Secret Ways To Save Money On Preclinical Animal Studies For New Drugs & Pharmaceuticals
What factors do you need to consider for drug administration to animals?
The administration of substances (drug or placebo formulations) involves minimizing the pain and suffering of the animals used in the regulatory study. Multiple routes of delivery are used for parenteral products. Once an administration route is selected, based on therapeutic use in patients, other factors such as drug volume, drug dosage, and injection pH are considered for optimal animal study design. Personnel training deficiencies or inattention to detail during animal study execution may harm the animals or experimental results, costing time and money. Details on the top four parenteral administration routes for animals (intravenous, subcutaneous, intramuscular, and parenteral) are described below so that you can save time and money on your animal studies. This article covers considerations for preclinical studies animal models and animal drug tests (drug testing in animals).
What is the lesser-known secret to saving money on preclinical animal studies for investigational new drugs?
The requirements for human clinical studies are much more stringent than those for small or large animal studies. Thus, for animal studies requiring injections, contract manufacturing companies (such as MycoScience) can be used to save money on aseptically-filled products. Cost savings for filling products for animal studies with companies like MycoScience come from the ability to fill smaller batch sizes at a reasonable price point.
What factors should you consider for Intravenous drug administration to animals?
Intravenous drug delivery is the most efficient means of delivering substances during animal drug tests because it bypasses the need for drug absorption into bodily tissues. Drug testing animals via intravenous delivery can be through a bolus injection or an infusion into the blood vessels. For infusions, spring-operated disposable pumps are the most economical choice. However, precision electronic infusion pumps or microdrop infusion equipment are more accurate.
Drugs (and their placebo counterparts) delivered intravenously must be sterile and administered aseptically. In addition to being sterile, drug formulations for animal drug tests should meet FDA requirements for particulates. Substances known to burst blood cells intravenously, like cremaphor and some alcohols, surfactants, and excipients, shouldn’t be included in the parenteral product formulation. Butterfly needs for single injections, topical anesthetic creams or ointments before injection, external pump packs to encourage normal animal movement, and small catheter/needle sizes all enhance animal comfort and experimental outcomes. As with a human patient, animals in preclinical studies should be monitored for fluid overload during infusions. Also, chronically implanted catheters or vascular access ports should be cleaned regularly to prevent infection.
What factors should you consider To Save Money On Preclinical Animal Studies for subcutaneous drug administration?
Nonirritating drug formulations can be injected subcutaneously. Subcutaneous injections are inexpensive and quick. However, subcutaneous products are absorbed by the body at a slower rate. Formulations delivered subcutaneously have less particulate and excipient restrictions. Aqueous or oily fluids can be delivered subcutaneously. Also, solid pellets or implants can be administered subcutaneously either through injection or surgery. Subcutaneous injections require minimal training; however, personnel should be careful to ensure inadvertent intravenous injections do not occur. As with intravenous injections, drug formulations should be sterile and aseptic techniques performed during the injection. For the best results, syringes filled via vials should use one needle for filling and a separate needle for injection. Two needles are recommended because passing a small-gauge needle through a thick rubber stopper dulls the needle’s point and enhances animal discomfort/irritation during the injection.
What factors should you consider To save money on preclinical animal studies for Intramuscular drug administration?
Intramuscular administration is used in large animal studies but often avoided in small animal models where muscle mass is small. Muscle tissue has a wonderful vascular supply and thus distributes drugs rapidly and uniformly throughout the body. Intramuscular injection volumes are smaller than injection volumes for subcutaneous delivery. Also, intramuscular delivery requires skill to avoid inadvertent damage to nerves such as paralysis or muscle necrosis.
What factors should you consider for intraperitoneal drug administration to animals?
Peritoneal cavity injections (intraperitoneal injections) are utilized in rodents instead of intravenous injections. Intraperitoneal injections are rarely used in large animals or humans. Unlike intravenous injections, intraperitoneal injections can deliver large fluid volumes safely. However, intraperitoneal drug adsorption is traditionally slower than intravenous adsorption. Additionally, intraperitoneal pharmacokinetics are more similar to oral administration because drugs administered intraperitoneally may undergo liver metabolism before reaching the systemic circulation. Formulations injected intraperitoneally must be sterile, isotonic, and nonirritating. Adhesions can form in ileus or peritonitis if Irritating substances (like undiluted chloral hydrate) are injected. Ensure technicians are trained in intraperitoneal injections to avoid inadvertent subcutaneous, intracecal, or intracystic injections.
Summary
Overall, preclinical animal studies are investments that require large volumes of time and money. Save money on preclinical animals studies through selecting cheaper options for drug filling and administration. For example, the requirements for human clinical studies are much more stringent than those for small or large animal studies. Thus, for animal studies requiring injections, contract manufacturing companies (such as MycoScience) can be used to fill sterile products inexpensively. Additional details on the top four parenteral administration routes for animal studies (intravenous, subcutaneous, intramuscular, and pararenal) are described here so that you can further save time and money on your animal studies. All in all, if you are undergoing preclinical animal studies for a new drug or therapy, consider choosing a contract manufacturing organization like MycoScience to support your unique product filling needs inexpensively and on time.
MycoScience is a contract manufacturing organization specializing in sterile syringe and vial filling cosmetic products or for products used in animal studies. In addition, MycoScience offers testing services, including Preservative Efficacy Testing, Cytotoxicity Testing, Bioburden Testing, Cleaning Validations, Microbial Aerosol Challenge Testing, Accelerated Aging, Microbiology Testing, EO Residual Testing, Bacterial Endotoxin Testing, Package Integrity Testing, Sterilization Validations & Environmental Monitoring services medical devices and allied industries. MycoScience is an ISO 13485 certified facility.
References
Patricia V Turner, Thea Brabb, Cynthia Pekow, & Mary Ann Vasbinder. Administration of Substances to Laboratory Animals: Routes of Administration and Factors to Consider. Journal of the American Association for Laboratory Animal Science. 50(5): 600–613. 2011.
