New Technology of Thermoplastic Coating for Osmotic Pump Tablets: Study on in vitro Drug Release

Abstract

Aim The in vitro drug release profiles of metformin hydrochloride thermoplastic coated tablets and nifedipine thermoplastic coated tablets were studied.

Methods By measuring the in vitro release profiles of the thermoplastic coated tablets of model drugs, the effects of membrane thickness, polyethylene glycol-1,500 (PEG1500) content, number of orifice, stirring speed, and release medium on the drug release were investigated, and the rule and mechanism of drug release were also analyzed by comparing with the osmotic pump tablets (OPTs).

Results Thermoplastic coated tablets with single- or double-chamber construction performed the same function of controlling the drug release, operated under the same release mechanism (osmotic pressure drove the drug release), and exhibited the same release characteristics (zero-order release, unaffected by release medium, and stirring speed) and release rule (release rate was inversely proportional to the membrane thickness but proportional to the PEG1500 content) as compared with OPTs prepared by the common spray coating technology.

Conclusion Thermoplastic coated tablets have the same release characteristics in vitro as OPTs. The new technology of thermoplastic coating can replace the spray coating technology of OPTs. This study provides theoretical basis and practical support for the industrialization and clinical application of thermoplastic coating technology.

Keywords

thermoplastic coating - spray coating - metformin hydrochloride - nifedipine - osmotic pump tablet

• References

• 1 Yuan CP, Hou HM, Qian MY. , et al. A new thermoplastic coating for osmotic pump tablets I. Development of preparation process. Carol J Pharm 2019; 50 (01) 48-58
• 2 Yuan CP, Hou HM, Ou SY. , et al. A new thermoplastic coating for osmotic pump tablets II. Evaluation of the coating membrane. Carol J Pharm 2019; 50 (02) 165-176
• 3 Swarbrick J, Boylan JC. Encyclopedia of Pharmaceutical Technology. Vol. I. 2nd ed. Wang H, Hou HM. , translate. Beijing: Science Press; 2009: 762
• 4 Guo ZR. Enduring and irreplaceable metformin. Yao Xue Xue Bao 2016; 51 (11) 1806-1808
• 5 Xu XN, Shi R, Ma YM. Research progress of pharmacokinetics of metformin based on transporters. Yao Xue Xue Bao 2017; 52 (06) 865-870
• 6 Yin F, Li W, Pan WL. Preparation and drug release in vitro of the metformin hydrochloride osmotic pump controlled release tablets. Pract Pharm Clin Remed 2009; 12 (03) 194-196
• 7 Ning MY, Zhou Y, Chen GJ. , et al. Preparation and in vitro evaluation of nifedipine osmotic pump system. Chin Hosp Pharm J 2010; 30 (23) 1963-1966
• 8 Chinese Pharmacopoeia Commission. The Pharmacopoeia of the People's Republic of China 2015 ed. Vol. II. Beijing: China Medical Science Press; 2015: 860-861
• 9 Yuan CP, Huang HK, Zhang WF. , et al. Evaluation on the in vitro release consistency between self-prepared nifedipine extended-release tablet (I) and original preparation. Yaowu Fenxi Zazhi 2013; 33 (08) 1416-1423
• 10 Niu JZ, Lin L, Zhang QM. The introduction of the judgement methods of dissolution profiles used in the USA and Japan. Chin J Drug Evaluation 2013; 30 (02) 67-69
• 11 Chinese Pharmacopoeia Commission. The Pharmacopoeia of the People's Republic of China 2015 ed. Vol. IV. Beijing: China Medical Science Press; 2015: 368
• 12 Zhang J, Fan GH, Liu H. , et al. Research progress of microporous osmotic pump controlled release preparation. Chin Hosp Pharm J 2013; 33 (16) 1351-1354
• 13 Malaterre V, Ogorka J, Loggia N, Gurny R. Approach to design push-pull osmotic pumps. Int J Pharm 2009; 376 (1,2): 56-62
• 14 Thombre AG, Cardinal JR, DeNoto AR, Gibbes DC. Asymmetric membrane capsules for osmotic drug delivery II. In vitro and in vivo drug release performance. J Control Release 1999; 57 (01) 65-73
• 15 Chen LL, Luo YN, Zhu CX. , et al. Research progress of controlled release drug delivery system for oral osmotic pump. Chin J Ethnomed Ethnopharm 2017; 26 (14) 61-65
• 16 Yan K, Mei XG. The mechanism, critical technology and progress of osmotic drug delivery systems. J Int Pharm Res 2010; 37 (02) 92-97