PP-017 Physicochemical and microbiological stability of a new paediatric oral solution of clonidine

2017 ◽  
Author(s):  
C Verlhac ◽  
D Lannoy ◽  
F Bourdon ◽  
M Titecat ◽  
E Frealle ◽  
...  
Keyword(s):  
Oral Solution ◽  
Microbiological Stability

scholarly journals Preparation of Galla Chinensis Oral Solution as well as Its Stability, Safety, and Antidiarrheal Activity Evaluation

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Yi Yang ◽  
Huihui Luo ◽  
Xu Song ◽  
Li Yu ◽  
Juan Xie ◽  
...  
Keyword(s):  
Castor Oil ◽  
Lethal Dose ◽  
Pharmaceutical Preparations ◽  
Oral Solution ◽  
Tannin Content ◽  
Tannin Extract ◽  
Fluid Accumulation ◽  
Microbiological Stability ◽  
Antidiarrheal Activity ◽  
Oral Acute Toxicity

Background of the Study. As a widely used traditional medicine, Galla Chinensis is rich in tannins. However, there are few detailed studies about pharmaceutical preparations of Galla Chinensis tannin extract (GTE). In the present experiments, for better application and to investigate the possibility that Galla Chinensis tannin extract can be used as an antidiarrheal drug, we prepared Galla Chinensis oral solution (GOS). Materials and Methods. GOS was prepared with GTE, and its physicochemical and microbiological stability was evaluated. The oral acute toxicity of GOS was calculated by the 50% lethal dose (LD50). The antidiarrheal activity was determined in a castor oil-induced diarrhea model in mice through diarrhea symptoms, fluid accumulation ratio, and percentage of distance moved by charcoal meal. Results. The tannin content of GTE was 47.75%. GOS could endure a high temperature without a significant decrease of tannin content. After storage for six months, the tannin content of GOS was still more than 90%. GOS was determined to be nontoxic. Meanwhile, GOS showed significant antidiarrheal activity in a castor oil-induced diarrhea model in mice (P<0.01). Conclusion. The results suggested that GOS is an effective and stable antidiarrheal drug that can be used to complement other therapies.

scholarly journals Physicochemical and Microbiological Stability of a New Oral Clonidine Solution for Paediatric Use

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Camille Verlhac ◽  
Damien Lannoy ◽  
Florence Bourdon ◽  
Marie Titecat ◽  
Emilie Frealle ◽  
...  
Keyword(s):  
Membrane Filtration ◽  
Degradation Products ◽  
Potassium Citrate ◽  
Oral Solution ◽  
Opiate Withdrawal ◽  
Potassium Sorbate ◽  
Physical Parameters ◽  
Forced Degradation ◽  
Microbiological Stability ◽  
Glass Bottles

AbstractBackgroundAs many drugs are unavailable for paediatric use, hospital pharmacies are often required to develop suitable formulations themselves. Clonidine is commonly used in paediatrics (in severe hypertension, in opiate withdrawal syndrome, in tics and Gilles de la Tourette syndrome or in anaesthetic premedication) but no appropriate formulation has been drawn up. The aims of this work were to develop an oral solution of clonidine dedicated to children and to assess its physicochemical and microbiological stability.MethodsFormulation of an oral solution of clonidine hydrochloride suitable for neonates and paediatrics was developed using the active pharmaceutical ingredient (API), with as few excipients as possible and without any complex excipient vehicle. A stability study was made according to GERPAC-SFPC guidelines. At each point in time (D0, D1, D7, D15, D29, D60 and D90), visual aspect (limpidity), pH and osmolality were established. Clonidine concentration was quantified using a stability-indicating HPLC-UV-DAD method previously developed from a forced degradation study and validated according to SFSTP Pharma. Microbiological stability was also tested according to the European Pharmacopeia monograph with the best adapted method (by comparing membrane filtration and inclusion). Solutions were stored in amber glass bottles with an oral adapter for up to 3 months in two different conditions: 5 °C +/– 3 °C and at 25 °C +/– 2 °C with 60 % residual humidity (climatic chamber).ResultsThe formulated oral solution is composed of API at a concentration of 10 µg/mL and of potassium sorbate (0.3 %), citric acid, potassium citrate (pH 5 buffer) and sodium saccharine (0.025 %). Forced degradation highlighted six degradation products and the method was validated in the acceptance limits of ± 5 %. On D29, the mean percentages of the initial clonidine concentrations (+/–standard deviation) were 92.95+/–1.28 % in the solution stored at 25 °C +/– 2 °C and 97.44+/–1.21 % when stored at 5 °C +/– 3 °C. On D90, means were respectively 81.82+/–0.41 % and 93.66+/–0.71 %. The visual aspect did not change. Physical parameters remained stable during the study: pH varied from 4.94 to 5.09 and osmolality from 82 to 92 mOsm/kg in the two conditions tested here. Membrane filtration appeared to be the more sensitive method. Whatever the storage conditions,<1 micro-organism/mL was identified (only environmental) with no detectedE.coli.ConclusionsThis formulation is stable for at least 3 months at 5 °C +/– 3 °C in amber glass bottles and for one month when stored at room temperature. Microbiological stability was proven in accordance with the European Pharmacopeia.

scholarly journals Critical Aspects in the Preparation of Extemporaneous Flecainide Acetate Oral Solution for Paediatrics

