Opioid abuse disorder is very common, affecting over 20 million people worldwide and over 3 million people in the United States. People who misuse opioids may also advance to even more harmful drugs such as heroin, making this a critical issue that needs to be addressed. With the help of long-acting injectables for opioid use disorder pharmaceutical development, new treatment options are now available to patients that are more sustainable.

The History of Opioid Use Pharmaceuticals

The first modern opioid crisis began in the 19^th century. During and after the Civil War, this opioid crisis emerged as soldiers were given substances to treat their wounds, pain, PTSD, and depression. As a result, many soldiers developed an opioid addiction. Doctors at this time would give a patient morphine because it was a general cure for all chronic pain problems, but it obviously had negative effects as well.

The opioid crisis dwindled by 1900, and for roughly 90 years opioids were only abused by smaller groups of people. It wasn’t until the early 2000s that the use of opioids once again began affecting communities all over the country. While doctors started to notice the spread of opioids and took steps to curtail it, people were finding other ways to illegally acquire the drugs.

While there are still issues today, we have grown more aware of the risks that are associated with opioid use. There are many efforts being made to hopefully reduce instances of abuse, such as educating those on alternate pain management strategies, developing abuse-deterrent formulations, having stricter prescription guidelines in place, and offering opioid use disorder pharmaceutical development.

Benefits of Long-Acting Injectables for Treating Opioid Use Disorder

Long-acting injectable, or LAI, formulations ensure that patients receive their medications on a regimented schedule. Drugs such as naltrexone and buprenorphine are formulated as monthly injections in order to block the effects of opioids. Initially, these drugs were formulated in daily oral dosages, but LAI products are more effective, as they result in greater patient compliance.

In addition to improved compliance, injectables to treat opioid abuse disorder provide benefits such as:

• Ability to target specific anatomical areas – LAI buprenorphine targets the receptors in the brain, providing effects that help control withdrawal symptoms, reduce cravings, block the euphoric effects of opioids, and maintain stable blood concentrations without peaks.
• Helping to prevent drug abuse – By receiving long-acting injections, patients eliminate the need for daily dosing, reducing the risk of missed doses and relapses.
• Potential for improved outcomes – Injectables help reduce the opportunities for misuse and ensure consistent medication levels are maintained, possibly leading to better outcomes for the patient.

How Oakwood Labs Stands Out

Oakwood Labs has developed 2-, 3-, and 4-month duration prototype formulations of naltrexone, using a different polymer than is used in the 1-month duration naltrexone. We are currently working on scaling up these formulations prior to clinical trials.

We also have a track record of success in bringing other projects from proof of concept to clinical trials, such as proving the duration of release of naltrexone formulations in animal PK models. We are currently seeking partners for clinical development.

By choosing us as a partner in developing injectables to treat opioid use disorder, you’ll benefit from:

• Strong communication and project management that achieves milestones
• Patented microsphere technology that allows tailored release profiles from weeks to one year
• Over 20 years of experience encapsulating sustained-release injectables
• A full-service operation, from R&D formulation development through GMP commercial manufacturing
• An FDA-approved aseptic GMP facility manufacturing clinical and commercial sterile injectables

FAQs on Injectables to Treat Opioid Use Disorder

How do these medications work?

Naltrexone helps block the sedative and euphoric effects of drugs such as codeine, morphine, and heroin. This medication is reported to reduce opioid cravings. Buprenorphine, on the other hand, helps avoid withdrawal symptoms and manage cravings.

What are the current barriers to an LAI entering this particular space?

It is difficult to develop LAI formulations of these drugs, especially for formulations in excess of one month in duration of release. Currently, 1-month duration products have been approved, but no longer than 1-month duration products have been approved yet. Some people are working to develop longer duration products, such as a 2-month duration naltrexone and a 3-month duration buprenorphine. It is generally accepted that longer duration products would be beneficial for patient compliance.

Who are good candidates for injectables?

People who may benefit from injectables for treating opioid use disorder and other conditions include:

• Those who are high-risk, meaning they experience frequent hospitalizations or multiple relapses
• Those who prefer less frequent dosing
• Those who are nonadherent to oral antipsychotics
• Those experiencing dose-dependent adverse effects
• Those who have poor oral absorption

Besides opioid use disorder, what else can LAIs help treat?

Long-acting injectables have been used to treat a variety of conditions such as schizophrenia, bipolar disorder, depression, and more. LAIs have also been used as pharmaceuticals which offer numerous benefits for oncology treatment.

Choose Oakwood Labs for Opioid Abuse Disorder Pharmaceutical Development

If you have an interest in long-acting injectables for treating opioid use disorder, please reach out to us today. We look forward to providing you with more information on how to tackle this ongoing issue in today’s world.

When developing and manufacturing a new drug, the list of requirements can get extensive. With the needs for drug discovery, development research, review, and production, there are a lot of moving parts to ensure that a product is safe for patients once it hits the market.

Due to this, assistance for the different phases of pharmaceutical drug development is often sought out, and these support companies come in the form of CDMOs, CROs, and CMOs, organizations that serve the pharmaceutical and biotechnology industries. Learn more about the differences between these organizations in our post so you can determine which will be the most beneficial during your pharmaceutical development process.

CRO vs. CMO vs. CDMO

Let’s explore the distinctions between the three types of organizations that can aid you in your pharmaceutical processes.

Contract Research Organization

A Contract Research Organization, or a CRO, is a destination for research, including clinical trial management, preclinical research, data management, regulatory affairs, and post-marketing surveillance. These organizations focus mostly on research and development services, including clinical trials and regulatory compliance. This means they are involved mostly in the early stages of drug development and play a major role in the overall research and regulatory aspects of drug development.

