Research Scholar, Dept. of Pharmaceutical technology,
AU College of Pharmaceutical Sciences, ANDHRA UNIVERSITY. A P, India
*e-mail: [email protected]
Tablets, a dosage form that stood the test of time have evolved from being a simple uncoated tablet for oral administration giving immediate release, to sustained release systems that can be implanted into the body. Industrial production of tablets has progressed to complete automation. With trend towards global marketing and regulatory requirements, the specifications for the facility, the processes and the product too are becoming more stringent in recent times. Tableting technology has advanced to meet the requirements of the growing market.
Keywords: Recent, Technology, Tablet, Quality
The recent trends in tablet formulation are
1.Versatile immediate release tablet systems including fast dissolving drug delivery systems, orally disintegrating tablets/ orally dispersible tablets, orally dispersible mini tablets, mouth dissolving/ fast dissolving tablets, novel fixed dose combination tablet ACCU-BREAK technology inactive layer between two different drug layers), conventional effervescent, uncoated and film–coated tablets etc.
2. Modified release tablet formulations including ring cap coated tablet ALZA, layered tablets (in lay, tablet in tablet, bilayered tablet), novel chewable sustained release tablet and direct compression medicated chewing gum.
3. Excipient technology is advancing to produce directly compressible materials for both immediate release as in mouth dissolving systems, or for sustained release systems. The research in excipients is meeting pace with the high throughput production of tablets. Research is also advancing into obtaining excipients from natural sources.Various commercial excipients such as Lycoat, Readily coat, Instamodel and Instanute DR are available in the market.
The recent trends in production equipment advancement are
In Pre-compression equipment – TOPO granulation technology for effervescent tablets employs vacuum for easy processing of the moisture susceptible material has been introduced. Integration of design by combining fluid bed dryers and coaters with top-drive and bottom-drive high shear mixer/granulators, wet and dry milling facilities, product handling systems, binder and coating preparation units.
a) Double punch technology using OSDrC® technology/one-step dry-coating technology. This rotary tableting machine has 54 double punches and three feeders. One-step manufacture of divided tablets with two cores, pulsatile tablets with three cores, combination products, tablet in tablet, new oral rapid disintegration tablets.
b) Exchangeable compression module (ECM) where all parts are in contact with the product, including the tooling, is encapsulated inside the closed ECM. The ECM is easily removed from the machine in a fast and contained manner, completely eliminating the need for cleaning of the inside of the press.
c) Exchangeable Die-Disc Technology: The PERFORMA with Exchangeable Turret and Exchangeable Die Disc. PERFORMA P will be available with a bi-layer kit, which quickly transforms the standard machine making it capable of both single- and bi-layer production. The bi-layer kit consists of only a few components, which are very quick and easy to install.
d) MODUL (WOL): Wash-off-line Exchangeable Compression Module (WOL-ECM): Against the WIP (wash in place) CIP (clean in place) concept, the latest is WOL (wash -off line). After the WOL-ECM has been removed from the machine, it can be connected to a washing station in the cleaning area. “Off-line” automatic washing offers considerable advantages over “in-place” washing.
5. In-process testing instruments ( PAT) including Viswill Tablet Video Inspection system TVIS-EX3-CD (all surfaces inspected in a single pass), Dr Schleuniger Pharmatron (advanced PAT system for automatic content uniformity testing with NIR for real-time release), PEPI (phi eco planar imaging) for distribution of material during blending, NIR to track blend homogeneity, surveillance with camera and image recognition software for spray drying, with PLC, lyophilization – online drying rate monitoring, monitor blending, LOD, granule size, granule growth and NIR spectroscopy for moisture content.
6.Miscellaneous: Advances in packaging technology, finished product testing like dissolution apparatus, disintegration testers, coating technology, equipment or methods for containment, tablet de dusters, clean in place systems, material handling systems, product storage and distribution systems are all geared up to avoid cross contamination, build in quality and meet the high rates of production. Nondestructive tablet hardness testing by near-infrared spectroscopy: a new and robust spectral best-fit algorithm.
7. Automation and integration with controller area network (CAN) programmable logic controllers, CAD/CAM, linux/unix, C c++, process analytical technology, real time release (rtr). It is the computer technology advances with the use of programs and algorithms that made automation possible. Validation of computer systems is one major aspect of production. Consigma is an example of all in one from powder to tablet technology.
Advances in tableting technology are a vast area for discussion. Tablet formula, the excipients used, the production process starting from receipt of raw material through the intermediate processing steps to the finished product at high speeds; the entire documentation too is seeing automation. Reproducibility, accuracy and consistency are being achieved due to the development in tableting science. Contribution to quality by design is being made possible ultimately contributing to quality, safety and efficacy of the drug product.