Amino acids have proven their capabilities in the pharmaceutical industry in a variety of ways. They can be used alone as nutritional supplements, synthesized to help form other products, or even built into drug delivery systems.

Since Oakwood Labs focuses on drug formulation, we wanted to explain the role of amino acids in pharmaceuticals, specifically addressing how they impact sustained-release injectables and provide therapeutic benefits to patients.

How Amino Acids Benefit Your Pharmaceutical Projects

Amino acids are used in the development and function of sustained-release injectables and pharmaceuticals because they help with matrix formulation, suspension, drug diffusion, and biocompatibility.

Different amino acids and combinations can be deployed to achieve specific therapeutic goals. With this in mind, the amino acids used will depend on factors like the drug that is being delivered, the intended release kinetics, and the compatibility of the overall formation.

Using amino acids in pharmaceuticals like sustained-release injectables assist with the following:

• Matrix formulation – The use of amino acids in sustained-release injectables can help form a matrix that is modified to perform long-acting therapy for the patient. The matrix encapsulates the active drug and helps control the rate at which it is released, making it ideal for less frequent doses and better patient compliance.
• Solubility – Solubility is needed in drug formulations because it leads to effective absorption. By enhancing the solubility of certain drugs, amino acids better maintain the composition of the drug and promote absorption into the body.
• Stability – Along with solubility, amino acids also protect the drug from degradation throughout the process of storage and release. Stabilization additionally helps increase drug effectiveness, especially when dealing with sustained-release applications.
• Modulation – Using amino acids in a sustained-release application can adjust the overall drug output to meet the demands of the patient. This means amino acids are capable of altering the diffusion characteristics of the drug being used within the formulation to better meet a patient’s therapeutic objectives.
• Biocompatibility – Amino acids used in pharmaceutical applications like sustained-release injectables can promote biocompatibility for medical applications. Biocompatibility means that the injectable will not interfere with any of the other cellular functions or compromise the patient’s wellness, and it is important because it increases safety, long-term tolerability, and regulatory compliance.

Benefits of Using Sustained-Release Pharmaceuticals

Sustained-release injectables and pharmaceuticals have gained popularity in recent years due to their variety of benefits. Since the drug remains active in the bloodstream over a period of time, sustained-release dosages offer prolonged therapeutic effects. This helps improve patient compliance and reduce the frequency of dosing.

Other advantages of sustained-release dosages include:

• Prolonged action of the medicaments
• Control over drug therapy
• Ability to modify the extent and rate of drug absorption
• Delivering API directly to the desired location
• Decreasing total amount of a drug, reducing local side effects
• Ability to modify the extent and rate of drug absorption

Work with Oakwood Labs on Your Next Project

If you are looking to incorporate amino acids into your pharmaceuticals, be sure to request help from the team at Oakwood Labs. We are a leading manufacturer of sustained-release pharmaceuticals and will work with you throughout the creation process. This includes proof of concept, feasibility studies, clinical trials, and finally the production of an FDA-approved commercial supply.

Additionally, our team has over 20 years of experience, which makes us a trusted and effective partner for global pharmaceutical firms of all sizes. See how we can incorporate amino acids into your sustained-release pharmaceuticals and beyond today.

Learn More About Using Amino Acids in Pharmaceuticals

The team at Oakwood Labs is ready to help you achieve high-quality results in your next project. Our quality assurance and validation practices will deliver the best solutions, regardless of the formulation needed.

For more information on using amino acids in sustained-release pharmaceuticals, be sure to contact us today.

As you know, Oakwood Labs is a global leader in sustained release injectable pharmaceuticals. One of the key components of these drugs are microparticles, which are delivery systems for water-insoluble and sparingly water-soluble agents. Microparticles are split into microspheres and microcapsules.

Both of these play an important role in the pharmaceutical development process at Oakwood Labs. Learn more about microspheres vs. microcapsules.

What Are Microspheres?

Microspheres are small spherical particles that have a solid outer casing, are hollow, and do not contain fluid inside. These particles are made out of polymers and are used in drug delivery applications due to the high surface area, but low particle size. Their size ranges from 1 μm to 1 mm, making them effective for traveling within different areas throughout the body, which helps increase absorption rate and bioavailability.

Microspheres can be delivered through oral, parenteral, nasal, ophthalmic, and transdermal methods. They attach to proteins, peptides, antibodies, antigens and other small molecules to travel through the body and release at controlled rates.

Using microspheres in drug delivery has many benefits including release rates are tailored to specific applications (constant rate of delivery or rapid release), an increase in patient comfort and compliance by reducing the dosing frequency, and more.

