Parenterals are the drug products that are sterile and administrated directly into patients, and include high-value and life-relevant products such as anti-cancer drugs. The manufacturing process typically comprises compounding of the drug substance, sterile filtration, and filling of drug solution into containers such as vials or syringes.
What does parenteral mean medically?
Thus, parenteral in medicine means the input of drugs or medications into the human body in a way not involving the intestines or the digestive tract. Parenteral drugs are typically injected directly into the human body and have a systemic, wide effect on the body.
What does the term parenteral mean?
Updated: 07/28/2021 The term parenteral in medical terminology means beyond the intestine (par = beyond, enteral = intestines). Thus, parenteral in medicine means the input of drugs or medications into the human body in a way not involving the intestines or the digestive tract.
What kind of patients need parenteral nutrition?
You may need parenteral nutrition for one of the following reasons:
- Cancer. Cancer of the digestive tract may cause an obstruction of the bowels, preventing adequate food intake. ...
- Crohn's disease. ...
- Short bowel syndrome. ...
- Ischemic bowel disease. ...
- Abnormal bowel function. ...
What does parenteral mean in medical dictionary?
Parenteral Definition. The term parenteral in medical terminology means beyond the intestine (par = beyond, enteral = intestines). Thus, parenteral in medicine means the input of drugs or ...
What do you mean by parenterals?
adjective. par·en·ter·al pə-ˈrent-ə-rəl. : situated or occurring outside the intestine. parenteral drug administration by intravenous, intramuscular, or subcutaneous injection. especially : introduced otherwise than by way of the intestines.
What is parenteral and examples?
Relating to or describing the method or route of administration not through the gastrointestinal tract but through other route, such as subcutaneous, intravenous, intramuscular, etc. For instance, parenteral nutrition pertains to the administration of nutrition through the veins.
What are parenterals give their types?
Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants. They are sterile preparations intended to be administrated directly into the systemic circulation in human or animal body.
What are the parenteral drugs?
Parenteral drug administration refers to drugs given by routes other than the digestive tract. The term parenteral is usually used for drugs given by injection or infusion.
Why is it called parenteral?
Parenteral drug administration means any non-oral means of administration, but is generally interpreted as relating to injecting directly into the body, bypassing the skin and mucous membranes.
What are the 4 common parenteral route?
Administration by injection (parenteral administration) includes the following routes: Subcutaneous (under the skin) Intramuscular (in a muscle) Intravenous (in a vein)
What are 3 forms of parenteral administration?
Parenteral routes of administration include the subcutaneous, intramuscular, and intravenous routes.
What are requirements of parenterals?
Parenteral products are unique from any other type of pharmaceutical dosage form for the following reasons: • All products must be sterile. All products must be free from pyrogenic (endotoxin) contamination. Injectable solutions must be free from visible particulate matter. This includes reconstituted sterile powders.
What is parenteral and non parenteral?
Drugs might be administered parenteral (intravenous or intramuscular) or non- parenteral including oral, rectal, sublingual, aerosolized buccal and intranasal.
What are the 5 parenteral routes?
There are five commonly used routes of parenteral (route other than digestive tract) administration: subcutaneous (SC/SQ), intraperitoneal (IP), intravenous (IV), intrader- mal (ID), and intramuscular (IM).
What are the 3 types of injections?
The three main routes are intradermal (ID) injection, subcutaneous (SC) injection and intramuscular (IM) injection. Each type targets a different skin layer: Subcutaneous injections are administered in the fat layer, underneath the skin. Intramuscular injections are delivered into the muscle.
What is the difference between parenteral and injection?
Parenteral medications enter the body by injection through the tissue and circulatory system. Injection medications are absorbed more quickly and are used with patients who are nauseated, vomiting, restricted from taking oral fluids, or unable to swallow.
What are examples of parenteral administration?
Administration by injection (parenteral administration) includes the following routes:Subcutaneous (under the skin)Intramuscular (in a muscle)Intravenous (in a vein)Intrathecal (around the spinal cord)
What is an example of parenteral nutrition?
Parenteral nutrition provides liquid nutrients, including carbohydrates, proteins, fats, vitamins, minerals and electrolytes. Some people use parenteral nutrition to supplement feeding through a tube placed into the stomach or small bowel (enteral nutrition), and others use it by itself.
What is an example of parenteral transmission?
Parenteral Exposure – Parenteral exposure is when infected blood and/or bodily fluids are introduced into the body through piercing or puncturing the skin. An example would be getting stuck with a contaminated needle or being cut with a sharp object that's been contaminated.
What are the 5 parenteral routes?
techniques of parenteral drug administration include IM, IN, transdermal, submucosal, subcutaneous (SC), IV, intraspinal, and intracapsular injections.
