Extended-release drugs are very common in the pharmaceutical industry but can be difficult to understand and identify. For example, oral medications can be labeled with different acronyms such as ER, SR, and CR, which stand for extended release, sustained release, and controlled release.

It is important to note that “extended-release pharmaceuticals” is an umbrella term for both sustained- and controlled-release pharmaceuticals. These drugs are part of a series called modified-release dosage forms, which refers to the medication’s time-release technology.

Typically, the drugs you ingest are immediate release, which means they are instantly activated when they are ingested. However, extended-release, sustained-release, and controlled-release drugs are modified pharmaceuticals designed to release at a delayed or slower rate to change how and when the drug hits your system.

A Breakdown on Extended-Release Pharmaceuticals

Extended-release drugs were created to offset the side effects that come with traditional, immediate-release drugs. IR drugs are designed to release a spike of medication into the bloodstream that then tapers off. Because of this, extended-release pharmaceuticals offset that spike of medication to provide a steadier amount of medication into the body.

Controlled-Release Medication

• These are medications that are labeled with “CR” at the end of their medical names
• CR drugs can release active ingredients at a very specific rate to ensure there is a constant medication flow in the body for a specific period of time
• Due to their medication-regulating abilities, fewer doses are required throughout the day

Sustained-Release Medication

• These are medications that are labeled with “SR” at the end of their medical names
• SR tablets or capsules prolong the medication’s release to dole out the benefits of the medication over a longer time period
• Although the medication is released over a longer period, the medication levels do not remain constant while in the body

Extended-Release Injectables from Oakwood Labs

Here at Oakwood Labs, we are your source for extended-release injectables. With over 20 years of drug encapsulation experience, we have patented technology to control particle size, customize release durations, and minimize residual solvents.

Our team of professionals has the ability to perform research and develop specially formulated extended-release injectables for our customers’ specific needs. Some benefits of our extended-release injectables include:

• Reducing the number of injections needed
• Ability to target specific anatomical areas
• Improved patient compliance
• Helping to prevent drug abuse

Extended-release drugs make it simpler for individuals to take medications on a regular basis, as these drugs are easier for the body to tolerate in comparison to immediate-release pharmaceuticals. Due to their modified composition, fewer doses are required, making it simpler to stick to a medication schedule.

Overall, extended-release pharmaceuticals allow your body to feel the effects of the specific medication over a longer time period, but via fewer doses. Understanding the specifics of extended-release drugs is important so you can predict how your body will react.

Contact Us for Extended-Release Drugs

Oakwood Labs is the best source for long-acting injectable manufacturing. Not only are we an industry leader in injectable pharmaceutical development, but we are very committed to quality and customer satisfaction.

If you have questions on extended-release injectables, contact us today for additional information!

Related Blog Posts

• Sustained Release Drugs vs. Controlled Release Drugs: What’s the Difference?
• What Is Sustained Release Technology and What Are Its Benefits in Pharmaceuticals?
• A Look at Extended-Release and Modified-Release Drugs

Oakwood Labs is experienced in scaling up and reproducing microparticles for pharmaceuticals. Microparticles are a popular choice for pharmaceuticals because they have multiple routes of administration, can be utilized with a wide variety of drugs, protect biomolecules from degradation, and can perform site-specific controlled releases.

Applications for Microparticles in the Pharmaceutical Industry

Microparticles are generally made up of proteins or synthetic polymeric materials. They can be found in sizes ranging from 1 to 1000 mm, making them ideal for many different applications, including vaccines and other treatments. The following applications describe how they ease patients in need of relief and help the industry:

• When found in small sizes, microparticles are used for inhalation delivery because they are easily dispersed and aerodynamic, allowing them to travel to the deeper regions of the lungs.

• In addition to their role in transferring treatment to deep regions to the body, microparticles play an important role in the treatment and diagnosis of various cancers, including brain cancer, lung cancer, colon cancer, breast cancer, and ovarian cancer.

• Microparticles used in drug delivery have also shown promising results in reducing the treatment time of tuberculosis since they enhance the efficacy of the antibiotics delivered.

Reasons to Use Microparticles in Drug Delivery

Since they were first introduced to the medical field, microparticles have improved the efficiency of different medical treatments. The following advantages describe the benefits of using microparticles in drug delivery:

• Protective coating – Using microparticles supplies bioactive drugs, proteins, and small molecules with protection from degradation. This allows the microparticles to travel freely to their intended destination.

