Parenteral drug administration is the delivery of medications or other substances through routes other than the digestive tract. The medication goes directly through the body while bypassing the gastrointestinal system, allowing rapid absorption into the bloodstream.

This form of treatment is used when immediate therapeutic effects are necessary, the patient is unable to take oral medication, or the medication is not offered in an oral form. Read on for insights about parenteral administration and the process for manufacturing drugs that use the application method.

Enteral vs. Parenteral Drug Administration

Enteral and parenteral are two common routes for administering medications and treatments to patients.

Parenteral drug administration delivers nutrients directly into the body without the digestive system through injections or infusions. It is used when there is a need for immediate therapeutic effects or when oral administration is not feasible. This method requires specialized training and equipment to ensure safe administration. Risk of infection or other complications may occur if it is not performed correctly.

Another method of drug administration is enteral. It delivers medications or nutrients through the gastrointestinal tract by way of oral administration or a feeding tube. This means that the digestive system must be fully functioning in order to absorb the medications or nutrients. Since it is the natural route for nutrient absorption, it is generally considered safer than parenteral drug administration. However, the absorption may be influenced by factors like gastric emptying, gastrointestinal mobility, other drugs, and even food. Additionally, the patient must be able to accept oral drugs.

Overall, parenteral administration is used when there needs to be immediate relief or a bypass of the digestive system, while enteral administration is employed when the digestive tract is functioning and able to absorb nutrients and medications. Therefore, when choosing whether to manufacture enteral or parenteral drugs, it is essential to fully understand the needs of your targeted demographic of patients to make an informed decision.

The Benefits of Parenteral Drug Administration

One of the main benefits of parenteral drugs is the fact that they offer very precise dosages. This is because the drugs are administered directly to the site for treatment, which means their absorption rate is greater than if they were to pass through the metabolism first.

Other benefits of parenteral drugs for patients who need a variety of therapeutical treatments include:

• Rapid action – Parenteral drug administration medications can be directed into the bloodstream, which results in a rapid delivery of the drug. They are absorbed quicker than medications with oral administration, resulting in immediate therapeutic effects that are extremely useful where quick relief is necessary.
• Predictable absorption – Parenteral drug absorption tends to be more predictable than oral administration, which is important for medications with small therapeutic windows.
• Reduced gastrointestinal irritation – Some drugs can cause irritation and damage to the gastrointestinal tract, which can cause a lot of discomfort to the patient. Parenteral administration doesn’t involve the digestive system which reduces these complications.
• Avoidance of first-pass metabolism – Drugs administered orally must pass through the liver before they can reach the targeted spot. When the drug is metabolized, its effectiveness can be reduced because less of the drug travels into the systemic circulation. However, parenteral administration bypasses this metabolization which can result in a greater proportion of the drug meeting the intended site.

Another benefit of parenteral administration is the improved patient compliance. Patients who experience side effects of oral medications and opt for parenteral drug administration could experience less discomfort when going through treatment. This means reduced nausea, vomiting, and difficulty swallowing, which can result in better adherence to therapy plans.

Methods of Parenteral Administration

There are many ways to administer parenteral drugs. Some are more popular than others, but the method highly depends on the needs of the patient.

Some of the most common methods of parenteral drug administration include:

• Intravenous – Delivered directly into the vein, which is the fastest and most direct route
• Intramuscular – Injected into a muscle, which allows for absorption over a longer period of time when compared to an IV
• Subcutaneous – Injected into the fatty tissue beneath the skin which is beneficial for medications that require slower and sustained absorption

However, the list does not stop here. Other administration methods include:

• Intraosseous – Delivered directly into bone marrow, which is common for emergency situations where IV access is limited or difficult
• Intradermal – Injected into the dermal layer of the skin, which is used for some allergy testing and certain vaccinations
• Intracardiac – Directed toward the heart which is useful for cardiac resuscitation procedures
• Intra-articular – Injected into a joint space which is commonly used to treat inflammatory joint conditions

While there are many avenues for parenteral administration, not all drugs can be delivered this way. While many of them can, there are certain exceptions for select medications, and some drugs have specific requirements or restrictions for parenteral drug administration. So, as a manufacturer, it is critical to develop clear instructions for delivery.