What Is Parenteral?
Our exposure to needles comes early in life. From the multiple shots you receive as a baby to the IV fluids you might receive in an ambulance, the use of needles to put medicine, blood, or fluids into a patient is commonplace in the world of health care.
What is the fastest parenteral route?
The most common routes of parenteral drug administration are: Intravenous (IV) - an injection into a vein. Intraosseous infusion - an injection into the bone marrow (this is the fastest parenteral route) Subcutaneous (subQ) - an injection into the layer of tissue beneath the skin (such as insulin)
What are the different types of parenteral routes?
Types of Parenteral Routes. The most common parenteral routes of drug administration are intravenous, intraosseous, intramuscular, subcutaneous, epidural, and intradermal. Let's take a closer look at each. Medicines or fluids that go directly into the patient's vein are being given by the intravenous (IV) route.
What is intradermal injection?
That kind of injection is called an intradermal injection, which puts medicine into the skin. Although there are many others, we have covered the most common parenteral routes. Lesson Summary. Parenteral refers to medication administered in a manner other than the digestive system.
What is the name of the IV for a patient whose digestive system is not digesting nutrients?
For patient's whose digestive system will not digest or absorb nutrients properly, we give them all the nutrients they need through a special kind of IV called TPN, or total parenteral nutrition . TPN is personalized to the patient's condition and requires frequent blood tests to see if the recipe needs to be changed.
What is the name of the tube that is inserted into the heart?
Most IV lines are flexible, plastic tubes called catheters. Some of these catheters are only one or two inches long. Others are much longer and are inserted into a vein in the upper arm and extended all the way to the entrance of the heart. These are called peripherally inserted central catheters, or PICC lines.
What is the oral route of giving medicine?
That's called the ''oral'' route of giving a medicine. There are a number of routes by which medications are administered. The most common are: oral (by mouth) parenteral (by injection) topical (on the skin) In the medical world, parenteral refers to administering medications without going through the digestive system.
What is LVP filter?
In LVP manufacture the materials are formulated and prefiltration and final filtration reduce the particle load. Prefiltration removes colloidal or hard particle from the dextrose in solution. The final filter is a 0.45 μm cartridge, with or without a prefilter. Occasionally two final filters in series will be used. LVP filters are expected to provide high consistent flow rates to insure that all product containers are filled accurately and consistently. LVP manufactures operate at extremely high differential pressures and push the limits of the hydraulic strength of a pleated cartridge. A Start-up of greater than 5.5 bar is common, and pressure peaks to 6.9 bar occur. Depending on the percent of dextrose in a solution, the cartridge may contain a cellulose ester prefilter to extend the throughput of the cartridge. A cartridge without a prefilter will decrease the differential pressure across the cartridge and increase the flow rate with cleaner solutions.
What are the ingredients in LVP?
The ingredients in typical LVPs are water, dextrose (5% to 50%), amino acids, salts and occasionally viscous, Total Parenteral Nutrition (TPN) components. Final products include IV suspension bags and Continuous Ambulatory Peritoneal Dialysis (CAPD) exchange solutions. Large Volume Parenterals (LVPs) are different to other pharmaceutical products in that 0.45 μm filtration is used for particle removal prior to terminal heat sterilisation. There is a trend toward filtration to 0.22 μm in the LVP industry. LVPs are single unit doses of volumes greater than 100 cc and as large as 3–5 litres. Batch sizes are in tens of thousands of gallons, multiple filling lines may work in parallel and thus LVP plants operate with very large volumes per day.
What is the bioburden limit for aseptically filled products?
counterparts, even if the product is terminally sterilized. Based upon current practice, for aseptically filled products, the UBPS bioburden limit is 10 CFU/100 mL and for terminally sterilized products, this limit is 100 CFU/100 mL.
What are the limits for parenteral products?
Parenteral product manufacturers should have preset limits on product (unfiltered) bioburden based upon in-house sample data. Generally, alert and action limits are set for each product or class of products. If the action limit is exceeded, the resulting action should be rejection of the batch. Products can be grouped according to intrinsic characteristics such as whether the product is terminally sterilized or aseptically filled, the presence or absence of preservatives in the formulation, and the growth-promoting capability of the excipients or finished product formulation. If no bioburden data exist for a given product or grouping, it is common practice to determine baseline bioburden levels before permanent limits are set. For new products this is usually done during the development or validation batch production stage, provided the final scale and facility are being used. If the product is to be marketed in the European Union (EU), the EP states specific unfiltered bulk product solution (UBPS) limits for terminally sterilized and aseptically filled products. European inspectors tend to be keener on product bioburden than their U.S. counterparts, even if the product is terminally sterilized. Based upon current practice, for aseptically filled products, the UBPS bioburden limit is 10 CFU/100 mL and for terminally sterilized products, this limit is 100 CFU/100 mL. For products marketed in the EU, it is recommended that UBPS bioburden levels remain below these limits for the duration of any proposed product holding periods. In addition, for these products it may be necessary to collect a postfiltration, presterilization sample of filled units for bioburden determination. Finally, a trend analysis system for bioburden results on a product-by-product basis should be put into place. Trend analysis should be carried out by a specially designated interdisciplinary team on a quarterly or semiannual basis. Any upward trends, even if within the alert limits, should trigger an investigation to determine the cause before a larger problem results.
