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When caring for patients, it is critical to use medical treatments that are not only effective but also seamlessly incorporate into their lifestyles. With the risks associated with pills and the need for a regular routine, medical personnel often will turn to long-acting injectable antipsychotics for patient treatment due to the approach’s benefits.
Long-acting injectable antipsychotic drugs are commonly used for patients who experience unpleasant adverse side effects of antipsychotic drugs and are hesitant to believe they have a mental illness. While this form of medicine does not require the daily administration that other antipsychotics do, they are able produce relief to patients in need.
Administering Long-Acting Injectable Antipsychotics
Long-acting injectable antipsychotics can be utilized with diverse medications, making them ideal for patients suffering from an assortment of issues. Along with this, long-acting injectable antipsychotics are often administered in two-, three- or four-week intervals, but treatments can vary based on the patient’s needs. Time between injections also differs based upon the administered drug and its ability to stay within the system.
Candidates for this treatment often include patients with a history of non-adherence, severe symptoms, comorbid substance abuse, and cognitive impairment. Additionally, this method is extremely beneficial to patients who experience ambivalence or negative attitudes toward medications.
Why Long-Acting Injectable Antipsychotics Are Ideal for Patients
There are many advantages to using long-acting injectable antipsychotics on eligible individuals, as they can improve the lives and routines of patients in the following ways:
- Reduced accountability – In order for medications to work best, it is important for patients to take them every day according to instructions. Since long-acting injectable antipsychotics stay in the system for extended periods of time, they reduce the need for a daily reminder to take the drug.
- Regularity – By using long-acting injectable antipsychotics, the need for medical appointments increases. This creates regular interactions between the patient and medical staff, creating a more comfortable environment, providing more social interactions, and solidifying a routine.
- Stability – The long-acting injectable method treats patients with more stable plasma concentrations than oral medications. It also lessens the frequency of having peak plasma levels, which can result in fewer side effects for the patient. Lastly, it reduces relapse frequency and rehospitalization rates, making it a great alternative for those who are prone to hospital visits already.
- Safety – Since long-acting injectable antipsychotic drugs are administered by medical personnel, they are safer for patients. The approach reduces the risk of accidental or deliberate overdose through the use of regulated injections that work gradually over time.
Oakwood Labs Is Ready to Help You Produce Long-Acting Injectable Antipsychotics and More
Oakwood Labs is a leading manufacturer of sustained-release pharmaceuticals with over 20 years of drug encapsulation experience. We offer support throughout the phases of long-acting injectable development, ultimately achieving a product that provides enhanced therapeutic benefits to patients everywhere.
In our facilities, we can provide the following to help achieve your project goals, including those involving long-acting injectable antipsychotics:
- 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 injectable antipsychotics are a way to steadily prevent the intense symptoms associated with mental illnesses. Using this approach has the ability to put patients on the path to a stable and successful life.
The team at Oakwood Labs is ready to help with the development of your long-acting injectable antipsychotic drugs. Please reach out today and get started on your project with us!
The goal of clinical trials is to identify whether a designated treatment will benefit an identified population. This process applies to brand-new treatments that develop as well as treatments that were developed with the intention of replacing an older, less effective one.
From start to finish, the process of developing medicine is conducted methodically. Once your formulation has been scaled up and is ready to be tested on the intended human population, it is time to move on in the process to Phase 1 and Phase 2 clinical trials.
Phase 1 Clinical Trials
During a Phase 1 clinical trial, the goal is ultimately to evaluate the safety of a drug. It is often started with a smaller sample of healthy individuals who volunteer to be tested on. This gives insight into how the drug will impact the overall population and sparks research questions for Phase 2 clinical trials.
The Process
In the process of Phase 1 clinical trials, the group is first injected with a small dose of the medicine and monitored. Often, researchers are looking for severe side effects, since this is the first time the drug is being tested on the intended population. It is also common to look for the amount of a drug that is in the blood after administration and the overall effects of the drug on the body.
Researchers may also look for the side effects associated with increasing the dosage of the drug. This is helpful in determining the maximum dosage of the drug that can be administered without side effects. After notes are taken, they are evaluated and researched before moving onto Phase 2 of a clinical trial.
Phase 2 Clinical Trials
In a Phase 2 clinical trial, the goal is to perfect the dosage and test its effectiveness. Ultimately, this equates to the idea of maximizing benefits while minimizing risks to the user. In this step, the medicine is rigorously tested for its success in treating, preventing, or diagnosing a problem or disease.
The Process
During Phase 2 clinical trials, it is typical to test a much larger sample to better understand the drug’s effectiveness. Phase 2 can be thought of as comprising two halves. The first half focuses on dosing, where patients are given different amounts of the drug. It is important to carefully monitor changes when administering different doses. The second half of the trial is reserved for testing the efficacy of the drug.
After these steps are completed, the drug is then evaluated for its benefits and risks. Should the benefits outweigh the risks of the drug, the testing moves on to Phase 3 clinical trials for further assessment.
Choose Oakwood Labs as Your Clinical Trial Destination
Your Phase 1 and 2 clinical trials are critical to providing the public with effective medicine. The testing that needs to be conducted to make sure drugs are safe and effective for patients is extensive. When you discover a new drug that you want to take to market, it is important to be supported by a team that is both knowledgeable and experienced.
