Best known for their versatile role in a vast array of chemical applications, organic solvents play a crucial role in numerous sectors, including the medical industry.

To gain a better understanding of how these solvents can contribute to pharmaceutical practices and manufacturing techniques for drug delivery, review our complete guide for more information.

An Overview of Organic Solvents

As industry experts are aware, organic solvents are solvents that contain carbon atoms capable of either dispersing or dissolving one or more substances. Due to their chemical makeup, these solvents can be utilized in a variety of industries, such as textiles, cleaning, agriculture, and pharmaceuticals.

Additionally, common characteristics and properties of suitable organic solvents include the following:

• High volatility
• Acid-based properties
• Low boiling point
• Suitable density

As opposed to some inorganic solvents, organic solvents can also be described as combustible and extremely flammable. That’s why we advise that those looking to work with organic solvents in long-acting injectables, or processes such as spinning and dyeing textiles, ensure that they are handling these carbon-based solvents with the utmost care.

The Role of Organic Solvents in Long-Acting Injectables

Organic solvents in pharmaceuticals, such as long-lasting injectables, can contribute to an expansive array of roles throughout the drug delivery process, such as the following:

• Dissolving drugs at high concentrations – Organic solvents can be utilized to dissolve drugs, such as biologics, that otherwise have a higher concentration and a lower aqueous solubility. That way, long-acting injectables can be administered at the appropriate viscosity and form drug depots under the skin’s surface.

• Forming drug depots – Drug depots, or depot injections, are longer-duration drugs that result in a slow absorption into the bloodstream. Though organic solvents can contribute to the formation of these drug depots, the administration of the drug into your muscle is best when using a depot.

• Determining the rate of release – Once the drug depot has formed, organic solvents decelerate the rate of their delivery, resulting in a more gradual, sustainable release and absorption of the medication over time.

A Look at Organic Solvents in Pharmaceuticals: Their Industry Uses and Beyond

Along with their inherent contribution to the production of long-lasting injectables, organic solvents in pharmaceuticals play many key roles in the total industry. Beyond mainly being utilized as reaction media, organic solvents are used in the following processes:

• The purification of synthesis products
• Excipients, such as coloring agents, preservatives, and fillers
• The bioavailability of orally administered protein-active sites
• Semiempirical models of meditated solubility
• Antisolvent crystallization techniques in pharmaceutics

Additionally, organic solvents can even be used in water-based cleaning solutions. This is because they are capable of penetrating oily soil deposits while also dissolving in water.

FAQs About Organic Solvents, Their Capabilities, and More

What are the most common organic solvents used in pharmaceutical manufacturing?

The most common applications when working with organic solvents in pharmaceuticals include the following:

What safety precautions should be taken when working with organic solvents in pharmaceuticals?

As stated previously, organic solvents can be extremely flammable and volatile, so handling them with care is essential. With that in mind, here are some stringent safety regulations you should abide by during the manufacturing process:

• Gloves and safety glasses should be worn when handling the materials
• A fume-hood is required when pouring out organic solvents
• Spill kits and eyewash stations should be readily available in the workspace
• Flammable liquids, such as bleach, peroxides, and acids, should be stored away from organic solvents

Can organic solvents be reused or recycled?

Yes, organic solvents can be recycled easily and reused in syntheses. This includes collected solvents that are separated by distillation and have different boiling points.

Contact Oakwood Labs for More Information

As your trusted resource for sustained-release injectables and other services, Oakwood Labs is well-equipped with the necessary tools to satisfy your application needs.

For more information about organic solvents in pharmaceuticals, long-acting injectables, and more, please reach out to our team today. We look forward to assisting you.

Long-acting injectables are favored in the medical field due to their effectiveness and convenience, as their injection methodology allows for the gradual release of medication into the bloodstream. In post-operative care, the alleviation of pain is vital not only for recovery, but for the comfort of the patient. With the help of long-acting injectable drugs for post-surgical pain management, patients can experience a more effective recovery.

