Please explore the information provided below to learn more about the capabilities available through the Good Manufacturing Practice (GMP) facility at the University of Maryland School of Pharmacy.
Facilities and Capabilities:
The University of Maryland School of Pharmacy has a fully equipped Industrial Pharmaceutics Laboratory (IPL). The IPL has three 500 square-foot fully equipped laboratories, one 500 square-foot GLP laboratory, and six GMP pharmaceutical manufacturing suits. Also included are rooms for the receipt and storage of GMP materials. The laboratory is equipped to perform preformulation research, excipient screening, physical characterization of polymorphs, formulation and process development, GMP manufacturing, packaging and labeling of clinical supplies, and the laboratory equipment needed to evaluation these dosage forms using official USP methods such as the dissolution test. We can manufacture from the small-scale to the pilot-scale (i.e., from gram quantities to ca 50 kg scale). We also have validated stability cabinets to conduct stability studies in accordance with ICH guidelines. The IPL has experience supporting Phase I and early Phase II clinical trials.
Dosage Form Capabilities:
- The manufacturing suits are equipped with everything necessary to produce tablets, capsules, topical preparations, transdermal patches, nasal sprays, suppositories, liquid perpetrations, films strips, pellets, spray dried particles, and lyophilized drug products. We also have facilities for pan and fluid bed coating tablets, pellets, and granules. We do not produce sterile products for clinical studies.
- We can formulate and manufacture immediate and controlled release dosage forms.
- We have extensive experience manufacturing placebo liquids, capsules and tablets, transdermal patches under GMP conditions, and over encapsulate tablets, of reasonable size, and permanently seal the capsule shells for blinded studies.
- The capabilities of IPL include research on the quality and performance of botanicals and other dietary supplement formulations. Botanical products are among the most difficult types of formulations for which to develop placebos, because if the patient were to open a capsule and see a white powder they would immediately know it was a placebo. The color and taste have to be matched to the original product, which can be very challenging for botanical products that have a strong characteristic taste and appearance.
- We have extensive experience formulating and testing EPA and DHA fish oil capsules for clinical studies.
- We have formulated and tested oxytocin and scopolamine nasal spray devices for clinical studies.
- We have experience developing taste masking systems for pediatric formulations.
The services provided by the IPL include:
- Basic and applied research that focuses primarily on the design and optimization of immediate and extended release oral solid dosage forms for both their performance as drug delivery systems and their manufacturability
- Formulation and process development for the above dosage forms
- GMP manufacturing, packaging, and labeling, followed by release testing for the support of clinical trials
- Analytical method development, including physical tests, for analysis of dosage forms
- Stability testing in accordance with ICH guidelines
- IND/CMC document preparation for FDA filings
Current pricing is available on our website.
For More Information:
For more information about the capabilities of the GMP facility, please contact Stephen Hoag, PhD, professor in the Department of Pharmaceutical Sciences (PSC) and director of the GMP facility, at (410) 706-6865.