citrate buffer range

citrate buffer range

PubMed Central  The present review is based on literature search using Pubmed, MEDLINE, Google, and Google Scholar databases. Although it was observed, in both studies, that the thigh injection was more painful than the injection in the abdomen, the sensation of pain did not change for injected volumes in the range of 0–0.8 ml, neither in the thigh nor in the abdomen. Pediatr Diabetes. Hirsch L, Gibney M, Berube J, Manocchio J. Somatosens Mot Res. controvertial since the pKa3 value may be 5.40, as However, the 10th Edition, Martha Windholz, ed.). Jones LS, Kaufmann A, Middaugh CR. Sci Rep. 2017;7(1):9613. Bolge SC, Goren A, Tandon N. Reasons for discontinuation of subcutaneous biologic therapy in the treatment of rheumatoid arthritis: a patient perspective. 2018. https://s3-us-west-2.amazonaws.com/drugbank/fda_labels/DB00051.pdf?1543522358. 0000004797 00000 n Injection speed seems to have no impact on injection-related pain [25, 26, 35]. A very low viscosity of the injected solution has also been associated with an increased sensation of pain. A review by Meyer et al. Food and Drug Administration. Guo X, Wang W. Challenges and recent advances in the subcutaneous delivery of insulin. Horm Res. Citrate-Phosphate Buffer; pH range 2.6 to 7.0. Only articles written in English were included and the keywords employed were “pain” and “subcutaneous” combined with “needle length”, “needle diameter”, “injection site”, “injection procedure”, “injection volume”, “injection speed”, “osmolality”, “viscosity”, “buffer”, or “preservative”. This article is based on previously conducted studies and does not contain any studies with human participants or animals performed by any of the authors. 0000016698 00000 n However, some studies have shown that citrate concentrations lower than 50 mM may also be painful. Nowadays, new non-injectable subcutaneous systems and technologies are being developed, ensuring virtually painless and highly efficient drug delivery. Nash P, Vanhoof J, Hall S, et al. 2004;62(Suppl 3):98–103. 2015. https://www.adea.com.au/wp-content/uploads/2015/11/Injection-Technique-Final-digital-version2.pdf. Development of biopharmaceutical parenteral dosage forms. J Pharm Sci. Expert Opin Drug Deliv. Adv Ther 36, 2986–2996 (2019). Accessed Nov 2018. also shows the titration curve of 20 mM 2-[N- 2015;8:473–84. 2016;105(8):2255–9. 0000026328 00000 n 2014;9(1):e86637. Heise T, Nosek L, Dellweg S, et al. In: Bontempo JA, editor. Pharm Technol. Wang W. Tolerability of hypertonic injectables. Cooper K, Gosnell K. Foundations of nursing. To view enhanced digital features for this article go to https://doi.org/10.6084/m9.figshare.9861800. Article  1). J Pharm Sci. CAS  2009;24(4):241–3. The appropriateness of the length of insulin needles based on determination of skin and subcutaneous fat thickness in the abdomen and upper arm in patients with type 2 diabetes. A total of 188 articles were identified and reviewed, and both their text and references were analyzed. are 3.13, 4.76 and 6.40, as shown in The Merck Index (pp 330-331, 0000020934 00000 n Large subcutaneous injection volumes are associated with pain. Gely C, Marin L, Gordillo J, et al. PubMed  The most relevant articles were used to write this review. Although in vitro methods, based on subcutaneous and muscle tissues of porcine, have been developed to evaluate the effect of injection conditions on the drug permeation in tissues [6], their use to predict sensation of pain in patients is limited because of the absence of functional sensory nerves. St. Louis: Elsevier; 2019. 2014;38(2):120–33. 2006;98(2):218–21. Article  Notwithstanding the aforesaid advantages of the SC route, patients’ adherence to treatments based on SC injections can be compromised by the frequency of injections and injection site reactions, including pain, mainly when the consequence of nonadherence is not immediately life-threatening [3]. Furthermore, citric acid does not seem to be a good buffer even considering pKa values ranging from 3.1 to 5.4 (Fig. Muscle is more vascularized than SC tissue and the absorption of drugs is faster after an IM injection, which leads to modified response as compared to that obtained after SC injection. Impact of pain due to subcutaneous administration of a biological drug. 1993;22(4):553–6. PubMed  Formulation development. Prepare immediately before use. A recent report from the UK National Health Service (NHS) based on 6 months’ usage of adalimumab biosimilars in 35,000 patients in the UK (63.6% of patients that were receiving adalimumab) has analyzed the reported discomfort at the injection site. Injected volumes of up to 0.5–0.8 ml are not expected to increase substantially the pain produced by the needle insertion. 2) is another factor commonly associated with the sensation of pain, with less frequent painful needle insertions in the case of needles with smaller diameters [16]. 0000015789 00000 n Mathaes R, Koulov A, Joerg S, Mahler HC. 0000000016 00000 n The use of citrate to buffer adalimumab solutions has also been related to a higher sensation of pain [41, 42], although given the design of some of these studies it is difficult to attribute the differences in the injection site-related pain to the content in citrate buffer. 0000016080 00000 n Google Scholar. Comparison of two needle sizes for subcutaneous administration of enoxaparin: effects on size of hematomas and pain on injection. The titration curve for sodium Besides a direct effect of the drug itself, several factors may be associated with the sensation of pain after SC injections: needle features, injection technique and site, volume injected, injection speed, osmolality, viscosity and pH of formulation, as well as the kind of excipients in the formulation, including buffers and preservatives. Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for insulin injections: implications for needle length recommendations. José-Esteban Peris has acted as a consultant for Sandoz, Qualicaps Europe, Schering-Plough, Dupont Pharma and Belmac Laboratories. Am J Kidney Dis. J Pharm Pharmacol. Buffers (Table 2) are added to parenteral formulations to adjust the pH [33, 36, 37] with the aim of optimizing solubility and stability, and are typically used in the 10–100 mM range [33]. Poulos C, Kinter E, Yang JC, Bridges JF, Posner J, Reder AT. Fransson J, Espander-Jansson A. Phosphate/citrate buffer. In fact, in a study comparing the pain perceived after the injections of three different fluid viscosities (1, 8–10, and 15–20 cP) it was observed that high viscosity injections (up to 15–20 cP) were less painful and, consequently, the most easily tolerated ones [32]. 2016;50(1):7–9. They have several advantages such as that are easy to use, store, and dispose, and do not require any expert supervision or handling. 2017;14(6):727–34. pH range of 2.5 to 7.0 since the pKa values for this triprotic acid 0000009346 00000 n Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn’s disease: the CLASSIC-I trial.

Concentration Gradient Diffusion, Trader Joe's Vegetable Lasagna Review, Limited Partnership Vs General Partnership, Wipeout Games On Pc, Trader Joe's $250 Coupon, Saudi Moon Sighting Today, Dr Formulated Probiotics Once Daily, Sahaj Name Meaning In Punjabi, Prime Slime Secret Lair Artist, Language And Human Connection,