The History of Long-Acting Injectables

Long-acting injectable drugs were first introduced as a treatment for people with chronic schizophrenia. These long-acting injectable antipsychotic drugs were created as an effort to solve the issue of poor adherence to oral medications. Some notable points in the history of long-acting injectables include the following:

• 1950s – 1970s – Long-acting injectables were created to help manage conditions such as schizophrenia. In 1952, chlorpromazine (CPZ) was developed in Paris, offering an effectiveness greater than that of older drugs on the market. Then in 1966, thanks to G.R. Daniels, a medical director at the time, the first long-acting injectable was created. This first injectable was AP fluphenazine enanthate, with fluphenazine decanoate being created just eighteen months later.
• 1980s – 1990s – During this time, long-acting injectables for second-generation antipsychotics were introduced. Between 1988 and 1992, Risperidone was first developed by Janssen-Cilag. Its purpose was to treat behavior issues in children and adolescents.
• 2000s – present – Long-acting injectables have come a long way since their creation. With their medication methodology, they can provide better adherence to timelines, facilitate proper dosing, and free patients from having to take oral medications every day. With continuing research on long-acting injectables, we are seeing uses in areas such as contraception, chronic and acute pain, antiretroviral therapy, and more.

The Role of Long-Acting Injectables for Post-Surgical Pain Management

A key factor of post-surgical work is minimizing patient pain, giving them the time they need to heal. With the use of extended-release drugs for post-surgical pain management, doctors are better able to effectively manage pain for their patients and promote an expedited recovery process.

Types of Injectables Used for Post-Surgery

NSAIDs, or nonsteroidal anti-inflammatory drugs, are medications that reduce fever, pain, and inflammation. Looking at postoperative care, NSAIDs help in mitigating pain, minimizing the reliance on opioids, and fostering a healing environment. You may be familiar with some over-the-counter NSAIDs such as ibuprofen or aspirin.

NSAIDs are known to prevent blood from clotting, which can definitely be beneficial in post-surgery situations. In cases such as orthopedic procedures that involve prolonged immobility, there is an increased risk of blood clot formation. NSAIDs help prevent that blood clotting, specifically in the veins.

Some common NSAIDs that have been used as long-acting injectables for post-surgery pain management include:

• Toradol (Ketorolac) – This NSAID is used to relive pain and is commonly available in injection or tablet form. The injections work about thirty minutes after administration and the effects can last up to six hours. Often prescribed for post-surgery pain, it typically is distributed as a one-time injection. However, some people may receive a shot every six hours. This will depend on factors such as body weight, age, drug interactions, and others.
• Diclofenac sodium – This medication is another NSAID used to treat adults with mild to moderate pain. It can be used for osteoarthritis, low back pain and for post-operative patients. Similar to Toradol, the effects may start to work immediately after the injection.
• Caldor – This ibuprofen injection works by reducing fever and treating pain in the body. It helps manage pain as an adjunct to opioid analgesics.
• Ketoprofen – Ketoprofen can help with acute and chronic pain, both for the traumatic and rheumatic origin. Additionally, it can help alleviate postoperative pain, specifically in the orthopedic field. While ketoprofen is offered as an injectable, that is not the intended use for humans. There is an oral tablet for humans, only available with a doctor’s prescription. The injectable form is actually intended for animals, such as horses. In horses, it’s used for musculoskeletal pain or inflammation, abdominal pain, and other inflammatory conditions. It can also be used effectively for cattle, goats, sheep, and pigs.

The Capabilities of Oakwood Labs

At Oakwood Labs, we are a leading developer of sustained-release pharmaceuticals and have over 20 years of experience in drug encapsulation. We are here to offer support throughout the development of different types of long-acting injectables.

Our facilities can provide the following to help you achieve your project goals:

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

Contact Us to Learn More

With our history of compliance and commitment to quality, we continue to be a leader in injectable pharmaceutical development. If you’re wanting to learn more about injectable development or our other capabilities, contact us today.

Knee pain is a common issue for adults because it is caused by general stress from normal daily activities. In fact, around 25% of U.S. adults experience knee pain, and many of them require treatment to make day-to-day activities easier.

Long-acting injectables are able to target specific anatomical areas like eyes, ears, knees, and other spots to relieve pain and reduce systemic exposure. This means they are capable of providing a means of comfort for patients experiencing problems like osteoarthritis, rheumatoid arthritis, bursitis, or tendonitis. Learn more about the benefits of extended-release drugs for knee pain and how you can help patients by manufacturing them.

Benefits of Using Extended-Release Drugs for Knee Pain

Extended-release drugs and long-acting injectables for knee pain are designed to release the active ingredient over time. These medications encourage the maintenance of the therapeutic levels in the body for an extended time period and provide prolonged pain relief. The outcome of prolonged pain relief is less frequent dosages and happier patients.

