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    20 views4 pages

    Preventing Film Coating Problems Through Design

    Uploaded by

    Nataliya Slavova

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    stuart Porter, PhD, tec ad or Goda Fm Coating Technology st Ashland specatty Ingredents, wimington, 06 sporterdastiand com. TROUBLESHOOTING Preventing Film Coating Problems Through Design Defects in tablet film coating can be minimized by effective material and process design lim coatings on pharmaceutical tablets provide broad range of functionalities, and the coating formulation and process are complex, with many ‘tables. Figure 1 snows the variables associated with a pan-conting process, for example Al ofthese factors can potentialy influence ential quality attributes of the final coated product. Fim-coated products seem to exhibit more than their fairshare of defects although many fi-coating problems tend tobe visual or cosmetic defects that may ot negatively impact product efficacy, their exstence etracts om the perception of overall product qualty and may affect consumeripatient confidence, Many ‘common problems with fin-coated products and processes ae understood and solutions have been iscussed (1-8), Most ofthese problems can be avoided ia scienthicaly alié and proactive approach taken en designing formulations and processes, ‘Generally speaking, the key elements of any ft coated product are formulation and design a the core (to which te coating is applied, the coating formulation, and the coating process. n many cases, al three of these elements, in combination, play key ralein the presence or absence of coating detects, Problems associated with fim-coated products ‘may be classified as: + Visual detects + Issues associated with product functionality (eg, rug release behaviour) + Concerns with product stability + Factors affecting manufacturing costs. Identitying visual defects (and the extent to wich they occur can be eltvel simple, and there are proactive approaches to avoiding them, Product functionality and stability, However, presenta more complex situation, because the exstence of the problem is typical not apparent unt after the coating pracess has been concluded, and sample selection for testing Purposes often effectively precludes assessing the magnitude ofthe problem, Preventing problems is better than troubleshooting aterwards, Because regulatory issues (eg. after product nas been commercialized) may iit ‘troubleshooting solutions. indeed, he intent of quality by-design practices st inestigate all aspects ofthe product development process and identi etical {ualty atrbutes ana crtical process parameters. Ths article provides an overview of issues that should be considered when designing fim-coated products, Pan coating of tablets i used as an example, but many of the assertions ave relevant to fm coating in general, Core design Film-coating processes are stresful, both in terms ‘ofthe mactiancal ation tat takes place as well ‘as the environmental conditions (temperature and ‘humilty) within the coating process to which the praduct being coated will be exposed, These stress factors become more substantial when the coating process's scaled up from the laboratory to full-scale production, because the product exposure time to such concitions increases. ‘Thus, a sensible approach uses a core material ‘thats resistant to suen stressful conctons.n the case of tablets, designing cores that have exceptional mechanical properties (in terms of both ‘mechanical strength and fility characteristics) is essential, What isnot clear, however, is what defines ‘exceptional mechanical properties. The common practice i to define mechanical strength in terms of tablet. oreaking force, te required minimum value of which increases with increasing tablet size. For this reason, use of ow tality values becomes a good surrogate to help define tablet robustness. Regardless of tabiet size, tablets should possess friabity values of < 0.1% if they are to be successfully fm coated an the manufacturing scale. Examples of common defects that can be eliminated by effective core design are summarized ln Tabi Coating formulation design ‘The mechanical properties of the coating formulation are equay important to thse ofthe core, because Pharmaceutical Technology Europe rssusry 201 43 Troubleshooting both are subjected to the same stresses. To some extent, the ‘mechanical behaviour of the coating vl be augmented by that ofthe core, because the core essentially acts as 8 scaffold forthe coating Key attributes ofthe coating formulation tat, i suitably optimized, can contribute to the quality attroutes of the tral product ae discussed a follows. Mechanical strength (tensile strength ofthe coating. This atebute can effectively be used to Prevent edge chipping and cracking ofthe coating, which becomes much ‘more serious wen the applied coating has a funcional purpose, such as protecting the core trom feviranmental moisture or modifying srugrrelease characteristics (2, ‘delayed release and extended release products Coating flexibility (often defined Interms of elastic modulus), Coatings that ae flexible can offset ledge chipping and are iss likly to suffer from logo bridging problems. Foxible coatings can more easly changes tat are associated with various factors, such as post sweling due to thermal expansion ‘om exposure to process heat, and sweling due to moisture absorption 44 Pharmaceutical Technology Europe reamussy 201 In an aqueous coating process where drying condions are not ideal Coating adhesion characteristics. The surfaces of many pharmaceutical orl solids can present adhesion problems, especialy when the coating formusaton is detverea from an aqueous coating system. The reasons stem from lack of adequate core Porosity tothe formation of high energy surfaces where a high API content, coupled withthe known hydrophobic characteristics ofthe (eg, ibuprofen presenta surface thats dificult to wet wetting a necessary precursor to good ‘adhesion. although some ofthese Geficiencies can to some extent, be offset when employing suitable core formulation strategies, coating formulations wit hign adhesion characterstes, such as those based on polymer mixtures using hypromelise and copovidone or hose that uiiz polyvinyl alcoho as the primary polymer, can be useful in setting adhesion-elated problem such problems include