• Controlled release – Microparticles have the ability to effectively achieve a controlled release rate of encapsulated drugs, whether over a period of hours, weeks, or months. This can help in treating patients who forget to take their medication or those who do not want to attend as many appointments.

• Effective for various applications – Microparticles are effective because they can be used for a variety of drugs and can therefore be used in a variety of treatments. For example, they help cancer patients by reducing the number of chemotherapeutic drugs used in patients, reducing the side effects that the patient would otherwise experience.

How Oakwood Labs Can Help in Developing Effective Delivery of Microparticles

At Oakwood Labs, we specialize in formulating microparticles for pharmaceuticals. From the duration of release to the needle size, we work to determine the optimal product characteristics for your project. Other factors that we consider for your project include the following:

• Active pharmaceutical ingredient (API)
• Particle size
• Vial size
• Appropriate solvent system
• Selection of polymer
• Stable state levels
• Method of administration
• Drug load

Our Process for Incorporating Microparticles in Drug Delivery

After we determine the proper characteristics for your microparticle drug delivery, we begin the process of a feasibility study which will determine if the target profile is attainable with our technology. This process includes the following:

• Pre-formulation activities – Pre-formulation activities are used to develop the best approach for the production of microparticles.

• Completing feasibility formulations – The next step is to complete feasibility batches on a small scale. This data is later used to determine the microparticle weight, size, flow rate, and other factors.

• Finalizing reports and choosing formulations for testing – Our team will compile all of the appropriate data and results to form a summary of the microparticle After this, we will provide recommendations for candidate formulations that will be tested on animals. For the use of microparticles in pharmaceuticals and beyond, animal testing is outsourced.

• Further modification and scaling up – After animal testing, we determine the capability of the in vitro release test and use this in situations where further modification is necessary. At this point, the microparticle drug delivery system is ready to begin the process of scaling up.

Start the Process of Using Microparticles in Drug Delivery Today

When you are ready to include microparticles in your pharmaceuticals, be sure to work with a team that carries over 20 years of experience working in an aseptic, FDA-approved manufacturing facility.

Contact us today to learn more.

When pharmaceutical companies set out to create new drugs or modify existing ones for innovative applications, the process is necessarily complex, intricate, and thorough. Since any medication goes beyond its status as a product and affects the health and wellbeing of patients, ensuring that these drugs are held to rigorous quality standards and are produced within facilities adhering to the same is essential.

At Oakwood Labs, our dedicated team supplies support for all phases of long-acting injectable development, facilitating a systematic technology transfer process that ensures our clients’ products are delivered safely and securely.

About Technology Transfer for Pharmaceuticals

Technology transfer refers to the process of new inventions and innovations being transformed into products ready for commercialization. While much of the work for these inventions and innovations can occur within lab settings, the results are often intellectual property owned by and created on behalf of corporations or start-ups.

Because of this, the technology transfer process for pharmaceuticals and other focuses seeks to protect the intellectual property of these institutions so that their products can be properly commercialized and monetized, while benefitting medical facilities and patients at large.

Other aspects that can be components of technology transfer for pharmaceuticals include the following:

• Working alongside legal departments securing patents and other rights
• Determining commercial viability of innovations
• Advertising technologies to varied parties
• Teaching principles of and strategizing for commercialization
• Obtaining funding for research
• Planning licensure agreements
• Strategizing business plans for product implementation

As you can see, technology transfer encompasses a wide array of aspects and Oakwood Labs is proud to play a vital role in ensuring that products are crafted to institutions’ specifications and expectations. This helps to guarantee that innovative medicines can advance to further stages and be brought to market, bringing varied advantages to both companies and patients.

Beyond the Technology Transfer Process: Everything That Oakwood Labs Can Provide

When you partner with Oakwood Labs, you gain access to a team with over 20 years of drug encapsulation experience who has provided services for global pharmaceutical firms of diverse sizes. Our expertise in sustained-release drug delivery allows us to provide the reliable, injectable microsphere-based formulations that our clients require.

We are able to supply a host of services and benefits for our clients, such as:

• Chroniject™, our patented microsphere-based technology
• R&D formulation development
• Efficient and stringent process controls
• Tailored release profile from weeks to one year
• GMP manufacturing under rigorous in-house quality systems
• Contract manufacturing services
• An FDA-approved, aseptic GMP facility
• Demonstrated lot-to-lot reproducibility with proven scale-up success
• A strong focus on communication and project management
• A track record of success for taking projects from proof of concept to clinical trials

If you’ve been searching for a trustworthy lab to work on your project and facilitate technology transfer for pharmaceuticals, choose Oakwood Labs. We have the facilities, expertise, and team needed to deliver.

