography (CBCT) scans as a valid tool for a timely heart dose evaluation. Methods A retrospective analysis was conducted on 170 retrospective CBCT scans of 17 patients who underwent high-conformal post-mastectomy irradiation. The delivered doses that were calculated using personalized calibrated CBCT were compared with the doses planned, using the dose–volume histogram dosimetric parameters. Results The heart volume that was evaluated using CBCT presented a mean increase of 6%; this discrepancy impacted the heart dose in 4 of 17 patients, with an absolute increase of V25 Gy (range, 2.5%–7.6%) and an increase in the mean dose (range, 1.1–3.4 Gy). The dose for the target, ipsilateral lung, and contralateral breast remained unchanged. Conclusion Using CBCT to monitor the dose that is delivered to the heart is feasible, allowing for a timely shift to an adaptive plan if clinically necessary.

High-dose cisplatin administration without hypertonic saline: observation of disabling neurotoxicity.

1985 ◽  
Vol 3 (10) ◽  
pp. 1373-1378 ◽  
Author(s):  
S S Legha ◽  
I W Dimery
Keyword(s):  
Peripheral Neuropathy ◽  
Hypertonic Saline ◽  
Dose Range ◽  
Neck Region ◽  
Dose Schedule ◽  
High Dose ◽  
Minor Response ◽  
Forced Diuresis ◽  
Limited Experience ◽  
Lower Dose Range

Nephrotoxicity of cisplatin can be ameliorated with intravenous (IV) hydration and forced diuresis with mannitol. Cisplatin has recently been used with hypertonic saline which allows administration of higher doses amounting to 40 mg/m2/d for 5 days, without significant nephrotoxicity. In this report we describe our experience with administration of cisplatin in a dose range of 30 to 40 mg/m2/d for 5 days, administered with IV hydration alone. Thirteen patients with recurrent carcinoma of the head and neck region were treated with high-dose cisplatin along with 5-fluorouracil (5-FU) used as a continuous infusion. Eight patients received a total of 21 courses of cisplatin with the higher dose range (40 mg/m2 for 5 days) and the remainder received 11 courses with the lower dose range. The renal toxicity was minimal but the myelo-suppression was intense, frequently requiring hospitalization for the treatment of infections associated with neutropenia. Furthermore, we encountered severe peripheral neuropathy in five patients, four of whom developed major difficulties with ambulation. Six patients achieved objective regression of their tumor, two had minor response, and five failed to respond to chemotherapy. The study was terminated because of serious nonrenal toxicity from the high-dose cisplatin. Based on our limited experience, we believe that IV hydration alone, without the use of hypertonic saline, allows administration of high-dose cisplatin without significant nephrotoxicity. However, cisplatin used in a dose schedule of 40 mg/m2 for 5 days for more than three courses resulted in a disabling form of peripheral neuropathy.

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