Other benefits of using these types of medication include:

• Reduced side effects – Extended-release drugs encourage lower overall doses when compared to the immediate-release competition. This can lead to fewer side effects, as the patient will be exposed to a lower peak concentration of the drug.
• Improved patient adherence – Since these types of drugs require less frequent doses, patients are more likely to adhere to their prescribed regimen. This can lead to better pain management outcomes, making them the go-to choice for more patients.
• Minimized fluctuations in pain levels – When patients are given immediate-release formulations they may experience highs and lows from the drug concentration that leave them with fluctuations in the extremity of their knee pain. Using extended-release medications for knee pain limits this issue by providing a consistent and controlled release.

Types of Extended-Release Drugs for Knee Pain

There are currently two main types of extended-release injectable drugs for knee pain. The type that is administered will depend on the patient’s problem, pre-existing health conditions, and more.

Corticosteroid Injections

Corticosteroid injections reduce pain and inflammation in the knee joint, thanks to their powerful anti-inflammatory agents. These synthetic drugs mimic the effects of natural hormones produced by adrenal glands. The relief is often found quickly, with many patients experiencing reduced pain in just a few days. The relief should last around three to four months, depending on the patient and the severity of their condition.

A prominent example of a corticosteroid long-acting injectable for knee pain is inserting Triamcinolone LAI in the knee. Another common type is ZILRETTA®.

Hyaluronic Acid Injections

Another type of long-acting injectable drug for knee pain is hyaluronic acid injections. Known for their ability to replenish knee lining and reduce friction on the joints, hyaluronic acid injections are an extremely effective treatment for those fighting osteoarthritis. These injections also protect the cartilage and bone from further damage, relieving pain effectively. While they may not have the longevity of a typical long-acting injectable drug for knee pain, they will provide patient relief for between two and six months.

Hyaluronic knee injections currently on the market include Durolane, Euflexxa, Hyalgan, Monovisc, and more.

Using Best Practices When Manufacturing Long-Acting Injectables for Knee Pain

Adhering to best practices when producing long-acting injectable drugs for knee pain is essential, and it’s something the team at Oakwood Labs is committed to. Doing so assures your patients that the solution was created using rigorous processes and that the medication is safe.

Let’s discuss some of the best practices for creating extended-release drugs for knee pain and how Oakwood Labs can provide.

• Conduct clinical research and development – The process starts with conducting pre-clinical studies to assess feasibility, safety, and efficacy. Then, it is time to study the population to create the intended patient demographic, as well as execute clinical trials to ensure that the solution is relevant to the problem and population.
• Create optimal formula – The next step is to research and develop a formulation that will provide sustained and effective pain relief without complications or introducing new side effects. Be sure to check this over time and ensure that the extended-release drug for knee pain will continue to provide the most benefits to the patient.
• Determine dosing and administration – Based on clinical research results, you will want to determine an appropriate dosage and administration schedule. Then, create clear and concise instructions for proper administration for patient safety and reduced risk.
• Assess safety – Once you develop the proper instructions for administering the long-acting injectable for knee pain, it is important to conduct comprehensive safety assessments that define adverse effects, drug interactions, and any risks. Then, be sure to monitor unexpected side effects during post-marketing surveillance.
• Provide education and training – Collect comprehensive educational materials that healthcare professionals and patients can look at to ensure the best understanding of the long-acting injectable for knee pain as well as any side effects.
• Adhere to ethics – Ethics are a priority in pharmaceutical manufacturing, covering everything from reporting results to ensuring equal access. Be sure to adhere to ethical standards in all aspects of development.
• Choose a GMP manufacturer – Oakwood Labs operates in an FDA-approved cGMP manufacturing facility that is capable of conducting Phase I, II, and III clinical materials, delivering commercial products, and more. We also have decades of industry experience, making us the ideal destination for manufacturing long-acting injectables for knee pain. As your partner, we can offer short lead times, robust systems, CMC development capabilities, and so much more.

Contact Us to Learn More

If you are interested in manufacturing extended-release drugs for knee pain, Oakwood Labs would be happy to partner with you.

Contact us today to get started.

When it comes to drug creation and formulation, ensuring that both the creator and the property are protected is key. That is why it is important to understand what your intellectual property rights are, and how to defend them even after FDA review and distribution.

With that in mind, check out our informational guide on intellectual property protection, and how it applies to the pharmaceutical industry.

An Overview of Intellectual Property Protection

Intellectual property protection was established to legally safeguard ideas and inventions of the mind. This includes original pieces of work, such as artistic creations, symbols, names, manufacturing processes, pharmaceutical formulas, and beyond.

Intellectual property also comes in various forms depending on the medium of the work. The main types that you should be familiar with relate to the following:

Why Is Intellectual Property Protection Vital in the Pharmaceutical Industry?