Reach Out to Oakwood Labs Today

To ask our team questions about our processes, or to get started on a project, feel free to contact us. We’ll discuss your goals with you and help determine the best approach to realizing them.

In the world of medicine, there are several methods by which clinical professionals administer drugs to their patients for the purposes of treatment, recovery, illness prevention, and/or relief. The most widely known methods of administering drugs are orally, topically, and via injections.

Choosing the most effective method is based on many different factors but include the patient and their medical history, desired outcome, type of drug, and more. Long-acting injectables are one method of drug administration that is particularly favorable among clinical professionals due to the convenience and effectiveness. Below, we’ll review the benefits of different types of long-acting injectables and how they are developed and manufactured. 

What Is a Long-Acting Injectable?

A long-acting injectable is an injection method which allows for the gradual release of medication into the bloodstream. There are different types of long-acting injectables, and their effects can last anywhere from two to twelve weeks with just one dose depending on the medication.

Different types of long-acting injectables are commonly used as alternative treatments for those individuals who have trouble taking daily or regular medicines in the form of liquids, tablets, or capsules.

Different Types of Long-Acting Injectables

Since their introduction into clinical practices in the early 1960s, long-acting injectable antipsychotic drugs have been widely used as maintenance therapy and a reliable treatment option for those with psychotic disorders, such as schizophrenia.

These different types of long-acting injectables vary in terms of how often they need to be administered as well as how long their medical benefits will last. A few of the most commonly administered long-acting injectable antipsychotic drugs used today include:

• Fluphenazine
• Haloperidol decanoate
• Risperidone

Answering the Question: Why Are Different Types of Long-Acting Injectables Important?

Long-acting injectable drugs allow for the slow release of medicine into the blood and their effects can last anywhere from two to twelve weeks, making them a practical option for those who have trouble taking medicine on a regular or daily basis. Other benefits of these different types of long-acting injectables include:

• No need to remember to take medications every day
• Routine interactions between patient and medical staff for injection visits
• Overall reduced relapse frequency and rehospitalization rates
• Reduces the risk of accidental or purposeful overdose
• Treating patients with more stable plasma concentrations than oral medications

Considerations When Utilizing Long-Acting Injectables

As with any clinical solution or medication, there are potential side effects to these different types of long-acting injectables that are dependent upon various factors. Some considerations to these drug alternatives may include:

• Prolonged period to achieving steady-state levels
• Slow dose titration
• Less flexibility of dose adjustment
• Delayed desertion of distressing and/or severe side effects
• Pain at the injection site can occur
• Leakage into the subcutaneous tissue and/or the skin can cause irritation
• Burden of frequent travel to outpatient clinics or home visits by community nurses for their administration
• Perception of stigma

Many Different Types of Long-Acting Injectables Can Be Manufactured at Oakwood Labs

Oakwood Labs is a leading developer of sustained-release pharmaceuticals with over 20 years of drug encapsulation experience. We offer support throughout the development of different types of long-acting injectable, ultimately achieving a product that provides greater remedial benefits to patients around the world.

Our facilities can provide the following to help achieve your project goals, including those involving various types of long-acting injectable:

• Pre-formulation development
• Feasibility studies
• Scaling formulation
• Toxicology batch manufacturing
• ICH compliant stability tests
• Phase I, II, and III clinical trial manufacturing
• GMP manufacturing (commercial and aseptic)

Contact Us Today to Learn More!

Long-acting injectables are a proven method to preventing the intense symptoms associated with mental illnesses and psychotic disorders. Using this clinical method has the ability to put patients on the path to a more stable and prosperous life.

The team at Oakwood Labs is ready to assist in the development and manufacturing of different types of long-acting injectable drugs. Reach out today to get started on your next project with us.

We look forward to working with you!

When a company is thinking of releasing a new drug product into the pharmaceutical market, there are multiple steps to be accomplished before the drug is announced.

The first step is conducted through two different studies. At Oakwood Labs, we first select a target formulation to receive tests during the feasibility study and then again with the in vivo animal study. After that is complete, it’s then time for the scale-up process to commence.

Understanding what pharmaceutical scale-up is and the importance of the process in the pharmaceutical industry can help businesses increase the number of products that are growing in demand.

Defining the Scale-Up Process

The scale-up process is designed to increase the amount of an existing product, taking production from a smaller scale to a larger scale during a short duration of time.

Our pharmaceutical scale-up process involves increasing the development of the formulation while still making the same product attributes as we normally would. Through the scale-up process in pharmaceuticals, we offer our clients quality assurance and validations to any concerns they may have. 