How long is fluconazole stable?
Commercially available parenteral formulations of fluconazole have been reported to be stable for 1-2 years, when stored in glass or plastic bottles at 5-30 °C [4]. Fluconazole has been found to be very stable in a oral liquid formulation (1 mg/mL) when stored at 4, 23, and 45 °C over a period of 15 days [31]. Short term stability studies of fluconazole in injectable solutions have shown these to be stable [32].
How quickly does fentanyl absorb?
Parenteral fentanyl is rapidly absorbed and effects are observed within minutes. Transdermal absorption is temperature dependent. Febrile patients will more rapidly absorb transdermal fentanyl. Skin in contact with the fentanyl patch absorbs drug and becomes a depot of fentanyl. A concentration gradient between the drug in the patch and the skin layers drives the continued absorption of drug. Steady-state serum concentrations are achieved ∼2–24 h after initial patch application in the naive user. Peak serum concentrations of transmucosal fentanyl are achieved within 30–60 min of administration. Epidural concentrations peak after ∼30 min. The duration of action of fentanyl varies according to the drug's route of administration. The effects of an intravenous dose last ∼30–60 min. Transdermal fentanyl patches steadily release drug for more than 72 h. The volume of distribution of fentanyl ranges from 3 to 6 l kg −1. The drug is ∼80–86% protein bound in plasma. Fentanyl is primarily metabolized by the liver. Metabolism occurs via N -dealkylation to norfentanyl and other inactive metabolites. Approximately 75% of the drug is renally metabolized with 10% excreted unchanged in the urine. The elimination half-life varies with route of administration. An intravenous dose exhibits a half-life of ∼219 min, a transmucosal dose 7 h, and transdermal administration 17 h. The half-life may be increased in patients with hepatic dysfunction.
What is parenteral in medicine?
Parenterals are dosage forms intended for injection into the body. Water is normally used as the solvent. The special tests for parenterals include sterility and absence of particles as well as endotoxins that can give fever reactions. The old test that was performed on rabbits is nowadays often replaced by a test based on the reaction of endotoxins with a lysate from Limulus amoebocyte (LAL test), which is less time consuming and more exact. Sterility testing is complicated from a sampling point of view because of the random appearance of microbial contaminants. A thorough in-process validation is the best way to ensure that the products are sterile. In large volume, parenterals' requirements on limits for particle contamination have created a need to analyze for particles down to the size of a few micrometers, usually by light blocking or by conductivity techniques. For compounds that are sparingly soluble in water other solvents or cosolvents can be used creating problems of quite a different kind for both formulator and analyst, such as evaluation of precipitation phenomena and interactions with packaging materials. For freeze-dried (lyophilized) products the reconstitution properties have to be controlled.
parenteral
1. (Medicine) (esp of the route by which a drug is administered) by means other than through the digestive tract, esp by injection
parenteral
English-Spanish/Spanish-English Medical Dictionary Copyright © 2006 by The McGraw-Hill Companies, Inc. All rights reserved.
What does "injected" mean?
Taken into the body or administered in a manner other than through the digestive tract, as by intravenous or intramuscular injection. adjective. 0. 0. (medicine) Administered by some means other than oral intake, particularly intravenously or by injection. adjective. 0. 0. Advertisement.
What is parenteral medicine?
The definition of a parenteral is medicine or liquid that is injected under the skin. An example of a parenteral is the arthritis medication, Enbrel. noun. 2.
What is the meaning of "brought into the body"?
Brought into the body through some way other than the digestive tract, as by subcutaneous or intravenous injection. adjective.
How to use parenteral in a sentence
The recovery of poliomyelitis virus after parenteral introduction into cockroaches and houseflies.
Other words from parenteral
The American Heritage® Stedman's Medical Dictionary Copyright © 2002, 2001, 1995 by Houghton Mifflin Company. Published by Houghton Mifflin Company.
What is the best container for parenteral preparations?
