Acquiring pharmaceutical processing equipment and successfully integrating it into operations is not as straightforward as it may seem. Whether used or new, everything is up for consideration and evaluation: vendor, type, specifications, performance, reliability, capability, service life, price, and importantly, availability. Oral solid dose (OSD) manufacturing, especially at commercial scale, is particularly dependent on the operational efficiency of a familiar but increasingly complex train of processing equipment to mass produce tablets and capsules. More than ever, the success of a particular OSD product rests on operational excellence and the ability to deliver high-performing, variation-free process.
Almac has developed a flexible paediatric dosage form consisting of minitablets filled into stickpacks using a robust manufacturing and filling process suitable for routine commercial manufacture.
Compression tooling and tablet press manufacturers are faced with ongoing challenges in the tablet manufacturing environments. Providing support in all aspects of the tablet compression process should be expected from your tooling and tablet press partner. These services should include: press operator training, maintenance/calibration services, quick delivery of replacement parts, tooling, tablet design and powder formulation support.
To demonstrate the process by which a placebo formulation was designed for an oral solid dose product that would be dispensed to the patient as a fast-dissolve tablet. The tablet is added to water and the resulting solution is dosed as a antibiotic mouthwash. Placebo matching was required not only for the tablet but also for the solution which the patient took.
Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties of drug products. The in-vitro disintegration and dissolution times of tablets and capsules can vary significantly based on their composition and processing.
In this installation, materials are received in 50-pound bags and semi-bulk bags and are security screened for foreign objects while being conveyed to a weigh hopper, where they are automatically hatched in predetermined weights and discharged into process drums.
Medical prescription drug errors by doctors, pharmacists and patients account for 1.5 million incidences of sickness, injuries or deaths in the U.S. each year. By Jay Anbil and Steve Yoder