Archives by Month: July 2022
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!
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!