Skip to main content
SpringerLink
Log in

Parenteral

  • Chapter
Practical Pharmaceutics

  • 8171 Accesses

Abstract

This chapter gives an overview of parenteral dosage forms and the rational for their use. Parenterals are sterile preparations that are injected intravascularly, administered into body tissues or into visceral cavities. The parenteral route of administration is often chosen for active substances that are poorly absorbed via the oral route or when rapid systemic availability and effects are required, or both. An introduction to the formulation and preparation of parenteral dosage forms is provided. Parenteral medicines can be formulated as solutions, emulsions or suspensions. Products, such as implants and microspheres are only briefly discussed. Knowledge about these types of products is a prerogative for the sound education of patients and caregivers in using the products.

Formulation strategies for reconstitution of ready to administer medicines are described in detail.

This chapter includes formulation considerations, preparation and quality control of parenteral nutrition. An overview of the administration methods of the parenteral dosage forms is also discussed

Based upon the chapter Parenteraal by Yvonne Bouwman-Boer and András Vermes in the 2009 edition of Recepteerkunde.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 109.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 139.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Voigt R (2006) Pharmazeutische Technologie, 10th edn. Deutscher Apotheker Verlag Stuttgart

    Google Scholar 

  2. American Society of Health-System Pharmacists (2013) ASHP guidelines: minimum standard for pharmacies in hospitals. Am J Health-Syst Pharm 70:1619–1630

    Article  Google Scholar 

  3. van der Linden P, Douchamps J, Schmitt C, Forget D (2002) Ready-to-use injection preparations versus conventional reconstituted admixtures: economic evaluation in a real-life setting. Pharmacoeconomics 20(8):529–536

    Article  PubMed  Google Scholar 

  4. EMA/CHMP development/QWP/799402/2011 (2012) Reflection paper on the pharmaceutical of intravenous medicinal products containing active substances solubilised in micellar systems

    Google Scholar 

  5. Schiettecatte S, Egot M, Marliot G, Sakji I, Cazin JL (2013) Securing intrathecal injections: What about non-luer connectors? Poster session presented at 18th congress of the European Association of Hospital Pharmacists, Paris, 13–15 Mar 2013

    Google Scholar 

  6. Imbelloni LE, Beato L, Gouveia MA, Cordeiro JA (2007) Low dose isobaric, hyperbaric, or hypobaric bupivacaine for unilateral spinal anesthesia. Rev Bras Anestesiol 57(3):261–270

    CAS  PubMed  Google Scholar 

  7. Nisbet AC (2006) Intramuscular gluteal injections in the increasingly obese population: retrospective study. BMJ 332(7542):637–638

    Article  PubMed  PubMed Central  Google Scholar 

  8. Maggio ET (2008) Novel excipients prevent aggregation in manufacturing and formulation of protein and peptide therapeutics. Bioprocess Int 6(10):58–65

    CAS  Google Scholar 

  9. Ward GH, Nolan PE Jr, Chawla M, Yalkowsky SH (1991) Studies in phlebitis: detection and quantitation using a thermographic camera. Pharm Res 8(1):76–79

    Article  CAS  PubMed  Google Scholar 

  10. Salgueiro-Oliveira A, Parreira P, Veiga P (2012) Incidence of phlebitis in patients with peripheral intravenous catheters: the influence of some risk factors. Aust J Adv Nurs 30(2):32–39

    Google Scholar 

  11. Szmuk P, Szmuk E, Ezri T (2005) Use of needle-free injection systems to alleviate needle phobia and pain at injection. Expert Rev Pharmacoecon Outcomes Res 5(4):467–477

    Article  PubMed  Google Scholar 

  12. Pérez Fidalgo JA, García Fabregat L, Cervantes A, Margulies A, Vidall C et al (2012) Management of chemotherapy& extravasation: ESMO- EONS clinical practice guidelines. Ann Oncol 23(Suppl 7):169–73

    Article  Google Scholar 

  13. Steffens KJ (1989) Parenterale Therapie und Fremdpartikeln 1. Mitt: Die Bedeutung partikulärer Verunreinigung bei der parenteralen Therapie. Pharm Ind 51:799–806

    Google Scholar 

  14. Kinine-injectie 600 mg = 5 ml (120 mg/ml) FNA. Jaar 2009. Formularium der Nederlandse Apothekers. Den Haag: Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie (KNMP)

    Google Scholar 

  15. Strickley RG (2004) Solubilizing excipients in oral and injectable formulations. Pharm Res 21(2):201–230

    Article  CAS  PubMed  Google Scholar 

  16. Robinson LA, Wright BT (1982) Central venous catheter occlusion caused by body-heat-mediated calcium phosphate precipitation. Am J Hosp Pharm 39(1):120–121