What Are Microcapsules?

A microcapsule is also a small spherical particle, but its size is a little different, being 50 nm to 2 mm. The structure of a microcapsule is that of a membrane-enclosed core with a shell-like coating. Sometimes there are multiple cores within the coating. The core is composed of a drug constituent, stabilizers, or additives. The outside coating consists of an inert polymer, coloring agent, plasticizers, resins, waxes and lipids.

Microcapsules allow the core to be isolated from the outside environment and then released when desired. These microcapsules are used for sustained drug release, converting liquid drugs in a free-flowing powder, reducing toxicity and GI irritation, and for drugs that are sensitive to oxygen, moisture or light.

The Key Differences Between Microspheres and Microcapsules

The major difference between microspheres vs. microcapsules is the structure of the particle. As mentioned previously, microspheres have a solid casing and are hollow, while a microcapsule has a solid or liquid core in a shell-like coating.

The main reason for microencapsulation in pharmaceuticals is to protect drugs from environmental hazards like humidity, light, oxygen or heat. They also help controlled release within the patient and avoid too rapid of a release.

Microspheres are manufactured out of different types of polymers that when injected react within the patient to release a certain amount of the drug. While microspheres and microcapsules achieve similar goals for controlled drug release, their structures are what sets them apart.

Our Process for Manufacturing Microsphere Technology

At Oakwood Labs, our microsphere manufacturing capabilities have solved complex pharmaceutical industry challenges for more than 20 years. Our microsphere technology Chroniject™ is a patented, polymer-based injectable microsphere system for drug delivery. This technology is unmatched, and some of its major benefits include:

• Use of small-scale batches allow for rapidly developed formulations
• Formulations are easily scalable
• Process parameters are well-controlled
• Compatibility with peptides, small molecules, and proteins
• Excellent stability
• Flexible release durations ranging from one week to one year

Reach Out Today for More Information on Microcapsules and Microspheres

Our team is fully equipped and operates a staffed research and development facility specifically created to manufacture sustained release injectables. Oakwood Labs is committed to developing products to provide therapeutic benefits to patients.

If you are interested in learning more about microspheres vs. microcapsules for drug delivery, contact us at Oakwood Labs today.

Medications are classified and categorized in many ways including when it comes to distribution methods, dosage, intent, and more. For the purposes of this post, we are going to focus on the rate at which medications are released in the body to serve their intended function.

The time it takes for a drug to run its course will impact all of the characteristics mentioned above, so we’ll look at extended-release medication and modified-release medication and how it applies to drug delivery.

What Is the Difference Between Immediate-Release Drugs and Extended-Release Drugs?

Immediate-Release Drugs

For the purposes of comparison and to fully understand the role of extended-release medications, we’ll start by acknowledging the most common oral dosage for medication, which is immediate release. Any medications classified as immediate release, or IR, go to work very quickly and for a short period of time.

Modified-Release Drugs

As part of an effort to administer medications more conveniently and provide worthwhile options for patients, modified-release medications began appearing on the market. These medications were developed to extend and/or delay their effects to better aid the patient. Their design often means that a patient is required to take medication less frequently, which in many cases is majorly beneficial to their lifestyle.

Modified-release drugs, also known as extended-release drugs or slow-release drugs, are designed to last longer in your body. For example, someone administered an extended-release medication may only need to take one to two doses as opposed to three to four doses of an IR medication. From a physiological standpoint, these medications are absorbed much slower by the patient and do not start breaking down until they reach a certain area of the body.

What Purposes Do Slow-Release Drugs Serve and How Can Oakwood Labs Help?

As mentioned above, modified-release drugs require less frequent doses while still delivering the same medicinal benefits as their counterpart IR medications. This can be quite beneficial when it comes to an individual who has trouble taking medication on a set schedule or more than once a day.

One type of extend-release medication that is frequently used is long-acting injectables. Oakwood Labs is a leader in the development and manufacturing of these extended-release injectables, and some benefits of this type of drug administration include:

• Fewer injections needed over a determined period of time
• Ability to target precise areas of the body
• Improved patient compliance
• Help in preventing drug abuse

Our team has over 20 years of drug encapsulation experience and can work closely with you in developing long-acting injectables for your needs. Visit our homepage to learn about everything we can provide.

Contact Oakwood Labs for Extended-Release Medications

Oakwood Labs has been working in pharmaceutical development for over two decades and has a team of dedicated scientists ready to help your business from concept to finished product.

