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Why Oral Disintegrating Tablets? Roquette WHY ORAL DISINTEGRATING TABLETS? In this piece, Carmen Popescu, PhD, Senior Project Coordinator, Roquette, provides an overview of the Orally Disintegrating Tablet (ODT) landscape, describing how these dosage forms can be used to improve and differentiate drug products, different manufacturing methods and how this class of oral delivery system might be applied in the future. Oral Disintigrating Tablets (ODTs) the increased popularity of ODTs on the are patient-centric drug delivery systems market, the excipients industry created (for example, for paediatrics, geriatrics, ready-to-use platforms in order to ease the and psychiatric patients with dysphagia) formulation process. designed to increase patient compliance. ODTs are preferred to classic dosage forms WHAT ARE THE MAIN (swallowable / chewable / suckable tablets) REQUIREMENTS FOR AN ODT? due to ease of administration (portability, “on the go”) without water, pleasant taste As per the US and EU pharmacopoeias, and mouth-feel – more of “a treat” than a an ODT has to weigh 500 mg (EP, USP) or less, disintegrate in 2 mL available saliva in less than 30 seconds (USP) or 180 “Recently, the US FDA seconds (EP) and the friability is to be approved SPRITAM ≤1% (EU, USP).1,2,3 In order to satisfy these requirements, the (levetiracetem) ODT filler has to create a porous matrix in which tablets produced by 3D the 2 mL saliva will be fast-channelled to the printing. This is a super disintegrant in order to break down within 30 seconds (Figure 1). Mannitol significant step towards is the chosen filler (but there are other personalised drug delivery.” candidates like dextrose, lactose, starch, etc) due to it being water soluble but not hygroscopic (reduce interaction with the treatment. Reduced first-pass metabolism, water penetration through the matrix pores) faster onset of action, better absorption and, and protects actives stability. Dr Carmen Popescu in turn, improved bioavailability are their Senior Project Coordinator very appealing benefits. Manufacturers’ WHAT PROCESSES ARE AVAILABLE T: +1 630 463 9436 E: [email protected] attraction for these dosage forms resides TO MANUFACTURE ODTS? in improved lifecycle management, market differentiation, innovation and brand Freeze-drying, spray-drying, direct Roquette America, Inc creation. Moreover, in recent years, we compression, molding sublimation, mass 2211 Innovation Drive Geneva, IL 60134 can see their remarkable expansion from extrusion, and cotton candy are the United States Rx to OTC, nutraceuticals (vitamins, commonly used methods in the industry. minerals, etc) and biologics. In response to Amongst these, direct compression is the www.roquette.com Copyright © 2016 Frederick Furness Publishing Ltd www.ondrugdelivery.com 35 Roquette most cost-effective and easy-to-handle Direct compression on standard equipment, resulting in low- excipient (not hygroscopic) friability tablets. Direct compression In recent years, the excipients industry 2 excipient (hydrophilic) has developed a number of ready-to-use 1 ODT platforms by co-processing the filler, Disintegrant (hydrophilic) usually mannitol, with a superdisintegrant. 3 The platforms include: 1 : to ease the liquid penetration 2 : to target the super disintegrant ® Lubricant (hydrophobic) • F-MELT (Fuji Chemical Industries, 3 : to not hamper the liquid penetration Case study N°1 Tokyo, Japan) • Ludiflash® (BASF, Ludwigshafen, Germany) Figure 1: Mechanisms of ODT disintegration. • Parteck® ODT (Merck Millipore, Figure 1: ODT disintegration mechanism. Billerica, MA, US) ® USP Pharmacopeia method (no correla3on) Texture analyser method (good correlation) • Pearlitol Flash (Roquette Pharma,1 Lestrem, France) 140 ® • Pharmaburst (SPI Pharma, Wilmington, 250 120 y = 0,4353x + 15,046 DE, US) R² = 0.9223 100 200 • PROSOLV® ODT (JRS Pharma, 80 150 Rosenberg, Germany) 60 100 disintegration time (s) 40 disintegration time time (s) disintegration 50 The main challenge in ODT formulation 20 In vivo In vivo is the excipients screening in order to find 0 0 0 100 200 300 400 500 0 100 200 300 400 500 the right balance between disintegration In vitro disintegration time (s) Time of collapse (s) time, friability, API stability and mouth feel. These aspects are explored in greater detail Figure 2 Disintegration time in vitro/in vivo correlation. in the case studies that follow. Figure 2 Disintegra.on .me in vitro/in vivo correla.on CASE STUDY 1 Tablet hardness has no effect on the recorded. Mouth-feel is critical in patient disintegration time in vitro (both methods acceptance of an ODT (due to its residence Disintegration-Time Optimisation Figure 3a and Figure 3b) or in vivo time in the buccal area) and is very much of Ready-to-Use Platforms (Figure 3c) for P1 while for the other linked to attributes such as smooth, Disintegration time can be evaluated in platforms there is noticeable variation as creamy, sweet, etc. Unfortunately, vitro as per the USP/EU Pharmacopoeias’ a function of hardness. The reason for for some ODT platforms, the synthetic methods or any method using Texture P1’s short