    CAS  PubMed  Google Scholar 

  17. Mottu F, Laurent A, Rüfenacht DA et al (2000) Organic solvents for pharmaceutical parenterals and embolic liquids: a review of toxicity data. PDA J Pharm Sci Techn 54(6):456–469

    CAS  Google Scholar 

  18. Lasic DD (1998) Novel applications of liposomes. TIBTCH 16:307–321

    Article  CAS  Google Scholar 

  19. Eroglu H, Alpar R, Öner L (2008) Chitosan in steroid delivery: formulation of microspheres by factorial design and evaluation of in-vitro release parameters. FABAD J Pharm Sci 33:144–150

    Google Scholar 

  20. Patel K, Forbes B, Cram M (2013) A study into upper and lower pH limits of intravenous products delivered by infusion. Poster session presented at Industrial Insight Symposium, Academy of Pharmaceutical Sciences conference, 4th-5th April Hertfordshire, UK

    Google Scholar 

  21. Bracher F, Heisig P, Langguth P, Mutschler E, Rücker G, Scriba G et al (2014) Arzneibuch-Kommentar: Dipyridamol, 47th edn. Wissenschaftliche Verlagsgesellschaft, Stuttgart

    Google Scholar 

  22. Stranz M (2002) Adjusting pH and osmolarity levels to fit standards and practices. The diverse and conflicting standards and practices in infusion therapy. J Vasc Access Devices (Fall) 12–19

    Google Scholar 

  23. Fysostigminesalicylaatinjectie 2 mg = 2 ml (1 mg/ml) FNA. Jaar 2009. Formularium der Nederlandse Apothekers. Den Haag: Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie (KNMP)

    Google Scholar 

  24. Huyghe I van, Nimme P van, Lammens G et al (2003) Antimicrobial preservatives in oily preparations. Pharmeuropa 15(2):266–270

    Google Scholar 

  25. EMA/CPMP/463/00 (2003) Guideline Excipients in the label and package leaflet of medicinal products for human use

    Google Scholar 

  26. Gibaldi M, Desai A, Lee M (2007) Gibaldi’s drug delivery systems in pharmaceutical care. American Society of Health-System Pharmacists, Bethesda, USA

    Google Scholar 

  27. Baheti A, Kumar L, Bansal AK (2010) Excipients used in lyophilisation of small molecules. J Excip Food Chem 1(1):41–54

    CAS  Google Scholar 

  28. Patel RM (2010) Parenteral suspension: an overview. Int J Curr Pharm Res 2(3):1–13

    Google Scholar 

  29. Karan M, Inderbir S, Manju N, Sandeep A (2010) Atrigel: a potential parenteral controlled drug delivery system. Der Pharmacia Sinica 1(1):74–81

    Google Scholar 

  30. Klemm K (2001) The use of antibiotic-containing bead chains in the treatment of chronic bone infections. Clin Microbiol Infect 7(1):28–31

    Article  CAS  PubMed  Google Scholar 

  31. Chapman AP (2002) PEGylated antibodies an antibody fragments for improved therapy: a review. Adv Drug Deliv Rev 54(4):531–545

    Article  CAS  PubMed  Google Scholar 

  32. Ciolli A, Leoni F, Bosi A (2006) The value of PegFilgastrim for the therapy of acute myeloid leukemia. Haematol Rep 2(7):96–98

    Google Scholar 

  33. Zhang R, Jain S, Rowland M, Hussain N, Agarwal M et al (2010) Development and testing of solid dose formulations containing polysialic acid insulin conjugate: next generation of long-acting insulin. J Diabetes Sci Technol 4(3):532–539

    Article  PubMed  PubMed Central  Google Scholar 

  34. Vu N (2009) Testing of electrolytes solutions. Int J Pharm Comp 13(1):53–5

    Google Scholar 

  35. EMA/809470/2013 (2013) Hydroxyethyl-starch solutions (HES) no longer to be used in patients with sepsis or burn injuries or in critically ill patients

    Google Scholar 

  36. Weinstein S (2007) Plumer’s principle & practice of intravenous therapy. Lippincott Williams & Wilkins, Philadelphia, USA

    Google Scholar 

  37. Bryland A, Broman M, Erixon M, Klarin B, Lindén T, Friberg H et al (2010) Infusion fluids contain harmful glucose degradation products. Intensive Care Med 36(7):1213–1220

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  38. Farquharson G (2012) Embracing rapid microbiological methods for products, processes and environments. Eur J Paren Pharm Sci 17(1):45

