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36 October 2020 Tablets & Capsules under accelerated stability conditions of 40°C/75 percent relative humidity following Q1F stability guidelines of WHO [10]. The batches stored under ambient conditions were analyzed after five, six, and seven months, while the samples stored under accelerated conditions were analyzed after one, two, and three months. The tablet properties are shown in Table 2. The dissolution measurements are shown in Figure 2. The results show that it is pos- sible to obtain sufficiently hard enalapril maleate ODMTs at low compression force. The CU of the ODMTs showed an AV ≤ 15, which is within the specification require- ment. The formulation's mass varia- tion complied with the Ph.Eur. Over the stability test period, the ODMTs' disintegration time changed slightly under both stor- age conditions. However, both ini- tial and post-stability measurements showed that the enalapril maleate minitablets fulfilled both the Ph.Eur. disintegration limit of 180 seconds and the FDA disintegration limit of 30 seconds. This study demonstrates that low-dose enalapril-maleate orodis- persible minitablets can be success- fully produced by direct compres- sion using agglomerated isomalt as a filler- binder. T&C References 1. P. Nagar, K. Singh, I Chauhan, M. Verma, M. Yasir, et al. "Orally disintegrating tablets. Formulation, preparation, techniques and evalua- tion." Journal of Applied Pharmaceutical Science. Vol. 1 (2011), pages 33-45. 2. www.fda.gov/regulatory-infor- mation/search-fda-guidance-docu- ments/orally-disintegrating-tablets. Docket Number: FDA-2007-D-0365. 3. V. Klingmann, N. Spomer, C. Lerch, I. Stoltenberg, C. Frömke, H.M. Bosse, J. Breitkreutz, and T. Meissner, "Favorable acceptance of mini-tablets compared with syrup: A randomized controlled trial in infants and preschool children." The Journal of Pediatrics. Vol. 163 (2013), pages 1,728-1,732. 4. A. Lura, O. Luhn, J. Suarez Gonzales, and J. Breitkreutz. "New orodispersible mini-tablets for paedi- atric use – A comparison of isomalt with a mannitol based co-processed excipient." International Journal of Phar- maceutics. Vol. 572 (2019), 118804. 5. WHO Model Lists of Essential Medicines for Children: 20th List, 2019. www.who.int/selection_med icines/committees/expert/20/EMLc_ 2015_FINAL_amended_JUN2015. pdf?ua=1 (online 8/14/2019). 6. Peter Kleinebudde, "Pharmaze- utische Pellets durch Extrudieren/ Sphäronisieren: Herstellung, Eigen- schaften, Modifizierung." Habilita- tion thesis. 1997. 7. United States Pharmacopeia— National Formulary. USP. Rockville, MD, 2016. 8. European Pharmacopoeia (Ph. Eur.) 9 th edition. 9. J. B. Yasmin Thabet, "Orodis- persible films: Product transfer from lab-scale to continuous manufactur- ing," International journal of pharmaceutics. Vol. 535 (2018), pages 285-292. 10. WHO, "Q1F Stability Guide- line: Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical prod- ucts." www.ich.org/fileadmin/Public_ Web_Site/ICH_Products/Guidelines/ Quality/Q1F/Stability_Guideline_ WHO.pdf (online 8/14/2019). Michael Black is head of sales, pharma; Maj-Britt Cepok is head of business devel- opment, pharma; and, Oliver Luhn is head of pharmaceutical technology at Beneo (49 621 421 150, www.beneo. com). The results show that it is possible to obtain sufficiently hard enalapril maleate ODMTs at low compression force. SMART STARTS HERE: lgmpharma.com/tc Don't risk your investment with the wrong CDMO partner. Partner smart to secure and optimize your supply chain, from API sourcing through drug product development and manufacturing, to regulatory and market intelligence services. LGM Pharma empowers our clients with expert, customized services that accelerate safe, high-quality therapeutics to market. Read our white paper to learn how to outsmart your outsourcing. N O W T H AT ' S S M A RT. The right CDMO makes all the difference. Outsourcing, outsmarted. LGM_print ad_2.1875x10.indd 1 9/9/20 1:59 PM