If you are interested in working with us or would like to learn more about slow-release medications, contact our team today!

Designed to work as a long, persistent, and rigorous process, drug development is crucial to progressing the field of medicine. Drug researchers and developers are tasked with expanding on previous information and findings in order to combat the rise of new, as well as prevalent, diseases.

Because of this, our team at Oakwood Labs wants to highlight the five drug development stages to further encapsulate the rigor of the process of providing sustained-released injectable pharmaceuticals for the community.

Drug Development Stages Broken Down

As addressed by the FDA, the stages of drug development follow a similar trend for each case. Because of this, we have outlined each drug development stage below, as we feel it is important for our clientele to have an inside look at the processes that we adhere to.

Discovery and Development

Known as the first stage of drug development, the discovery and development stage starts with an initial idea that is fabricated through consistent research and trends. During this stage, scientists discover new insights into the disease process, which allows them to develop a design for a product to either stop or reverse the effects of the disease under consideration. From there, several tests of the molecular compounds are tested to find the possible beneficial effects, or even test existing treatments that might possibly have unanticipated effects.

Once researchers find results of a promising compound through the discovery process, they conduct further experiments to gather information on the following hypotheses:

• How the promising compounds absorb, distribute, metabolize, and dispose of waste
• The mechanisms of action, and how they can be beneficial to further drug development
• The best dosage of the future drug
• The best way to give or take the drug, such as by mouth or as an injectable
• The side effects of the drugs, also known as toxicity
• How it affects individuals of different races, genders, and ethnicities differently
• How it correlates and interacts with other drugs and treatments
• Its overall effectiveness compared to similar treatments

After conducting the series of tests to gauge additional information, researchers are then ready to conduct the preclinical research stage of drug development.

Preclinical Research

As a precautionary measure, researchers must further test their drug for toxicity before distributing the finalized product for public use. Presented in the form of either in vitro or in vivo research, this stage of drug development must be conducted in favor of good laboratory practices (GLP), which can be found in 21 CFR Part 58.1: Good Laboratory Practice for Nonclinical Laboratory Studies. These regulations essentially set the minimum basic requirements for features, such as study conduct, personnel, facilities, equipment, written protocols, and operating procedures, among others.

Though preclinical studies are not usually large, they must provide very stringent and detailed information regarding dosing and overall toxicity levels. Once completed, researchers will assess their findings and decide whether the drug should proceed to the clinical research stage of drug development.

Clinical Research

During this drug development stage, the drug that was initially tested in the preclinical trial will now be tested on people with the hopes of finding how it will interact with the human body. But before the clinical trial can even start, developers will need to design the clinical study for the trial.

When designing a clinical trial, developers follow a specific study plan or protocol that is initially developed by the researcher or manufacturer. Then, the researchers will review the information from the previous two stages to develop research questions, objectives, and decide the following:

• A selection criterion of who qualifies to participate
• The number of people allotted for the study
• The duration of the study
• If there should be the presence of a control group to limit research bias
• How and at what dosage the drugs will be administered
• What assessments will be conducted and what data will be collected
• How the collected data will be reviewed and analyzed for future drug development stages

Unlike the preclinical trials, the clinical trials range from early, small-scale studies to late-stage, large-scale studies.

FDA Review

Considered the final drug development stage, the FDA review team will thoroughly examine the evidence from the drug’s early tests, preclinical and clinical research, and decide to either approve or not to approve the product.

During this stage, a New Drug Application (NDA) must be provided to outline the entirety of the drug development stages that lead to the anticipated approval. The NDA must include the following when presented:

• Proposed labeling
• Safety updates
• Drug abuse information
• Patent information
• Any data of studies that were not conducted within the United States
• Institutional review board compliance information
• Clear and concise directions for use

Finally, the drug is sent for approval to the FDA, where the committee decides whether the drug is safe and effective for public use. The process of approval can take anywhere from 6 to 10 months, as it goes through several inspectors, project managers, and pharmacologists.

From there, the drug is passed to the labeling and marketing stage, where the remaining issues will need to be resolved, and labeling will be provided accurately and objectively for public discretion.

FDA Post-Market Safety Monitoring

Though there are rigorous and persistent steps during each stage of drug development up to its approval and distribution, limitations are still evident and existent. Because of this, the FDA closely monitors drugs for months and even years so they can review the reports on the prescription and decide whether or not to add cautions to the dosage or usage information.

If there were significant changes that needed to be made to a product after the drug development stages were complete, developers would have to file a supplemental application in order to make those changes.