coating rub-off asthe tablets tumble inthe coating pan and logo bridging where stresses that develop within the coatig on drying cause the coating to become detached within the fogo as a result of adhesive falluce (ee Table 0 Coating solution viscosity. The Use of high-soids coating systems ‘allows the amount of solvent water) that wll be sprayed to be reduced, while maintaining coating suspension well below the traktiona limit of 300 cP required to produce a quality Coating. These systems offers many benefits, inctuing + Reducing coating process time, thus minimizing process costs, ‘as well as exposure time of tablets to stressful process conditions improving product stability, felher as a reut of reduced process exposure time to high processing temperatures and humidities, or by minimizing moisture penetration into the cores, especially wnen process High sods coatings contain less water, thus presenting less of @ thermodynamic challenge tothe ‘evaporative capabiltes ofthe coating process Facltating the use of lower processing temperatures, which can be beneficial thermolable 2's. Ie shouldbe recognized that rodsy many pharmaceutical companies prefer to buy ready-made coating systems fram one ofa numberof suppliers. In those cases, close collaboration withthe selected suppliers is necessary to ensure that the coating system chosen Is optimal for the product being coated and the coating process that willbe used. Although core and coating formulation need tobe well understood to avo downstream problems, the coating process also plays a major role. Three important ‘areas of any coating process that need close attention areas follow Coating process thermodynamics. Process thermodynamics affect the ability of the process ar stream to effectively remove solvent (eg, waten. The main variables are temperature, moisture content, an air mass (or volume) Spray dynamic. spray dynamics Influences croplet ze and size Astrouton, veto, and drying while Troubleshooting ‘able tA summary of coating Issues that can be avoided through effective core design. Defect Description Tablet twinning | Tablets stick together, oaches to minimize defect: ‘Avoid use of tablets with large areas of fiat surfaces. For capsule-shaped tablets, instead of creating tablets itn straight sides as shown in the photograph) introduce a sight degree of curvature to minimize the risk of tablets sticking together when they are in the tacky phase ust after coating has been depasited on ‘the surface Tablet core erosion Jor tate | Erosion occurs on faces | | | Ensure that tablets meet minimum frabilty standards (0.1%, Expose tablet cores to large-scale coating process Conditions before core formulation i finalized, Tablet breakage | hie tumbling in the pan, | raves brat aurng pen | |ieangr urea or | Ensure tablets meet minimum breaking force standards (for tablets > 500 mg, 180-200N; for tablets 150-500 mg, 130-160N; for tablets < 150mg, 80-100N are useful targets Examine pan loading and unloading procedures to minimize damage. | Tablets chip on sharp edge chipping | corners dand area). Select compound radius punches to minimize sharpness of edges on tablets. ‘Add plastically deforming excipients e., microcrystalline cellulose (MCC, hydroxypropyl Cellulose) to core formulations to minimize brittleness. Ensure tablet fiabilty values are < 0.1%. Coating bridges across Logo bridging) in fight from the nozzle to the surface of the tablet bed tao influences spray fx, which sa combination of spray rate nd the area over which coating laud is detivered from each spray gun onto the surface ofthe tablet bed. Sora fx from each spray gun in a muit-gun set up may not be dentcal, unless the spray rate and atomization conditions are identical for each spray nozzle. Spray ‘dynamics als influence uniformity of the clstribution ofthe coating. Spray ‘tynaics canbe infuenced by: + spray rate + Solids content ofthe coating igus + Viscosity ofthe coating tquia + atomizing air press and volume ce au for the + Patter alr pressure and volume + Gunto-bed distance + Process airflow inside the coating pan, ‘Those process factors, even when retully selected during process sat up, rarely stay constant throughout 1 coating process. although r-to-bed distance may have been measured during gun setup, example ican change a the bet bed moves because tablets flow across the surtaces of baftes, using the tablet surface to move back and forth as the pan rotates. In addition, a tne coating is apalies, sip ofthe tablets can change, 1 the angle of the surface ofthe tablet bed may change with it Ensure that tablet core formulations ae sufficiently robust to avoid need for high compaction forces, hich can negatively affect core porosity a positive factor in adhesion requirements Include hydrophilic excipient (eg, MCC) in core formulation that can enhance adhesion of fim coating Tablet movement within ‘the coating pan. This aspect of ‘the coating process wil affect attrtional effects within the process (and hence mechanical ‘damage to tne tablets) and coating distribution uniformity across a batch of tablets. Tablet movement may Impact drying within the tablet bed, because the faster the tablets move, the shorter the time inthe spray zone, the less coating material each tablet picks up, and the faster that amaunt of coating material can cry. Generally, as long as the tabet cores and coating formulation are suitably robust, the faster the tablet motion within the coating pan the better. Pharmaceutical Technology Europe rowusy 2o%e 45 ‘Troubleshooting So ent eee Pietra a) Defect ription Eo oe 1. Reduce processing temperatures to minimize Coating cracks due to thermal | core thermal expansion Fim cracking | expansion of tablet cores and 2, Reduce drying conditions (or increase spray (ype 0 lack of fm flexibility caused rate) so that some moisture retention in the by overdrying, coating occurs to augment plastcization effects (thus increasing fim flexibility) een 1. move drying edu soay ret or nerease a beetle y ) Temperature tof oveettng Fim cracking | Swalri.caused by exces 2. itoese pansoeed to minimize Gel time in type | moan aero Some cores during appcation Pm 2 Gee ha sce costing systems toreauce " ‘moisture burden on the drying process. 1. Minimize foam generation during preparation of coating suspension, 2. Reduce atomizing conditions and/or reduce

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