Important Factors to Consider for the Scale-Up Process in the Pharmaceutical Industry

When tested drugs are ready for the pharmaceutical scale-up process, there are important factors to consider. To make sure your product is in an ideal position for market success, there is a need for focused and careful planning. Also, when drugs are first going through the pharmaceutical scale-up process they are continuously being optimized. Within our continuous flow process, the equipment we use to manufacture prototype formulations is the same that is used to manufacture full-scale lots, facilitating an easy transition and ensuring the process goes smoothly.

Familiarizing Yourself with the Different Scale Stages

There are different stages of the pharmaceutical scale-up process that drugs undergo. When a drug is in the first stages of receiving tests, it is at the laboratory-scale level. Pilot scale follows and is designed for the purpose of expanding clinical trials. Production scale for commercial use is the final scale in the cycle and is implemented when a new drug is approved. At Oakwood Labs, we can guide your product through the needed scales, providing consistency and reproducibility that lead to the best results.

Contact Us Regarding Our Scale-Up Process in Pharmaceuticals

If you’re in need of scale-up for your pharmaceutical products, be sure to reach out. We are an industry leader in sustained-release injectable pharmaceutical development and manufacturing, and we are committed to supplying products that provide enhanced therapeutic benefits to patients.

Contact us to learn more about the pharmaceutical scale-up process or our other manufacturing capabilities.

Clinical trials are defined as research studies that involve people. They are carefully planned and designed to test the side effects, efficacy, and interactions of a new drug, and they involve four vitally important steps, with each phase revealing more about the drug and its potential.

A Phase 3 clinical trial is the stage at which a new drug is tested for efficacy and adverse reactions on a group of volunteers ranging in size from 300 to 3,000.

The Phases of a Clinical Trial

• Phase 1 – Testing the safety and dosage of a new drug, the first phase of a clinical trial is conducted on a pool of 20 to 100 volunteers over the course of several months. Approximately 70% of drugs move on to Phase 2.
• Phase 2 – Conducted over the course of a few months up to a few years, Phase 2 of a clinical trial is meant to test the efficacy and side effects of a new drug on a group ranging from 100 to several hundred people.
• Phase 3 – Phase 3 clinical trials are conducted on 300 to 3,000 volunteers over the course of one to four years. This stage continues to test for the efficacy of a new drug while monitoring for adverse reactions.
• Phase 4 – In the final phase, several thousand volunteers undergo clinical trials to further test for the safety and efficacy of the medicine.

Phase 3 Clinical Trial – Efficacy and Monitoring Adverse Reactions

With a length of one to four years, a Phase 3 clinical trial is more likely to show researchers long-term or rare side effects to a medication. This is the phase in which most of the safety data about the new drug is gathered, as it’s possible that less-common side effects have failed to be detected in earlier, shorter phases of the clinical trial up to this point.

Phase 3 clinical trials are designed by researchers to show whether or not a product is a beneficial treatment to a specific population of people. Only 25-30% of drugs move on to Phase 4.

Designing a Phase 3 Clinical Trial

At Oakwood Labs, we have extensive experience in producing global clinical trial material for Phase 1, 2, and 3 clinical trials. Through our Microbiology and Chemistry groups, we offer full characterization capabilities – proper documentation of batch release and accelerated and long-term stability studies.

As our team makes progress in development, the process will be validated. Multiple lots of API and polymer are used in the Phase 3 clinical trial process to demonstrate the product. We recommend conducting Phase 3 clinical trials on the same scale as intended for commercial scale to avoid delays in commercialization if clinical trials are successful.

Ensure Quality in All Phases of Clinical Trials with Oakwood Labs

Our team utilizes a continuous flow process in the scale-up process of your drug – we run the process longer and control the downstream processing so that the product is not changed over the course of the run. Additionally, we validate the scale-up process prior to the manufacture of clinical trial materials, and we use Quality by Design (QbD) principles and develop specific Design of Experiments (DoE) to increase the scale-up success.

From scale-up to Phases 1, 2, and 3, our team has the right combination of knowledge and expertise to guide you through the process of a clinical trial.

Contact Us for Your Phase 3 Clinical Trials

We are proud to be your source for all phases of long-acting injectable (LAI) development. With over two decades of drug encapsulation experience, our team is here to work with you on your proof of concept, feasibility studies, clinical trial material, and FDA-approved commercial supply.

In need of guidance for your Phase 3 clinical trial? Contact our team today!