scholarly journals Stability and Compatibility of Drug Mixtures from Intrathecal Pump Using High Performance Liquid Chromatography

2020 ◽  
pp. 15-21
Author(s):  
Saba Javed

Although management of intractable pain using long-term intrathecal analgesic administration by implantable infusion systems has become acceptable clinical practice, this method presents unique challenges regarding the stability of the pharmaceutical agent(s) delivered. The stability and compatibility of a single drug such as hydromorphone or bupivacaine, as well as mixtures of morphine-clonidine, have previously been reported, but only using implantable infusion systems and syringes under simulated clinical use conditions, not from implanted intrathecal pumps. The objective of this study was to assess the compatibility and stability of drug mixtures from intrathecal pumps placed in patients. For this case-series, 5 patients with intrathecal pumps who presented to the pain clinic for refill were randomly selected. An aliquot of sample extracted from the pump and an aliquot of new medicine used for pump refill were collected. High performance liquid chromatography (HPLC) was used to compare the 2 samples. Drug samples used were as follows: (A) hydromorphone only, (B) morphine and bupivacaine, (C) hydromorphone and ziconotide, (D) ziconotide and baclofen; and (E) hydromorphone, ziconotide, and baclofen. Samples B and E appeared to be stable when placed in situ in the SynchroMed II intrathecal pump based on the HPLC analysis. However, samples A, C, and D appeared to have undergone some degradation and/or byproduct formation as noted in the graphical display on HPLC. While sample A was a single-drug combination, the sample was in the pump for over 3 months; likewise, sample E was a 3-drug combination, however it was in the pump for only 30 days. Based on these results, it appears as though (a) when the length of time the drug stays in the intrathecal pump increases, or (b) when a combination of drugs is used in the intrathecal pump (as opposed to a single drug), some drug degradation and/or byproduct formation happens as seen on HPLC. This is the first reported study assessing the compatibility and stability of drug mixtures from intrathecal pumps. While the above reported HPLC data reveals quantitative differences, further qualitative analysis is required for confirmation and possible identification of possible degradation and/or byproducts. Key words: Degradation, high performance liquid chromatography, intrathecal pump

1992 ◽  
Vol 262 (2) ◽  
pp. G351-G358
Author(s):  
R. Zhang ◽  
S. Barnes ◽  
R. B. Diasio

Mechanisms responsible for the difference in the relative amounts of taurine- and glycine-conjugated bile acid N-acyl amidates (Tau/Gly ratio) are not fully understood. In the present study, the stability of taurine- and glycine-conjugated bile acid N-acyl amidates during intestinal transit and absorption was examined to investigate the contribution of intestinal deconjugation to the Tau/Gly ratio in rat bile. Radiolabeled chenodeoxycholic acid (CDC) and its N-acyl amidates with glycine (CDC-Gly) or taurine (CDC-Tau) were introduced into the lumen of the upper small intestine in the biliary fistula rats, and radioactive metabolites in bile, blood, urine, and tissues were identified and quantitated by high-performance liquid chromatography. Results indicated that 1) extensive deconjugation of CDC-Gly occurs during intestinal absorption; 2) CDC-Tau is recovered in bile largely intact; and 3) newly synthesized CDC-Tau and CDC-Gly are formed in a ratio of less than 2:1 after administration of [14C]-CDC. In summary, the present study demonstrates that resistance of taurine-conjugated bile acid N-acyl amidates to hydrolysis in the intestine, rather than a difference in synthesis of taurine- and glycine-conjugated N-acyl amidates in liver, may account for the high Tau/Gly ratio in rat bile.


2016 ◽  
Vol 47 (4) ◽  
Author(s):  
Jebur & et al.

This study was aimed to know the efficiency of partially purified L- asparaginase produced from local isolate from Erwinia spp. to reduce the percentage of acrylamide formed in Biscuit. Four types of biscuit from wheat flour were prepared (T1, T2, T3, T4),and T1 as control. High performance liquid chromatography technique was used to estimate acrylamide ratio in biscuit , Effect of enzyme addition  on flour chemical and rheological properties was studied, also dough behavior ,gluten percentage, water absorption and amylase enzyme activity was estimated. The results revealed  that  the  addition of  experimental asparaginase ( specific activity 20.5 unite mg-1 ) with 1% of flour weight lead to reduce in acrylamide formation in Biscuit  to 89 %  compared  to  control sample ( in absence of enzyme ) . Moreover, the addition of Asparagine to flour at 0.1 % of its weight, where L- asparaginase was available caused a negative effect on enzyme efficiency in reducing the acrylamide in biscuit. So the level of acrylamide was reduced to 57.7 %. In the other hand , the percentage of acryl amide in biscuit was increased to   233 % when the asparagine was added to mixture in absence of L- asparaginase .Addition of  the enzyme to flour have no effect on the percentage value of gluten but improved the  stability of dough .The  enzyme  addition also led to increase amylases activities.  Addition of experimental enzyme had no effect on quality and sensory evaluation of biscuit.


2016 ◽  
Vol 13 (26) ◽  
pp. 78-87
Author(s):  
Tiago Hickman IGLIN ◽  
Flávia Nathiely Silveira FACHEL ◽  
Amanda Gonçalves GUWZINSKI ◽  
Airton Monza da SILVEIRA ◽  
Filipe de Medeiros ALBANO ◽  
...  

Amoxicillin, substance-related to semisynthetic penicillin, has been widely used to treat infections caused by various microorganisms, however reports of suitable methods for the quantitative determination and indicative of the stability of formulations containing this substance are rare. Due to lack of studies on the forced degradation of the substance and on the need to monitor the quality of this type of formulation was proposed and validated a method for the determination of amoxicillin content in capsules by high-performance liquid chromatography - HPLC for the quality control of amoxicillin capsules, allowing the provision of useful information about the characteristics of this type of formulation and its stability. The method was validated for parameters of linearity, specificity, accuracy, precision, and robustness


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