CROs largely support pharmaceutical companies in research and regulations. Outsourcing to a CRO allows the pharmaceutical company to focus on building other areas of the business and prioritizing other tasks.

Contract Manufacturing Organization

A Contract Manufacturing Organization, or a CMO, specializes in the production of pharmaceuticals and all things related to manufacturing. CMOs are adept at handling large-scale production once the drug has been developed. Their services are beneficial because they utilize cutting-edge technology and have skilled employees who bring expertise to the development process.

Working with a CMO also ensures that the final product is compliant with both quality and regulatory standards, which allows the pharmaceutical company to focus on other things like drug discovery and marketing.

Contract Development Manufacturing Organization

A Contract Development and Manufacturing Organization, or a CDMO, offers a full range of services, from drug development through manufacturing. With operations in place for process development, scale-up, clinical trials, material production, and manufacturing, a CDMO is your end-to-end partner.

Because they are involved throughout the ensure lifecycle of drug development and manufacturing, CDMO facilities help pharmaceutical companies to reduce costs, accelerate time to market, and ensure regulatory standards are adhered to. Consult a CDMO to bridge the gap between development and manufacturing and achieve the most comprehensive solution.

Which Partner Is Best for You?

When deciding which organization to work with, be sure to analyze your company’s needs and challenges. If you are seeking a partner for clinical research support, a CRO is your answer. When you need manufacturing help, a CMO is going to be an ideal match. And if you want to outsource the entire process and ensure everything goes smoothly, a full-service CDMO is going to provide comprehensive and integrated development, support, and manufacturing. When you are looking for a reliable CMO or CDMO partner, Oakwood Labs is here to help.

At Oakwood Labs, we offer CDMO and CMO services for your convenience, and our team has over 25 years of experience with developing and manufacturing injectables for the pharmaceutical industry. We specialize in sustained-release and targeted-release injectables for long-term therapeutic relief. Along with this, our facility follows GMP aseptic manufacturing processes to provide FDA-approved pharmaceuticals to our clients.

Learn More About Our Abilities as Your Pharmaceutical Partner

Please contact us today to learn more about everything we can provide as your CMO or CDMO partner. We look forward to assisting you.

Oakwood Labs is a global leader in sustained-release drug delivery. Our facility provides feasibility studies, analytical development, scale-up capabilities, GMP clinical trial material, GMP contract manufacturing, and sterile fill-finish.

Sterile fill-finish is the final leg of the pharmaceutical manufacturing process, where a substance is filled into vials, ampoules, or other containers deemed appropriate. After the substance is put into containers, it is ready to be sent out for distribution. Learn more about our capabilities for this part of the process below.

The Process for Fill-Finish Pharmaceuticals

There are a variety of reasons that sterile fill-finish is essential in the manufacturing of long-acting injectables. Patient safety is at the top of the list, however, as the approach ensures that the product is free from microbial contamination.

What the Process Entails

When you begin the sterile fill-finish step, you are almost at the end of the drug manufacturing process. However, this is a critical point of the overall manufacturing process because it needs to be done correctly to ensure that your drug is safe for patients. At this point, you’ll want to request help from a fill-finish CDMO who can oversee the process properly.

Some of the steps that will be completed will include:

• Filling – In the filling process, the drug is placed into the final product containers under controlled and sterile conditions. Finish and fill services must be completed in a sterile environment to prevent contamination. For this reason, these services are performed in a cleanroom that has controlled air quality, temperature, and humidity. Additionally, it is important to ensure that sterile filling techniques are also applied to equipment and packaging.
• Container closure – It is important to select the appropriate container closer that is going to maintain the sterility and stability of the drug. Whether this is a vial, syringe, ampoule, or something else, the team you work with will help find the right solution for your application.
• Quality control – In the process of fill-finish for pharmaceuticals, rigorous quality control is practiced to ensure that the product meets regulations. Not only is the product tested throughout the process, but it also undergoes environmental monitoring and final product review to ensure that it is sterile and potent, and that it meets all other criteria that is required.
• Labeling and packaging – Once the product is filled, the finished item is labeled and packaged according to regulations and any requirements provided by outside sources.
• Regulation compliance check – It is important for aseptic, CDMO facilities to adhere to regulatory guidelines like Good Manufacturing Practice (GMP). This helps to ensure safety, efficacy, and quality, completing the final steps of the finish and fill process.

When you choose to work with a fill-finish CDMO, you can also receive different batch sizes to meet your project’s needs. From small-scale clinical trials to large-scale commercial production, our processes can be adapted to your specifications.

Let Oakwood Labs Be Your Fill-Finish CDMO

Oakwood Labs operates a fully compliant aseptic GMP facility. Our FDA-approved facility is headquartered near Cleveland, Ohio and centers on the development and manufacturing of sustained-release injectables for the pharmaceutical industry. We focus on creating pharmaceutical products that provide therapeutic benefits to our patients and excellent returns for our partners.

Whether you need assistance with fill-finish pharmaceutical services or something else, we are here to help. Other services we provide include:

• Formulation and analytical development activities
• Accelerated and long-term stability studies
• Scale-up, validation, or engineering batches
• Complete method transfer and validation
• Batch record and protocol development

Consult Our Finish and Fill Services Today!

If you are in need of pharmaceutical manufacturing, partner with Oakwood Labs to receive reliable and efficient services.

Contact us today to learn how you can achieve a sterile fill-finish with our CDMO.