Parenteral preparations may be supplied and stored in a variety of containers, including vials, bottles ampoules and, for large quantities of liquids, bags. All of these containers must be transparent to allow for visual inspection of the content. The container must not contain any materials that may adversely affect the quality of the product during the handling, storage and use. Traditionally glass has been preferred for containers that store parenteral products, especially borosilicate glass which is more resistant to chemical attack than low cost soda lime glass. Plastics are now becoming more common, however, and several types are in common use. The choice of material is governed by the composition of the parenteral product and standards governing the choice of materials are set by the National pharmacopeias, for example the U.S. Pharmacopeial Convention (USP), The Japanese Pharmacopoeia (JP), and The European Pharmacopoeia of the Council of Europe (EP). These institutions set quality standards for active pharmaceutical ingredients, drug products, excipients, packaging materials, labelling and storage conditions,
What is parenteral preparation?
Parenteral preparations are sterile pharmaceutical products administered to the human body by injection. Only liquids can be injected which means that the pharmaceutical parenteral preparation must either be a liquid which can itself be injected safely, or it may be a material that can be diluted with sterile water ...
What is the closure material for a bottle?
These must prevent any microorganism or bacteria from entering, The closure material must be made of compatible material that will allow a hypodermic needle to pass through with minimal disruption or shedding of material and at also has the ability to reseal itself once the needle is removed. Elastomers are widely used as closure materials for bottles. They are also used in other primary parenteral packaging as stoppers for vials, plungers and tip caps for pre-fillable syringes, plungers and seals for cartridges and ports for plastic bags.
What is powder for injection?
These are sterile solid compounds that are distributed in their final volume when the vial or container is shaken to form a clear particle-free solution.
What is required on a parenteral label?
Labelling. Parenteral products labels must include the name of the preparation, active ingredient amount, storage condition and the diluent or solvent required to achieve the desired concentration for the product to be administered.
How are injections prepared?
Injections contain sterile solutions and are prepared by dissolving the active ingredient and other substances in Water for Injection or other suitable non-aqueous base or a mixture of both. The solution to be injected may show sediments which can be dispersed easily by shaking the container.
What are elastomers used for?
Elastomers are widely used as closure materials for bottles. They are also used in other primary parenteral packaging as stoppers for vials, plungers and tip caps for pre-fillable syringes, plungers and seals for cartridges and ports for plastic bags.
How are parenteral suspensions prepared?
Due to the inherent long-term physical instability of suspensions, parenteral suspension dosage forms are formulated as dry powders for reconstitution immediately before administration. The sterile dry powder could be produced by freeze-drying, sterile crystallization, or by spray-drying. Parenteral sus-pensions are prepared by mixing dry powders in sterile vehicles immediately before administration. Examples of parenteral suspensions include penicillin G procaine injectable suspension USP and testosterone injectable suspension USP.
What is parenteral administration?
Injection and infusion are the predominant methods of parenteral admin-istration. Injection via different routes of administration usually utilizes a SVP. An infusion involves the IV administration of a LVP over a prolonged period of time. Infusions are commonly used for fluid replacement, admin-istration of drugs with a short plasma half-life, and/or dilution of a drug immediately before administration.
How many guages are in a parenteral suspension?
Parenteral suspensions should be easily resuspended and passed through an 18 to 21-guage needle throughout their shelf lives. To achieve these prop-erties, it is necessary to select and carefully maintain particle size distri-bution, zeta potential, rheological properties, and wettability. Injectable suspensions often consist of the active ingredient suspended in an aqueous vehicle containing an antimicrobial preservative, a surfactant, a suspending agent, a buffer, and/or a salt.
Why do we use fat emulsions?
Because emulsions can cause pyrogenic reactions and hemolysis, and require autoclave sterilization in addition to their inherent physical insta-bility, their use as IV dosage forms has been limited. Total body nutri-tion is often administered as an IV emulsion to enable coadministration of both water-soluble and water-insoluble nutrients. IV fat emulsion usually contains 10% oil. Fat emulsions yield triglycerides that provide essential fatty acids and calories during total parenteral nutrition of patients who are unable to absorb nutrients through the GI tract. IV lipid emulsions are usually administered in combination with dextrose and amino acids in the aqueous phase.
What is lyophilization in baking?
Lyophilization or freeze-drying is used to prepare powder cakes for reconstitution immediately before administration. It has inherent advan-tages over other methods of preparation of dry powders, such as
Can parenteral products be formulated as solutions?
Parenteral products can be formulated as solutions, suspensions, emulsions, or lyophilized products (solid) for reconstitution immediately before use.
Can you freeze dry liposomal cells?
Despite the advantages of freeze-dry ing, cautions must be taken for lyophi-lizing proteins, liposomal systems, and vaccines, because they tend to get damaged by freezing, freeze-drying, or both. These damages can often be minimized by using protective agents, such as polyols, polysaccharides, disaccharides and monosaccharide.