Pharmaceutics ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 1963
Author(s):  
Antonella Casiraghi ◽  
Giorgio Centin ◽  
Francesca Selmin ◽  
Claudia Picozzi ◽  
Paola Minghetti ◽  
...  
Keyword(s):  
Sucrose Solution ◽  
Oral Solution ◽  
Citrate Buffer ◽  
Toxic Dose ◽  
Solubility Study ◽  
Time Period ◽  
Oral Liquid ◽  
Microbiological Stability ◽  
Flecainide Acetate ◽  
Microbiological Data

The availability of liquid oral preparations compounded by pharmacists is essential to meet paediatric needs which remain unanswered by the pharmaceutical industry. Unfortunately, compendial monographs are often not available and, in many cases, pre-formulation studies (e.g., compatibility with other excipients and solubility evaluations) are not performed in-depth, leading, in some rare cases, to the inadvertent administration of a toxic dose. In this study, the preparation of an oral liquid formulation for paediatric use, containing flecainide acetate at different strengths, was considered, taking into account the possible effects of conventionally used excipients. First, the optimal vehicle was selected based on a solubility study, evidencing some unexpected formations of precipitates. As a matter of fact, the buffers commonly used for oral solutions significantly reduced flecainide solubility, and the concomitant presence of citrate buffer and methylparaben even caused the formation of non-resuspendable crystals. Then, chemical, physical, and microbiological stability were assessed. Solutions at strengths of 10 and 20 mg/mL flecainide acetate were stable up to 8 weeks when compounded by using a 40% sucrose solution as a vehicle. Microbiological data showed that the use of methylparaben was not necessary over this time period.

Oral solution of levothyroxine vs tablets in subclinical hypothyroidism: evaluation of outcomes

2014 ◽  
Author(s):  
Renato Pastore ◽  
Daniela Mentuccia ◽  
Dorina Ylli ◽  
Giordani Ilaria ◽  
Frontoni Simona
Keyword(s):  
Subclinical Hypothyroidism ◽  
Oral Solution

POSTSURGICAL PAIN IN CHILDREN LESS THAN 2 YEARS OLD: FIRST EXPERIENCE WITH TAPENTADOL ORAL-SOLUTION

2018 ◽  
Author(s):  
Claudia Lefeber ◽  
Eva Tarau ◽  
Estelle Watson ◽  
Jiří Létal ◽  
Gregory Hammer
Keyword(s):  
Oral Solution ◽  
Postsurgical Pain

Design and stability of pediatric oral formulation of imatinib

2021 ◽  
pp. 107815522199120
Author(s):  
Mélanie Hinterlang ◽  
Amandine Gendron ◽  
Thomas Fleury ◽  
André Rieutord ◽  
Anastasia Vrana ◽  
...  
Keyword(s):  
High Performance ◽  
Protein Tyrosine Kinase ◽  
Pediatric Patients ◽  
Kinase Inhibitor ◽  
Philadelphia Chromosome ◽  
Oral Solution ◽  
Stability Study ◽  
Uv Detector ◽  
Stability Parameters ◽  
Tablet Dosage

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.

scholarly journals Investigation of the Physical, Chemical and Microbiological Stability of Losartan Potassium 5 mg/mL Extemporaneous Oral Liquid Suspension

Molecules ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 301
Author(s):  
Lisa Foley ◽  
Jennifer Toney ◽  
James W. Barlow ◽  
Maura O’Connor ◽  
Deirdre Fitzgerald-Hughes ◽  
...  
Keyword(s):  
Shelf Life ◽  
Storage Conditions ◽  
Losartan Potassium ◽  
Microbial Count ◽  
E Coli ◽  
Physical Chemical ◽  
Liquid Suspension ◽  
Oral Liquid ◽  
Microbiological Stability ◽  
Stability Data

Extemporaneous oral liquid preparations are commonly used when there is no commercially available dosage form for adjustable dosing. In most cases, there is a lack of stability data to allow for an accurately assigned shelf life and storage conditions to give greater confidence of product safety and efficacy over its shelf life. The aim of this study was to evaluate the physical, chemical and microbiological stability of an extemporaneous oral liquid suspension of losartan potassium, 5 mg/mL, used to treat paediatric hypertension in Our Lady’s Children’s Hospital Crumlin, Ireland. The losartan content of extemporaneous oral suspensions, prepared with and without addition of water, was measured by UV and confirmed by HPLC analysis. Suspensions were stored at 4 °C and room temperature (RT) and were monitored for changes in; pH, colour, odour, re-dispersibility, Total Aerobic Microbial Count, Total Yeast and Mould Count and absence of E. coli. Results showed that suspensions prepared by both methods, stored at 4 °C and RT, were physically and microbiologically stable over 28 days. Initial losartan content of all suspensions was lower than expected at 80–81% and did not change significantly over the 28 days. HPLC and NMR did not detect degradation of losartan in the samples. Suspensions prepared in water showed 100% losartan content. The reduced initial losartan content was confirmed by HPLC and was related to the acidic pH of the suspension vehicle. Physiochemical properties of the drug are important factors for consideration in the selection of suspension vehicle for extemporaneous compounding of oral suspensions as they can influence the quality, homogeneity and efficacy of these preparations.

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