Why Choose Us for Your Pharmaceutical Needs

At Oakwood Labs, we are honored to provide sustained-released injectables to our extensive clientele. On top of that, some of the benefits of working with our pharmaceutical company through each stage of drug development include the following:

• Pre-formulation development
• Feasibility studies
• Scaling formulation
• Toxicology batch manufacturing
• ICH compliant stability tests
• Small-scale to large-scale clinical trial manufacturing
• Commercial and aseptic GMP manufacturing

Contact Oakwood Labs to Learn More About the Stages of Drug Development

If you have any specific questions regarding the drug development stages that Oakwood Labs conducts for sustained-release pharmaceuticals, please contact our team today. We look forward to assisting you in any way we can.

In order for injectables to be able to successfully provide sustained releases, they necessitate drug-encapsulating devices. For over 50 years, encapsulation has been one of the many techniques used in the pharmaceutical industry. In this process, medication is released from a microsphere by the drug detaching from the polymer or through the degradation of the polymer matrix.

Keep reading to learn more about the role of polymer microspheres in the process of drug delivery and how our technology can be an asset to your long-acting injectable project.

The Use of Polymer Microspheres in the Pharmaceutical Industry

Polymer microspheres are often used in drug delivery because they have a high surface area and low particle size, which increases their absorption rate and bioavailability. Since these microspheres are small in size, they are also efficient when moving throughout the body. They are additionally capable of sustained release, making them ideal for use in long-acting injectables for both passive and active targeting.

Capabilities of Microspheres

Microspheres can be organic or inorganic and are designed to encapsulate bioactive molecules and release them in a controlled way. They are used for desired release profiles and can be used to target specific delivery sites throughout the body, including organs.

Additionally, they are considered rigid which means that they can be packed together, found alone, or even combined with other biomaterials to create porous 3D-structured scaffolds. In these scaffolds, they can either serve as a component of a larger scaffold or be the building blocks of one.

Factoring in the Polymer

Polymers can take the role of bioactive or biodegradable depending on the agents they are combined with. When incorporated with therapeutics, polymers become bioactive and provide their own therapeutic benefit. However, they can also be biodegradable which improves release kinetics and helps prevent carrier accumulation.

The benefits of using polymers for encapsulation include the following:

• Ability to encapsulate a variety of drugs
• They have high biocompatibility
• They are bioavailable

Incorporating Chroniject^TM Technology into Your Project

Since polymer microspheres are suited for sustained-release technology, they are the perfect candidate for long-acting injectables. Our technology for microspheres is a patented, polymer-based injectable for drug delivery called Chroniject^TM. This technology is compatible with small molecules, peptides, and proteins. It is also capable of enabling sustained release over durations of two weeks to one year.

Our Chroniject^TM process for microsphere manufacturing initially uses small batch sizes to enable the production of numerous trial batches. This allows us to obtain a formation with the desired release profile and other indicated product characteristics. Additionally, this process can easily be scaled up to commercial production levels with lot-to-lot reproducibility. Since we can produce clinical trial material at the forecast commercial scale, scaling up is feasible at the commercial scale and is conducted in our GMP facility.

Advantages of Using Chroniject^TM

There are diverse advantages of using polymer microspheres and our Chroniject^TM technology for drug delivery, which include the following:

• Rapid development of formulations using small-scale batches
• Easily scaled formations
• Process parameters that are monitored and controlled
• Proven lot-to-lot reproducibility
• Molecule compatibility (small molecules, peptides, proteins)
• Flexible release durations, ranging from one week to one year
• Excellent stability
• Instant reconstitution with WFI – no special diluent required
• Applications in various therapeutic indications (CNS, neurology, ophthalmology)

About Oakwood Labs

Oakwood Labs is a specialty pharmaceutical company located near Cleveland, Ohio. We are focused on developing and manufacturing sustained-release injectable pharmaceuticals, incorporating our microsphere-based technology. We operate in a fully compliant, aseptic facility that is specifically used for manufacturing pharmaceutical products like injectables.

Our goal is to provide enhanced therapeutic benefits to patients while achieving excellent returns for our pharmaceutical partners. With over 20 years of experience, we have proven ourselves as an effective partner of global pharmaceutical firms. From proof of concept and feasibility studies to clinical trials and FDA-approved supplies, the team at Oakwood Labs is ready to help incorporate polymer microspheres into the development of long-acting injectables.

Contact Our Team with Any Questions

If you are interested in learning more about our capabilities in incorporating polymer microspheres into long-acting injectables, please reach out to our team today.