The Process of Manufacturing Parenteral Drugs

Since we manufacture pharmaceuticals, we wanted to touch upon the typical manufacturing process for parenteral drugs that ensures they are sterile and safe.

Here is a simple overview of the process:

1. 1. Develop the formulation using active pharmaceutical ingredients, excipients, and other components that will achieve the desired therapeutic effect.

• Create a sterile environment that is controlled. This typically involves the use of cleanrooms or isolators that are equipped with advanced air filtration or purification systems to ensure sterility.

• Weigh and mix the API, excipients, and the other components to ensure an even distribution.

• Sterilize the mixture to remove microorganisms. This step is crucial since the parenteral drugs are administered directly into the body. Sterilization can be done through filtration, autoclaving, or aseptic processing.

• Fill the sterile drug formulation into appropriate containers like vials and pre-filled syringes. This should be done under aseptic conditions to prevent any contamination. Then, the containers are sealed in a way that maintains the sterility of the drug.

• Label and package the formulation with information about the drug.

• Test samples from each batch to check the potency, purity, sterility, endotoxin levels, and more.

• Check the stability of the formulation to see the drug’s quality and efficacy over time.

• Submit applicable drug information to the FDA to ensure that it is ready for parenteral administration in hospitals, doctors’ offices, and more.

After this process is concluded, it is time for the drug to be shipped off so that it can be used in parenteral administration for patients.

Oakwood Labs Is Your Destination for Manufacturing Parenteral Drugs

It is any manufacturer’s job to adhere to Good Manufacturing Practices (GMP) to ensure product safety and quality. We’re committed to doing so, and since our founding in 1997, Oakwood Labs has grown to become one of the prominent manufacturers of sustained-release parenteral products. We operate in an FDA-approved, aseptic facility, meaning we are ready to tackle your next manufacturing project.

Through our patented Chroniject™ and contract manufacturing services, we can help you treat more patients with the use of parenteral drug administration.

Contact Us Today for More Information

For more information on parenteral drug administration and its manufacturing processes, be sure to contact Oakwood Labs.

Biologics are drugs produced using a living system, like microorganisms, plant cells, or animal cells. The particles used in biologics are made through complex processes and are at the center of a variety of products like vaccines, monoclonal antibodies, recombinant proteins, gene therapies, and beyond.

Biologics are reinventing the way we view the pharmaceutical landscape because they are innovative solutions that provide therapeutic benefits to patients with a wide range of diseases and conditions. Learn more about this fascinating technology and discover how it is being used to help provide relief to a variety of patients in our post.

The Origin of Biologics in Pharmaceuticals

The first use of biologics in medicine traces back to the late 19^th and early 20^th centuries. Emil von Behring was the first to make the discovery while working on a serum therapy for diphtheria. However, it was Paul Ehrlich’s work on the “magic bullet” that started the movement for the use of biologics in targeted drug delivery. Together, the work of von Behring and Ehrlich led to the development of vaccines that worked against infectious diseases, marking the earliest successes of biologics in medicine.

It is safe to say that a lot has evolved since the discovery of biologics in medicine, and regulation has played a key role. The use of biologics in medicine started to be regulated by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) in the early 2000s. These organizations set specific guidelines in place to ensure any produced drugs are safe and transparency is maintained for patients.

Regulating Biological Medicine

The FDA and EMA oversee the approval for regulation of biological products. The approval process is rigorous to help ensure the safety, efficacy, and quality of each product released to the public. For this to happen, each biological medicine goes through both clinical and preclinical testing. The clinical trials include three phases of testing.

Once a biological drug is approved for use on the market, agencies continue to monitor the safety of it through surveillance programs. Adverse and other side effects are reported and evaluated. Products will be taken off the market if serious safety concerns arise. Additionally, there are thorough investigations conducted specifically for the use of biologics in the pediatric and geriatric populations.

Lastly, there are strict quality control measures in place to ensure consistency throughout the manufacturing process. Biologicals must be manufactured in a GMP facility. Additionally, there must be a label on the drug that describes product information like dosing, administration, potential side effects, and contraindications. Together, these factors work together to keep patients safe while encouraging the evolution of treatment for appropriate populations.

