DOI: https://doi.org/10.22263/2312-4156.2016.3.101
Hudz N.I.*, Korytniuk R.S.**
Aspects of risk identification in the technological process of dextrose-containing solutions for peritoneal dialysis
*Lvov National Medical University named after Danyla Galitsky, Lvov, Ukraine
**National Medical Academy of Post-Graduate Education named after P.L. Shupik, Kiev, Ukraine
Vestnik VGMU. 2016;15(3):101-109.
Abstract.
Objectives. To identify the risks associated with pH and the content of dextrose degradation products (DDP) in the technological process of the solutions for peritoneal dialysis (PD) containing dextrose on the basis of literature sources and our own experimental data obtained on the development of the composition and technology of laboratory batches of these solutions.
Material and methods. For the analysis of the literature sources the following methods were used: systematization, summarization and comparison of literature data. For the analysis of our own data physico-chemical, pharmaco-technological, analytical and biological methods were used. For the development of the composition and laboratory technology we investigated solutions containing (in mmol/l): sodium ions 92, 102, 112, 132; calcium ions 1,25; 1,75; magnesium ions 0,25; chloride ions 95, 100, lactate ions 0, 10, 20, 35, 40, 60. All these solutions contained 15, 25 or 42,5 (44,0) g/l glucose monohydrate.
Results. Various risks may arise in the technological process of peritoneal dialysis solutions depending on the medium reaction, dextrose and sodium lactate concentration, method of sterilization and other factors. These risks are associated with the regime of heat sterilization, storage and transportation temperature, sterilizing filtration conditions. One of the main consequences of these risks is the increased quantity of dextrose degradation products in the solutions for PD, that which may be the cause of chemical peritonitis. The main consequence of the risks of sterilizing filtration of solutions for PD may be nonsterile samples.
Conclusions. It is very important to maximally explore the possible sources of risks, to identify and describe the risks, to indicate their possible causes and consequences at the stage of the pharmaceutical development of composition and technology of laboratory batches of solutions for peritoneal dialysis.
Key words: manufacturing risks, solutions for peritoneal dialysis, dextrose degradation products.
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Information about authors:
Hudz N.I. – Candidate of Pharmaceutical Sciences, associate professor of the Chair of Drug Technology & Biopharmacy of Lvov National Medical University named after Danyla Galitsky, Ukraine;
Korytniuk R.S. – Doctor of Pharmaceutical Sciences, professor of the Chair of Pharmaceutical Technology & Biopharmacy of National Medical Academy of Post-Graduate Education named after P.L. Shupik, Ukraine.
Correspondence address: Ukraine, 79010, Lvov, 75 Pekarskaya str., Lvov National Medical University named after Danyla Galitsky, Chair of Drug Technology & Biopharmacy. Phone: +38 (032) 276-85-84. E-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра. –
Hudz N.I.
