Contract Formulation Company Profile - Analytical Research Laboratories

Analytical Research Laboratories
Analytical Research Laboratories

Headquarters
Oklahoma City, Oklahoma

Location(s)
Oklahoma City, Oklahoma

Years in Drug Formulation
14 Years

Spokesperson
Dr. Nicole Vu, Scientific Director

Areas of research
•	Small Molecule			Biological			Other

Drug Formulation Services Offered
•	Analytical method development	•	Bioavailability enhancement
•	Compatibility studies of active ingredients		Dosage form selection
•	Excipient compatibility	•	Formulation optimization
•	Formulation stress testing		in silico studies
•	Manufacture of clinical supplies		Novel delivery system
•	Packaging compatibility assessment		Particle size reduction
•	Preclinical studies	•	Solubilizing water-insoluble drugs
•	Stability studies	•	Taste masking/flavorings

Other Services Offered
	Disease Research		Target Identification
	Lead Identification		Early Safety Tests
	Lead Optimization	•	Pre-clinical Studies
	IND Submission		Clinical Trials
	NDA Submission		Post-marketing Studies
•	Compendial Testing Of Raw Materials and Finished Products

Types of Drugs
•	Generics		•	Prescription		•	OTC

Dosage Forms
•	Capsules	•	Implantable
•	Inhalation	•	Injectible
•	Oral	•	Parenteral
	Peptide and Protein	•	Tablets
•	Topical

Company’s role in drug discovery and developmnet
ARL supports new drug development during the early stage of drug discovery and development through, chemical and physical characterization of drug substances and raw materials, pilot plant formulation development, compendia testing, QC release testing, drug release studies (dissolution, transdermal, etc.), In vitro/in vivo correlation (IVIVC) study, stability study for expiry dating, container/packaging compatibility, compatibility of IV admixtures, residual solvents determination, pharmacokinetic studies, data analysis, and report for CMC section in FDA submissions (IND, NDA, or ANDA).

Company’s experience and expertise in drug formulation
Our formulation experts are pharmaceutical scientists with a combined total of 70 years of experience with industrial pharmacy, physical pharmacy, pharmaceutics, and cGMP processes to reformulate generic drugs for clients (oral suspension, injectable solution, and topical cream formulations). We provide consultation to clients in their pre-formulation stage, conduct pilot formulation work, and collaborate with production group for scale-up manufacturing of these products. Some of these formulations are currently in the ANDA submission or review processes.

Relationship with pharma companies
As a CRO we provide formulation service and consultative function at all stages of drug development on contractual basis. We collaborate with pharma scientists to develop proposal protocols for intended work. Information is exchanged with client throughout the project life. Data reports and analysis are provided at the conclusion of the study, or at any time based on client request.

Factors critical for drug formulation
Successful formulation of a drug substance into a drug dosage form for therapeutic application must take into considerations the chemical, physical, and biological compatibility of the drug and the exciepients. All ingredients used in formulation must be compatible, stable, safe, and effective for the intended use.

a) Conduct pre-formulation work to gain basic information on the physical and chemical characteristics of the drug substance utilizing previous experience, available information, and through application of principles in physical, chemical, and biological sciences. Characteristics such as particle size, solubility, palatability, and stability are important in formulation development for proper choice of excipients, co-solvents, preservatives, and packaging.
b) Develop discriminatory in vitro drug release method to evaluate formulation variables.
c) Establish in vitro and in vivo correlation method of drug release study to set specifications for routine QC testing and stability testing of finished product.

Scientific/business/regulatory trends impacting drug formulation
Innovative therapy has lead to a new market for new drug delivery systems (e.g., drug eluting stents, nanoparticles, etc.). In addition, new biomarkers such as nucleic acids, peptides, and proteins are used therapeutically to treat various disorders and diseases. These biomarkers are potent drugs, but require stable formulation for controlled drug delivery or for targeted delivery to specific tissues. Formulations involving these biomarkers are complex and posed significant challenges in establishing IVIVC and setting specifications for quality control and stability testing.

The FDA implementation of quality by design principles or risk-based approach to cGMP impacts drug formulations. In quality by design environment, the critical attributes of a quality product determine product profile and quality control process. It allows more flexibility in manufacturing by providing opportunity for variation in material attributes without supplemental approval from the FDA.

Success story
ARL launched quality control testing for the compounding pharmacist beginning with three employees in 1994. The company has matured from bench level undergraduate analytical chemists to multiple PhD level scientists. ARL has a total of approximately 40 employees providing a multitude of analytical and knowledge based expertise to clients. The level of quality has grown exponentially by implementing ISO standards, including ISO 9001:2000 and moving into ISO 17025. ARL is registered with, and audited by, the FDA. ARL also maintains DEA registration. These registrations and independent audits from both regulatory bodies and clients provide for continuous quality improvement. The facilities have grown approximately 10 fold from where it began in its original facilities 10 years ago. Now occupying approximately 10,000 square feet of laboratory space, ARL is located in the central portion of the United States. ARL attracts international clients as well as customers from across the United States. The complexities of the services have advanced from providing quality control for compounders to include unique research projects for large pharma. This includes facilitating clients through the drug pipeline process on a variety of difficult formulations. ARL’s parent company acquired DNA Solutions, a genetics company, in 2000. This collaboration allows ARL to expand the concept of individualized medicine through pharmacogenomics and biomarkers. ARL’s success story illustrates the evolving role of a contract research organization.

How will roles of CROs and contract manufacturers change over the next few years?
The CROs and contract manufacturers are highly adaptable to regulatory trends and will be emerging markets for outsourcing formulation development, device development, clinical trials management, and scale-up manufacturing processes.