disintegration time resides in origin of their components seems to affect Analyzer and their correlation with in vivo the water access (through porous matrix) their taste and texture negatively. evaluation by a taste panel (Figure 2). to the disintegrant due to its superior The taste panel evaluation of P1 to P4 300 mg ODT placebos were made wettability compared with the other commercially available ODT platforms using ready-to-use ODT platforms at two platforms (Figure 4). were as follows: hardness values (50 N and 90 N) and their disintegration times were evaluated in vitro CASE STUDY 2 P1: Sweet taste, creamy, smooth and fine (Figure 3a & b) and in vivo (Figure 3c). texture and off notes (Medicinal) ODT platforms composition filler: Impact of ODT Platform P2: Creamy and sticky texture and off notes disintegrant is as follows: P1 (Mannitol: Composition on Mouth-Feel (Dry, Glue, Cardboard, Bitter) Starch); P2 (Mannitol: Crospovidone, PVA, 24-trained panelists were asked to put P3: Not very sweet, takes too long time to PVP, SLS); P3 (Mannitol: Crospovidone, an ODT placebo between tongue and melt and off notes (Cardboard, Bitter) MCC, SiO2, Fructose) and P4 (Mannitol: palate applyingC a sslighte N °pressure1 and then P4: Takes too long to melt, hard center and Croscarmellose). their opinion about the mouthfeel was off notes (Cardboard,Case N° 1Chemical) Case study N°1 149149 149 259 248 242 50N 90N 50N 90N 199 186 89 50N 90 N 80 136 65 119 (s) 82 32 58 43 54 39 20 disintegration 40 20 27 time (s) 36 USP disintegration time (s) USP In vivo P1 P2 P3 P5 analyzer disintegration time Texture P1 P2 P3 P5 P1 P2 P3 P5 ODT Platform ODT Platform ODT Platform Figure 3: Disintegration times (a) in vitro, using the USP method, (b) in vitro using Texture analyzer method, and (c) in vivo. Figure 3 :(a) in vitro disintegration time ( USP) Figure 3:(b) in vitro disintegration time Texture analyzer Figure 3: (c) in vivo disintegration time 36 www.ondrugdelivery.com Copyright © 2016 Frederick Furness Publishing Ltd Case study N°1 Roquette CASE STUDY 3 1 Impact of ODT Platform Composition 0.9 ODT Crospovidone on Chemical & Physical Stability ODTs were formulated with 6% benzo- 0.8 ODT Starch caine (as a model drug), 1.5% magnesium stearate, and 92.5% of the respective P1, 0.7 P2, P3 ODT platforms (as described previ- 0.6 ously) and P4 (mannitol: xylitol , MCC, crospovidone, Mg alumino silicate, DCP). 0.5 Each formulation was tableted at 500 mg ODT Croscarmellose weight using 10 mm diameter concave 0.4 punches on a Korsch XP1 research tableting Penetration Index machine under two conditions. 0.3 The tablets in the first set were produced at different compression force depending 0.2 on platform compressibility to create tablets with an average hardness of 100 N. 0.1 The tablets in the second set were made under a constant compression force of 0 20 kN, which resulted in tablets with 0 0.5 1 1.5 2 2.5 3 3.5 varying hardness. Tablets were evaluated Figure 4: Wettability of ODT platforms with Timediffering (s) disintegrants (P1 has the fastest in accordance with US Pharmacopoeia disintegration due to highest disintegrant wettability). methods for hardness, friability, and in vitro disintegration time. Tablets were Figure 4: Wetability of ODT platforms disintegrants (P1 has the fastest disintegration due to placed under ICH stability conditions in highestpropensity disintegrant (H2N group) wetability) to degrade under reducing sugar (fructose), superdisintegrants humidity chambers at 25°C/60% RH or certain circumstances (reducing sugars, and MCC (see Figure 5), while chemical under accelerated conditions, 40°C/75% formic acid, and formaldehyde) and its stability was impaired by reducing RH, for up to six months in open pans. degradation (Brown Millard reaction, sugar (fructose) and reactive residues Following storage under the various stability N- Formyl benzocaine, p-amino benzoic (peroxides, formic acid and formaldehyde) conditions, tablets were photographed acid, amide degradation product) under in crospovidone, PVP or PVA. P1 and and their diameter measured. Benzocaine stability conditions was evaluated by LCMS. P2 displayed a very good chemical and was chosen as a model drug due to its Physical stability was impacted by physical stability.Ca4 se study N°3 Benzocaine ODT formulations Mannitol Maize starch Mannitol Crospovidone PVP PVA SLS Mannitol Crospovidone MCC SiO2 Fructose Mannitol Xylitol MCC/Crospovidone Mg alumino silicate DCP Figure 5: Benzocaine stability study results. Figure 5: Benzocaine stability study results. Copyright © 2016 Frederick Furness Publishing Ltd www.ondrugdelivery.com 37 Roquette ODT BY 3D PRINTING: and solubility reduction. However, in the A TRANSITION TO case of ODTs, due to low compression force ABOUT THE PERSONALISED MEDICINE applied, the particle size is not changed. For the same reasons, ODTs are AUTHOR Recently, the US FDA approved SPRITAM potentially very suitable for protein and Dr Carmen Popescu holds a BS in (levetiracetem) ODT tablets produced peptide delivery, preserving their structure, Physics and a PhD in Biophysics from by 3D printing.
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