Using Biologicals in Pharmaceuticals to Provide Therapeutic Benefits to Patients

Following their discoveries, von Behring and Ehrlich truly started a movement when they began using biologicals in pharmaceuticals. Since these two found success back in the early 19^th and 20^th centuries, a variety of other discoveries have been made.

Here are some other astonishing biologic discoveries that have shifted the way that patients are treated:

• Recombinant DNA technology used the genetic engineering of bacteria to produce human proteins like the insulin growth hormone and revolutionized diabetes treatment
• Monoclonal antibodies were discovered, opening up new opportunities to prevent organ transplant rejection
• Growth hormones were developed to help children who had growth disorders
• Cytokines were understood on a deeper level which resulted in therapeutic treatment for immune disorders like asthma, rheumatoid arthritis, Lupus, Cohn’s Disease, and more
• Gene therapies like Kynriah can be used to treat certain types of cancer
• mRNA can be used in vaccine technology, such as with the COVID-19 vaccine

Combining Biological Medicine with Sustained Release Technology

Since Oakwood Labs uses sustained-release technology, it would be amiss to not look at biologics for this form of therapy. Biologics can be modified to achieve specific release patterns that enable controlled and sustained drug delivery in patients. This leads to reduced dosing and better therapeutic benefits for patients who need it.

Here are the main methods that incorporate the use of biologicals with sustained-release technology:

• Microspheres/nanoparticles – Biologics can be encapsulated within microspheres and nanoparticles that are made out of biocompatible materials. Then, these particles can be engineered to release the biologic over an extended period of time. The encapsulation is helpful for protecting the biologic from degradation and can be used to enhance stability.
• Implants – Biologic medicine can be encapsulated within implantable devices like biodegradable scaffolds. As the scaffold breaks down, it will slowly release the biologic which is useful for localized and long-lasting treatments.
• Hydrogels – Hydrogels are water-absorbing polymers that hold water and biologics. Gels can be designed to have sustained release qualities to maintain a consistent concentration of the therapeutic agent for extended periods of time.
• Fusion proteins – Engineering fusion proteins is done by combining a biologic with a carrier protein. The carrier protein helps extend the half-life of the biologic which creates a sustained release effect.

Benefits of Incorporating Biologics into Medicine

Using biologics in medicine has proven its success in countless ways across the industry. Biologics can benefit each patient in different ways, and this depends on what they are being treated for.

Here are just a few of the properties that biologics possess and why they are trusted to form new treatments:

• Targetable – Biologics can be targeted to reach specific molecules, cells, or even pathways, which encourages precise treatment while simultaneously reducing the risk of attacking healthy cells or tissues.
• Diverse – Effective therapeutic outcomes can be achieved for a wider audience since biologics can be personalized with a patient’s unique genetic makeup in mind.
• Innovative – Thanks to advancements in technology, biologics are used to treat diseases that were previously difficult to target with small-molecule drugs. Examples include autoimmune disorders, certain types of cancer, and rare genetic diseases.

Biologics in Pharmaceuticals vs. Small Molecule Drugs

From their composition to their manufacturing processes, there are a variety of ways that biologics differ from traditional small-molecule drugs.

• Composition – Biologics are large, complex molecules that are derived from living organisms. They are produced using biotechnical processes. Small-molecule drugs are chemically synthesized with a smaller-sized molecule. They have a defined number of atoms.
• Action course – Biologicals have highly specific mechanisms of action that allow them to target specific cells, proteins, and receptors. This makes them especially useful in precision medicine and targeted therapy treatments. However, small-molecule drugs have a tendency to interact with a wide range of molecules due to their small size and structure.
• Stability – Since biologics are sensitive to environmental factors like temperature and pH, their stability and shelf life are often shorter than those of small-molecule drugs.

Contact Us Today for More Information

Biologicals are at the forefront of biomedical research. With time, we can expect them to offer effective treatments for a variety of medical illnesses and conditions that have formerly been difficult to treat.

If you have any questions about biological medicines or the future of their impact in the world of pharmaceuticals, be sure to reach out to our team.