Oakwood Labs has the environment and qualified team needed to assist in the development of your treatment. Since 1997, our team has been providing therapeutic benefits to patients through the use of sustained-release pharmaceutical injectables. We operate in a fully FDA-compliant aseptic manufacturing facility to enhance our development capabilities and range of services.
Additionally, we have the ability to help with other projects. We offer the following services, making us the source for supporting all phases of long-acting injectable development:
- Feasibility studies
- Analytical development
- Scale-up capabilities
- GMP clinical trial material
- GMP contract manufacturing
Choose Oakwood Labs as Your Clinical Trial Destination
Oakwood Labs is equipped with the supplies, team, and facilities to help you plan and execute Phase 1 and 2 clinical trials. Contact us today to get started on your next project.
With over 20 years of experience developing time-release pharmaceuticals, Oakwood Labs is a trusted industry source for pharmaceutical products that include PLA and PLGA microspheres. PLGA and PLA polymers are FDA-approved biodegradable and biocompatible polymers that have been used in medical devices, including microspheres.
PLA Microspheres vs. PLGA Microspheres
PLA and PLGA microspheres are widely studied polymers in the medical field, as they allow for the encapsulation of the desired active pharmaceutical ingredient or drug. The PLA microspheres aide in controlling the release of the drug from the polymer matrix and allow for a sustained release of the drug over a period of time that can vary from weeks to several months.
PLA microspheres exhibit asymmetric centers in their backbone which result in either D or L forms, producing PDLA or PLLA. PLGA is the copolymer of D, L-lactic acid with glycolic acid.
While both PLA and PLGA microspheres are insoluble in water, their absorption of water causes them to degrade over time. The methyl groups of PLA microspheres decrease the water uptake properties of the polymer, thereby extending its time-release properties.
One of the most important factors that affects the degradation rate of PLA and PLGA microspheres is the molecular weight of the polymer. Crystalline parts of the polymer exhibit more resistance to degradation. As Keles states, “the crystallinity of the polymer depends on compositions. For example, increasing the percentage of glycolide monomer in PLGA backbones decrease polymer crystallinity.”
PLA and PLGA Microspheres Play a Critical Role
One advantage of working with PLGA and PLA microspheres is the fact that the polymers can be used to encapsulate almost all types of drugs. This includes:
- Small molecules
- Peptides
- Polypeptides
- Proteins
It’s possible for the microspheres to have such diverse abilities because they come in a variety of comonomer ratios, molecular weights, and end-capping configurations. This allows the release duration to be tailored for each specific drug. In addition, the release profile, such as the burst release, can be modified by choosing the appropriate polymer for the reaction.
The release profile of the drug over time is dependent on the specific drug that is being encapsulated by the PLA and PLGA microspheres. Interactions between the polymers and the drug can be positive or adverse and require an in-depth understanding to develop a successful microsphere product.
Our Process of Developing PLGA and PLA Microspheres
In initial production stages, we utilize small batches to allow for testing of a multitude of trial batches and rapid production. As we develop the formulation with the desired time-release profile and additional desired characteristics, we then refine methods of production. Our processing of developing PLA and PLGA microspheres starts in small batches to ensure that all desired properties are met and can then be scaled to a commercial production process.
Our Chroniject™ PLA/PLGA microsphere time-release injections are a leader in the industry and have several key benefits. Some of the benefits include:
- Rapid development of formulations with small-scale batches that are easily scalable
- Proven lot-to-lot reproducibility
- Flexible release durations that vary from one week to one year
- Applications in multiple therapeutic indications (CNS, neurology, ophthalmology)
Contact Us for Your PLA/PLGA Microsphere Needs
Oakwood Labs is equipped to support all development phases of time-release drugs using our PLA/PLGA microsphere technology. If you are interested in knowing more about how our microspheres can help you, contact our team today.
This year’s PDA Annual Meeting is occurring April 4-6 in Dallas, TX. This event is focused on the theme of “Level Up: Agility in the New Normal” and will highlight items to look forward to in the future of pharmaceutical manufacturing.
Incorporating speakers, networking events, and panel discussions, this is an event that you will not want to miss. This year, we are excited to announce that we will be featured as an exhibitor.
We Look Forward to Seeing You
Our team has been focused on researching and developing sustained-release injectables, and we are always looking for opportunities to chat about our discoveries and processes. If you are looking for an aseptic lab staffed by experts, consider Oakwood Labs for your next project, as we can assist you in the following:
- Pre-formulation development activities
- Feasibility studies
- Scale-up of formulation
- Manufacturing toxicology batches
- ICH compliant stability testing
- Clinical trial manufacturing (Phase I, II, III)
- Commercial aseptic GMP manufacturing
We are so excited to meet you and show you what we have been working on, so be sure to come to visit the Oakwood Labs team at Booth #308.
Don’t Hesitate to Reach Out
The 2022 PDA Annual Meeting is sure to inform us about new trends and inspire us to be innovative as we take on the pharmaceutical challenges that lie ahead. If you are unable to attend the event, we would be happy to chat about our experience at the occasion or provide information on extended-release technology and more.
Reach out today with any questions you may have. We look forward to seeing you soon!