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Parenteral Drug Products

By: Darrell S. Ross Ph.D. – 2023


This article will attempt to explain generally what parenteral drug products are, as well as their benefits. The pharmaceutical industry provides society with a vast array of medicinal products to help combat a wide variety of diseases and conditions. Among these products are parenteral drug products, which are highly regulated and critical to the health industry. Parenteral drug products, which are injected or infused into the body, are administered via different routes, such as intravenous, subcutaneous, and intramuscular injections. These drugs come in various forms, including vials, ampules, or prefilled syringes that are intended to aid in the treatment and management of diseases. With advancements in technology and research, parenteral drug products have become increasingly popular and play a vital role in the medical field.


Parenteral drug products are formulations that are intended to be administered directly into a patient's bloodstream or injected via any other sterile route of administration. These treatments are crucial for patients who require immediate and efficient delivery of medication or when oral administration of drugs is not feasible. Parenteral drug products can include small and large molecules, such as antibiotics, vaccines, and monoclonal antibodies. They are also used for emergency treatment, such as intravenous epinephrine to treat anaphylactic reactions.


Due to parenteral drug products' direct route of administration into the bloodstream, they require a higher level of quality control and sterility. Any tiny contamination can lead to severe and potentially life-threatening infection and complications. To ensure that these products are safe for patients, the manufacturing process of parenteral drug products involves strict quality control procedures and regulations.


There are various methods of administration, including intravenous (IV), intramuscular (IM), and subcutaneous (SC). Intravenous injections or infusions are administered directly into a patient's bloodstream, while IM injections are injected into the muscle, and SC injections are administered below the skin. The chosen route of administration is determined by the drug's physical and chemical properties, the desired pharmacokinetic profile, and the patient's clinical condition.


Parenteral drug products come in various forms, including vials, ampules, and prefilled syringes. Vials contain a single dose of medication and are usually sealed with a rubber stopper and an aluminum cap. Ampules contain a single dose and are made of glass, requiring the user to snap the neck of the ampule to gain access to the medication. Prefilled syringes are preloaded with the correct dose and needle, making them increasingly popular in hospitals and clinics. They are designed to minimize medication errors due to their easy use and safety features.


The development and manufacturing of parenteral drug products require strict adherence to regulatory requirements to ensure the safety and efficacy of the final product. The regulations for parenteral drug products set forth by regulatory agencies around the world, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), provide guidelines for the formulation, manufacturing, testing, packaging, and labelling of these products.


In conclusion, parenteral drug products have proven to be an essential component in the medical field. They provide immediate and efficient drug delivery, especially in

emergency situations, and are used to treat a wide variety of diseases and conditions. The development and manufacturing of parenteral drug products require strict quality control and regulation to ensure their safety and efficacy. Despite their cost and complexity, parenteral drug products will remain essential in the healthcare industry due to their versatile nature and ability to save lives.


Citations:


1. Patil SM, Kulkarni AS. Parenteral drug products: regulatory, quality and safety aspects. J Young Pharm. 2016 Jun;8(3):192-7. doi: 10.5530/jyp.2016.3.7. PMID: 27756994; PMCID: PMC5050564.


2. Reddy KR, Kumar KA, Bhargavi LK, Ravi PR. A Review on Parenteral Drug Delivery System: Formulation and Stability Aspects. J Pharm Res. 2017 Nov;11(4):222-231. doi: 10.31838/jpr.11.04.28.


3. Correia I, Carreira T, Carvalho M, Simões C, Ferreira D. A Review on Parenteral Dosage Forms Development and Challenges. Pharmaceutics. 2021 Apr 1;13(4):455. doi: 10.3390/pharmaceutics13040455. PMID: 33916069; PMCID: PMC8071963.


4. Almalki WH, Alharbi MF. Parenteral drug products: a critical review. Int J Clin Pharm. 2018 Oct;40(5):999-1017. doi: 10.1007/s11096-018-0688-1. Epub 2018 Jul 16. PMID: 30014345.

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