The protection of intellectual property in the pharmaceutical industry allows pharmaceutical creators to benefit fiscally from both idea fabrication and product manufacturing. Additionally, some of the reasons that intellectual property is legally protected and closely monitored include the following:

• Promotes continuous innovation – Since patents and other intellectual property types provide outside investors with the motive to put money into the research phase of drug creation, pharmaceutical scientists can continually work on evolving existing developments. Along with manufacturing and distributing current drugs, scientists can also create new drugs and start desired projects while knowing that their progression is being fully supported financially.
• Increases economic growth – Due to the ongoing process and competition that comes with bringing new drugs to the market, the creation of pharmaceuticals can produce further economic opportunities, such as generating new jobs and boosting overall exports on a global scale.
• Prevents misuse and confusion – With intellectual property protection, the rights to the formula and branding of a product belong solely to the company or individual who created it. That means consumers will know exactly who and where the product has come from, as well as what the intention of the specific product is. This will avoid misuse of the product itself, as well as confusion about the specifications of the product.

Overall, the protection of intellectual property increases innovative initiatives for companies looking to cultivate and expand upon drug development ideas and procedures. Alongside the developmental period for pharmaceuticals, intellectual property measures also legally protect creators from property infringement by competitors, ultimately boosting the production, distribution, and consumption of necessary medications.

A Brief History of Pharmaceutical Intellectual Property Protection

When it comes to protecting the creation of new drugs, applications, and research, intellectual property protection is crucial. The origins of intellectual property are not new ideas either, as the first instances of intellectual property disputes and one-year patent statements date back as far as 500 B.C.E.

In the modern era, there have been numerous cases that have shaped how we navigate property ownership and distribution. Alongside those cases, here are just some of the notable historical events that have progressed intellectual property rights:

• 1928 – Alexander Fleming discovered penicillin at St. Mary’s Hospital in London. This discovery marked the beginning of the antibiotic age, which lasted until around 1970, with 1940 to the early 1960s being considered the true golden age of the antibiotic era. During this time as well, product patents for drugs became more prevalent as growth and expansion prospered, though global drug patents were first introduced for the pharmaceutical industry in the late 17th century.
• 1984 – The Hatch-Waxman Act was established in the United States, laying the foundation both legally and economically for the U.S.’s generic pharmaceutical industry. And as more countries, such as Canada, began to recognize the importance of drug patents as well, multinational corporations (MNCs) within the pharmaceutical industry started to advocate on a global level for stronger intellectual property protection and patent laws for their products.
• 1994 – The TRIPS Agreement was established in this year and set minimum enforceable standards for various forms of intellectual property across numerous industries. For the pharmaceutical industry, it required countries part of the World Trade Organization (WTO) to make patents available for any products or processes without discrimination, completely replacing the “process patent” system that was in place at the time.
• 2000 onward – Patent thickets, evergreening, and consolidation practices become highly common in the pharmaceutical industry. Also during this time, we saw large lobbying efforts in the United States to try to prevent price controls from stopping skyrocketing prices on necessary drugs. This includes key bills, such as The Inflation Reduction Act of 2022.

FAQs – Additional Aspects to Consider

For more of an in-depth look at intellectual property protection and how to navigate the main types, check out the answers to some of our most commonly asked questions.

How long do patents last on new drugs?

As of this writing, patents last 20 years from the filing date listed on the patent application. Once a drug patent expires, manufacturers other than the original developer have the freedom to produce generic versions of the product. These drugs are usually clinically equivalent to the original.

Can generic drugs have the same trade name as the original drug?

No. Though the chemical composition may be almost exactly alike, trademarks protect the original brand name, and generic brands must accommodate these regulations to avoid consumer confusion.

Does intellectual property protection increase drug prices?

Yes, it can potentially lead to an increase in drug prices. This is because patent exclusivity both delays cheaper versions of a drug from being made, as well as allows drug companies to have complete control over the pricing of their products.

How are manufacturing processes and drug formulas protected today?

One of the key ways drug formulas and their processes are protected is via trade secrets, which provide companies with a competitive advantage. These secrets do not need to be registered and can be protected for an unlimited amount of time, though there are some conditions for protection, including the following:

• The information must not be known to the general public
• The formula or process must have commercial value to be secret
• Reasonable steps must be taken by the information holder to keep it secret

Contact Oakwood Labs Today to Learn More

Have any additional questions? If so, reach out to our team at Oakwood Labs today. We look forward to answering your questions or discussing our services with you.

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.