Compatibility of diazepam with polypropylene multilayer infusion container

Noh, Dong Il; Park, Kyu Nam; Chun, Heung Jae; Park, Chong Won; Jang, Ju Woong; Ahn, Yun Gyong

doi:10.1007/bf03218900

Cited by 6 publications

(4 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…For DZP raw material, the characteristic band at 1681 cm −1 can be attributed to the imine groups (C=N), while the one at 1600 cm −1 to the conjugated alkene (C=C). This spectrum is similar to the one observed in previous work [ 30 , 31 ]. PVA spectra present a large band in the range of 3550–3000 cm −1 attributed to the O–H from the intermolecular and intramolecular hydrogen bonds and a band at 1141 cm −1 due to the C–O groups.…”

Section: Resultssupporting

confidence: 91%

Production of Bi-Compartmental Tablets by FDM 3D Printing for the Withdrawal of Diazepam

et al. 2023

View full text Add to dashboard Cite

Diazepam (DZP) is a long-acting benzodiazepine to treat anxiety or acute alcohol withdrawal. Although this class of drugs should be taken for a short period of time, many patients take them for longer than recommended, which has been linked to an increased risk of dementia and dependence. The present work aimed at using the dual-nozzle system of fused deposition modeling (FDM) 3D printers to prepare tablets with gradual doses of DZP with constant mass and size. Placebo and DZP-loaded filaments were prepared by hot-melt extrusion and used to print the bi-compartmental tablets. Thermal processing allowed the conversion of crystalline DZP to its amorphous counterpart. Tablets with different DZP contents were effectively printed with a mass, thickness and diameter average of 111.6 mg, 3.1 mm, and 6.4 mm, respectively. Microscopic data showed good adhesion between the different layers in the printed tablets. The desired drug contents were successfully achieved and were within the acceptance criteria (European Pharmacopeia). The combination of a placebo and drug-loaded extrudates proved to be beneficial in the production of tablets by FDM for patients in need of drug withdrawal.

show abstract

Section: Resultssupporting

confidence: 91%

Production of Bi-Compartmental Tablets by FDM 3D Printing for the Withdrawal of Diazepam

et al. 2023

View full text Add to dashboard Cite

show abstract

“…The 0.9% NaCl and Hartmann's solution fluid bags used in this study were manufactured from polyvinylchloride, which has previously been shown to adsorb certain drugs when compared to a polypropylene delivery system (Noh et al . 2009), and this is one possible explanation for the higher degree of apparent degradation of lidocaine in our study compared to that of Beiler et al . (2020).…”

Section: Discussionsupporting

confidence: 53%

“…The extent of lidocaine degradation was also similar between those fluid bags stored at room temperature or in a refrigerator, suggesting that the reduction in concentration over time was not associated with temperature. The 0.9% NaCl and Hartmann's solution fluid bags used in this study were manufactured from polyvinylchloride, which has previously been shown to adsorb certain drugs when compared to a polypropylene delivery system (Noh et al 2009), and this is one possible explanation for the higher degree of apparent degradation of lidocaine in our study compared to that of Beiler et al (2020). Although the lidocaine appeared to decrease more rapidly and to a greater extent than either methadone or ketamine in the MLK solutions, there was no statistical difference between the rate of degradation of the three drugs, with all decreasing over time, with the exception of the methadone in MLK diluted in Hartmann's solution at 4°C.…”

Section: Discussionmentioning

confidence: 99%

Stability of dilutions of methadone alone, and in combination with lidocaine and ketamine

Gomez

Al‐Tannak

Auckburally

et al. 2022

J of Small Animal Practice

View full text Add to dashboard Cite

To assess stability and degradation over time, of methadone alone, and mixed with lidocaine and ketamine, using various diluents and storage conditions.Materials and MethOds: Solutions of methadone diluted in 0.9% NaCl, and methadone-lidocaineketamine diluted in 0.9% NaCl or Hartmann's solution, and stored at room temperature with exposure to light, or refrigerated at 4°C and protected from light, were maintained over 10 days. Chemical stability was determined using liquid chromatography immediately after preparation and following 4, 24, 48, 96 and 240 hours of storage. Physical stability of the solutions was evaluated by visual examination and absorbance of ultraviolet/visible light. A linear model assessed the impact of different diluent solutions and storage conditions on drug degradation over time.results: There was no evidence of physicochemical incompatibility for any solution. Methadone concentration, when diluted alone or in methadone-lidocaine-ketamine with Hartmann's solution at 4°C, did not decline over time. Ketamine and lidocaine decreased to a similar extent over time, regardless of the diluent used or storage method, while methadone in methadone-lidocaine-ketamine diluted with 0.9% NaCl or with Hartmann's solution at room temperature exposed to light, also declined over time; however, all three methadone-lidocaine-ketamine components retained acceptable stability (<10% degradation) for at least 48 hours following preparation, irrespective of diluent or storage conditions. clinical significance: Regardless of the diluent or storage method, methadone-lidocaine-ketamine solutions degrade over time, but this only becomes clinically significant after 48 hours. Solutions of 1 mg/ml methadone in 0.9% NaCl are stable for at least 10 days under storage conditions likely to be encountered in general practice.

show abstract

“…In 2009, Treleano et al described that the nature of plasticizers was also relevant in the diazepam-PVC interaction [ 13 ]. Noh et al also proposed a new polypropylene multilayer container (Techflex ® ) as an appropriate primary packing container for diazepam [ 14 ]. In 2016, Jin et al proposed polyolefin tubes for diazepam infusion as a better option than polyurethane and PVC tubes [ 15 ].…”

Section: Introductionmentioning

confidence: 99%

Effect of Primary Packaging Material on the Stability Characteristics of Diazepam and Midazolam Parenteral Formulations

Fernández¹,

Serrano

Torrado

2022

Pharmaceutics

View full text Add to dashboard Cite

Diazepam and midazolam are formulated in autoinjectors for parenteral administration to decrease seizures in the case of emergency. However, the compatibility of these lipophilic drugs with the primary packaging material is a key part of drug formulation development. In this work, diazepam and midazolam were packaged in glass syringes as parenteral solutions using two different elastomeric sealing materials (PH 701/50 C BLACK and 4023/50 GRAY). Syringes were stored at three different storage temperatures: 4, 25, and 40 °C. At different time points over 3 years, physical appearance, benzodiazepine sorption on the sealing elastomeric materials, and drug content in solution were assayed. A detailed study on the adsorption profile of both benzodiazepines on the elastomeric gaskets was performed, indicating that the novel rubber material made of bromobutyl derivatives (4023/50 GRAY) is a better choice for manufacturing autoinjectors due to lower drug adsorption. Diazepam showed a better stability profile than midazolam, with the latter solubilised as a hydrochloride salt in an acidic pH that can affect the integrity of the elastomer over time. The amount of drug adsorbed on the surface of the elastomer was measured by NIR and correlated using chemometric models with the amount retained in the elastomeric gaskets quantified by HPLC.

show abstract

Compatibility of diazepam with polypropylene multilayer infusion container

Cited by 6 publications

References 16 publications

Production of Bi-Compartmental Tablets by FDM 3D Printing for the Withdrawal of Diazepam

Production of Bi-Compartmental Tablets by FDM 3D Printing for the Withdrawal of Diazepam

Stability of dilutions of methadone alone, and in combination with lidocaine and ketamine

Effect of Primary Packaging Material on the Stability Characteristics of Diazepam and Midazolam Parenteral Formulations

Contact Info

Product

Resources

About