    Google Scholar 

  39. Shintani H (2013) Rapid assay of bioburden, endotoxin and other contamination. J Cromat Separat Techniq 4(8):2–7

    Google Scholar 

  40. Smeets OSNM, Le Brun PPH (2004) Zuurstof meten en verwijderen bij parenterale apotheekbereidingen. Meer stabiliteit door minder oxidatie. Pharm Weekbl 139(37):1207–1210

    Google Scholar 

  41. Veale J (2009) New inspection developments. In: Lysfjord J (ed) Practical aseptic processing, fill and finish, 1st edn. Davis Healthcare International Publishing, River Grove

    Google Scholar 

  42. Anonymous (2015) Pharmaceutical Dosage Forms. Injections. In: The United States Pharmacopeia 38 and the National Formulary 33. United States Pharmacopeial Convention, Rockville, USA

    Google Scholar 

  43. Morton Guazzo D (2010) Sterile product package integrity testing, current practice, common mistakes, new developments. Paper presented at PDA Metro Chapter Meeting, New Brunswick, 17 May 2010

    Google Scholar 

  44. Wolf H, Stauffer T, Chen S, Lee Y, Forster R, Ludzinski M et al (2009) Vacuum decay container/closure integrity testing technology. part 2. comparison to dye ingress tests. PDA J Pharm Sci Technol 63(5):489–98

    PubMed  Google Scholar 

  45. Kennedy L, Vaughan LM, Steed LL, Sahn SA (1995) Sterilisation of talc pleurodesis. Available techniques, efficacy, and cost analysis. Chest 107(4):1032–4

    Article  CAS  PubMed  Google Scholar 

  46. Knapp J (2005) The bridge between visible particle data and the accuracy and repeatability requirements of PAT, one safe step at a time. Paper presented at PDA visual inspection forum, Bethesda

    Google Scholar 

  47. Lier H, Kampe S, Schöder S (2007) Rahmenbedingungen für eine intakte Hämostase. Anaesthesist 56:239–251

    Article  CAS  PubMed  Google Scholar 

  48. Kenedy S (2011) Home infusion. Int J Pharm Comp 15(4):270–76

    Google Scholar 

  49. Herbig S, Kaiser V, Maurer J, Taylor L, Thiesen J, Krämer I (2013) ADKA-Leitlinie:Aseptische Herstellung und Prüfung applikationsfertiger Parenteralia. KHP 34(2):93–106

    Google Scholar 

  50. Richtlijn Voor Toediening Gereed Maken (VTGM) van parenteralia op verpleegafdelingen in ziekenhuizen. Versie 2.1, 5 Feb 2009. http://www.nvza.nl/www.nvza.nl

  51. Dominioni L, Rovera F, Pericelli A, Imperatori A (2003) The rationale of early enteral nutrition. Acta Biomed 74(Suppl 2):41–44

    PubMed  Google Scholar 

  52. Fusch C, Bauer K, Böhles HJ, Jochum F, Koletzko B, Krawinkel M et al (2009) Neonatology/paediatrics – guidelines on parenteral nutrition chapter 13. GMS 7:1–23

    Google Scholar 

  53. Puzovic M (2008) Lipid emulsions: alone or an all-in-one mixture. EJHP Pract 14(2):82–83

    Google Scholar 

  54. Janu M, Brodská H, Vecka M, Masteiková R, Kortlíková E, Lažauskas R et al (2011) Comparison of long-term stability of parenteral all-in-one admixtures containing new lipid emulsions prepared under hospital conditions. Medicina (Kaunas) 47(6):323–333

    Google Scholar 

  55. FDA Safety Alert. Hazards of precipitation associated with parenteral nutrition. 18 Apr 1994. http://www.fda.gov. Accessed 8 Nov 2014

  56. Pluhator-Murton MM, Fedorak RN, Audette RJ, Marriage BJ, Yatscoff RW, Gramlich LM (1999) Trace element contamination of total parenteral nutrition. 2. Effect of storage duration and temperature. J Parenter Enteral Nutr 23:228–232

    Article  CAS  Google Scholar 

  57. Steger P, Mühlebach S (2000) Lipid peroxidation of intravenous lipid emulsions and all-in-one admixtures in total parenteral nutrition bags: the influence of trace elements. J Parenter Enteral Nutr 24:37–41

    Article  CAS  Google Scholar 

  58. Schröder AM (2008) Total parenteral nutrition-problems in compatibility and stability. EJHP Pract 14(1):65–67

    Google Scholar 

  59. Anonymous (2012) <729> Globule size distribution in lipid injectable emulsions. In: The United States Pharmacopeia and the national formulary, 36th edn. United States Pharmacopeial Convention, Rockville

    Google Scholar 

  60. Allwood MC, Kearney MCJ (1998) Compatibility and stability of additives in parenteral nutrition admixtures. Nutrition 14(9):697–706

