Physicochemical and microbiological stability studies of extemporaneous antihypertensive pediatric suspensions for hospital use.

08:37 EDT 31st March 2015 | BioPortfolio

Summary of "Physicochemical and microbiological stability studies of extemporaneous antihypertensive pediatric suspensions for hospital use."

Extemporaneous suspensions of the antihypertensive agents furosemide, spironolactone and hydrochlorothiazide for pediatric use have been prepared at University Hospital (Federal University of Santa Catarina - Brazil). The aim of this work was to investigate the physicochemical and microbiological stability of these suspensions over the estimated shelf-life period of seven days and, if necessary, to optimize the formulations by improving the chemical stability. The pediatric suspensions were prepared using drug raw material and were stored at 25 ± 2°C and 5 ± 3°C. Chemical stability was evaluated by HPLC assay of the suspensions for drug content. Physical stability was evaluated by sedimentation volume, redispersibility, particle size, and zeta potential. Viable bacterial and fungal contaminations were assessed according to the official compendium. Furosemide and spironolactone suspensions as prepared herein can be stored for 7 days. However, the hydrochlorothiazide suspension formulation at pH 6.5 demonstrated poor chemical stability and was optimized by adjusting the pH to 3.3 where the drug exhibited acceptable stability. The optimized formulation demonstrated to be stable over the required period of 7 days.


Department of Pharmaceutical Sciences, Health Science Centre, Federal University of Santa Catarina , Quality Control Laboratory, Florianópolis-SC , Brazil.

Journal Details

This article was published in the following journal.

Name: Pharmaceutical development and technology
ISSN: 1097-9867


PubMed Articles [18576 Associated PubMed Articles listed on BioPortfolio]

The physicochemical and microbiological characteristics of saliva during and after pregnancy.

Objectives Identify the changes in some physiological and microbiological parameters in the saliva from a group of women during and after their pregnancies. Methods Stimulated whole saliva was collect...

Use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and valsartan.

Abstract Available tablets or capsules for adults are often used to prepare extemporaneously formulated medicines appropriate for children. The most acceptable drug forms in pediatric population are o...

-Study of quality and stability of ursodeoxycholic acid formulations for oral pediatric administration.

This paper describes a rational method of characterizing the biopharmaceutical stability of two oral suspensions of ursodeoxycholic acid (UDCA) used in pediatrics. Because there is no commercial prese...

Culture medium-associated physicochemical insights on cytotoxicity of carbon nanomaterials.

Carbon nanomaterials are the most studied materials in nanotechnology. There have been numerous studies on cytotoxicity assessments of carbon nanomaterials, which however often lead to controversy. It...

Quality evaluation of the Finasteride polymorphic forms I and II in capsules.

Finasteride (FNS) is a specific competitive inhibitor of steroid type-II 5α-reductase and is widely used for the treatment of benign prostatic hyperplasia, prostate cancer, and androgenetic alopecia....

Clinical Trials [1954 Associated Clinical Trials listed on BioPortfolio]

Intra-individual Stability in Electroencephalography (EEG) Parameters

The main objective is to evaluate the stability of EEG features on an individual level.

Effect of Fenofibrate on Endothelial Function and High-density Lipoproteins (HDL) Physicochemical and Functional Characteristics in Patients With Coronary Heart Disease

Fenofibrate is a drug that acts on the PPAR alpha receptors, increasing HDL-cholesterol and decreasing triglyceride levels. The interaction with these receptors has antiatherogenic actions...

Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide

Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2). However, no clinical studies have investigated its microbiological efficacie...

TMC114-TiDP29-C232 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Children Coming From Any of the Three Ongoing Tibotec Sponsored Pediatric Studies With DRV

The primary objective of this study is to continue to provide Darunavir (DRV) to pediatric patients who previously received DRV in any of three pediatric clinical studies sponsored by Tibo...

Gait Stability of People With Lower-Limb Amputations

The purpose of this study is to evaluate whether there are quantifiable differences in walking stability, as measured by the acceleration of the trunk or the variation in step length, betw...

Medical and Biotech [MESH] Definitions

Colloids with liquid continuous phase and solid dispersed phase; the term is used loosely also for solid-in-gas (AEROSOLS) and other colloidal systems; water-insoluble drugs may be given as suspensions.

Studies designed to examine associations, commonly, hypothesized causal relations. They are usually concerned with identifying or measuring the effects of risk factors or exposures. The common types of analytic study are CASE-CONTROL STUDIES; COHORT STUDIES; and CROSS-SECTIONAL STUDIES.

Sequences within RNA that regulate the processing, stability (RNA STABILITY) or translation (TRANSLATION, GENETIC) of RNA.

Studies in which the presence or absence of disease or other health-related variables are determined in each member of the study population or in a representative sample at one particular time. This contrasts with LONGITUDINAL STUDIES which are followed over a period of time.

Physical reactions involved in the formation of or changes in the structure of atoms and molecules and their interactions.

Search BioPortfolio:

Relevant Topic

Latest News Clinical Trials Research Drugs Reports Corporate
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Article