    Article  CAS  PubMed  Google Scholar 

  61. Henton DH, Merritt RJ (1990) Vitamin A sorption to polyvinyl and polyolefin intravenous tubing. J Parenter Enter Nutr 14(1):79–81

    Article  CAS  Google Scholar 

  62. Hoff DS, Michaelson AS (2009) Effects of light exposure on total parenteral nutrition and its implications in the neonatal population. J Pediatr Pharmacol Ther 14(3):132–143

    PubMed  PubMed Central  Google Scholar 

  63. American Society of Health-System Pharmacists (2000) ASHP guidelines on the safe use of automated compounding devices for the preparation of parenteral nutrition admixture. Am J Health-Syst Pharm 57:1343–1348

    Google Scholar 

  64. Koster VS, Kuks PFM, Lange R, Talsma H (1996) Particle size in parenteral fat emulsions; what are true limitations? Int J Pharm 134:235–238

    Article  CAS  Google Scholar 

  65. Driscoll DF (2005) Stability and compatibility assessment techniques for total parenteral nutrition admixtures: setting the bar according to pharmacopeial standards. Curr Opin Clin Nutr Metab Care 8:297–303

    Article  CAS  PubMed  Google Scholar 

  66. Driscoll DF (2006) Lipid injectable emulsions pharmacopeial and safety issues. Pharm Res 23:1959–1969

    Article  CAS  PubMed  Google Scholar 

  67. Driscoll DF, Silvestri AP, Bistrian BR, Mikrut BA (2007) Stability of total nutrient admixtures with lipid injectable emulsions in glass versus plastic packaging. Am J Heath-Syst Pharm 64:396–403

    Article  CAS  Google Scholar 

  68. Anonymous (2000) Evaluation, validation and implementation of new microbiological testing methods. PDA J Pharm Sci Technol 54(3) Suppl TR33:1–23

    Google Scholar 

  69. Timmer JG, Schipper HG (1991) Peripheral venous nutrition: the equal relevance of volume load and osmolarity in relation to phlebitis. Clin Nutr 10(2):71–75

    Article  CAS  PubMed  Google Scholar 

  70. Fuhrman MP (2009) Intradialytic parenteral nutrition and intraperitoneal nutrition. Nutr Clin Pract 24(4):470–80

    Article  PubMed  Google Scholar 

  71. ISO 594/1-1986. Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment

    Google Scholar 

  72. DIN EN 1707–1997. Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment-Lock fittings

    Google Scholar 

  73. WIP Richtlijn Ziekenhuizen Intravasale therapie 2006. www.wip.nl

  74. Boom FA (1991) In-line filtratie. Ziekenhuisfarmacie 7:46–48

    Google Scholar 

  75. Kommission für Krankenhaushygiene und Infektionsprävention beim Robert Koch-Institut (RKI) (2002) Prävention Gefäßkatheterassoziierter Infektionen. Bundesgesundheitsbl- Gesundheitsforsch- Gesundheitsschutz 45:907–924

    Google Scholar 

  76. The AccessAbility(tm) Programme HYPERLINK http://www.accessability-by-bard.co.uk/www.accessability-by-bard.co.uk

  77. Pittiruti M, Hamilton H, Biffi R, MacFie J, Pertkiewicz M (2009) ESPEN guidelines on parenteral nutrition: central venous catheters(access, care, diagnosis and therapy of complications). Clin Nutr 28(4):365–377

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Hospital pharmacy, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany

    Marija Tubic-Grozdanis & Irene Krämer

Authors
  1. Marija Tubic-Grozdanis
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Irene Krämer
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Marija Tubic-Grozdanis .

Editor information

Editors and Affiliations

  1. Laboratory of Dutch Pharmacists, Royal Dutch Pharmacists Association KNMP, The Hague, The Netherlands

    Yvonne Bouwman-Boer

  2. Former Quality Control Pharmacist to the Welsh Hospitals, Cardiff, United Kingdom

    V'Iain Fenton-May

  3. The Hague Hospital Pharmacy, The Hague, The Netherlands

    Paul Le Brun

Rights and permissions

Reprints and permissions

Copyright information

© 2015 KNMP and Springer International Publishing Switzerland

About this chapter

Cite this chapter

Tubic-Grozdanis, M., Krämer, I. (2015). Parenteral. In: Bouwman-Boer, Y., Fenton-May, V., Le Brun, P. (eds) Practical Pharmaceutics. Springer, Cham. https://doi.org/10.1007/978-3-319-15814-3_13

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-15814-3_13

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-15813-6

  • Online ISBN: 978-3-319-15814-3

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation