Optimizing formulation parameters for the development of carvedilol injectable in situ forming depots

References

• Abdelbary AA, Al-Mahallawi AM, Abdelrahim ME, Ali AMA. 2015. Preparation, optimization, and in vitro simulated inhalation delivery of carvedilol nanoparticles loaded on a coarse carrier intended for pulmonary administration. Int J Nanomedicine. 10:6339–6353. doi:10.2147/IJN.S91631.
   PubMed Web of Science ®Google Scholar
• Abulateefeh SR. 2023. Long-acting injectable PLGA/PLA depots for leuprolide acetate: successful translation from bench to clinic. Drug Deliv Transl Res. 13(2):520–530. doi:10.1007/s13346-022-01228-0.
   PubMed Web of Science ®Google Scholar
• Ahmed TA, Ibrahim HM, Samy AM, Kaseem A, Nutan MTH, Hussain MD. 2014. Biodegradable Injectable in situ implants and microparticles for sustained release of Montelukast: in vitro release, pharmacokinetics, and stability. AAPS PharmSciTech. 15(3):772–780. doi:10.1208/s12249-014-0101-3.
   PubMed Web of Science ®Google Scholar
• Al-Tahami K, Meyer A, Singh J. 2006. Poly lactic acid based injectable delivery systems for controlled release of a model protein, lysozyme. Pharm Dev Technol. 11(1):79–86. doi:10.1080/10837450500464040.
   PubMed Web of Science ®Google Scholar
• Amini-Fazl MS. 2022. Biodegradation study of PLGA as an injectable in situ depot-forming implant for controlled release of paclitaxel. Polym Bull. 79(5):2763–2776. doi:10.1007/s00289-020-03347-5.
   Web of Science ®Google Scholar
• Assali M, Zaid AN, Bani-Odeh M, Faroun M, Muzaffar R, Sawalha H. 2017. Preparation and characterization of carvedilol-loaded poly(D, L) lactide nanoparticles/microparticles as a sustained-release system. Int J Polym Mater Polym Biomater. 66(14):717–725. doi:10.1080/00914037.2016.1263951.
   Web of Science ®Google Scholar
• Aulton ME. 2001. Pharmaceutics : the science of dosage form design. Edinburgh: Churchill Livingstone.
   Google Scholar
• Avachat AM, Kapure SS. 2014. Asenapine maleate in situ forming biodegradable implant: an approach to enhance bioavailability. Int J Pharm. 477(1-2):64–72. doi:10.1016/j.ijpharm.2014.10.006.
   PubMedGoogle Scholar
• Brodbeck KJ, DesNoyer JR, McHugh AJ. 1999. Phase inversion dynamics of PLGA solutions related to drug delivery. J Control Release. 62(3):333–344. doi:10.1016/S0168-3659(99)00159-5.
   PubMed Web of Science ®Google Scholar
• Camargo JA, Sapin A, Nouvel C, Daloz D, Leonard M, Bonneaux F, Six J-L, Maincent P. 2013. Injectable PLA-based in situ forming implants for controlled release of Ivermectin a BCS Class II drug: solvent selection based on physico-chemical characterization. Drug Dev Ind Pharm. 39(1):146–155. doi:10.3109/03639045.2012.660952.
   PubMed Web of Science ®Google Scholar
• Castro KCd, Costa JM, Campos MGN. 2022. Drug-loaded polymeric nanoparticles: a review. Int J Polym Mater Polym Biomater. 71(1):1–13. doi:10.1080/00914037.2020.1798436.
   Web of Science ®Google Scholar
• Chen W, Lamey K, Oh C, inventors; Lamey Kimberly A, assignee. 2006 May 4. Carvedilol pharmasolve solvate. United States patent application US 10/513,234.
   Google Scholar
• Chhabra S, Sachdeva V, Singh S. 2007. Influence of end groups on in vitro release and biological activity of lysozyme from a phase-sensitive smart polymer-based in situ gel forming controlled release drug delivery system. Int J Pharm. 342(1–2):72–77. doi:10.1016/j.ijpharm.2007.04.034.
   PubMedGoogle Scholar
• Dhawan S, Kapil R, Kapoor DN. 2011. Development and evaluation of in situ gel-forming system for sustained delivery of insulin. J Biomater Appl. 25(7):699–720. doi:10.1177/0885328209359959.
   PubMed Web of Science ®Google Scholar
• Dunn RL, English JP, Cowsar DR, Vanderbilt DP, inventors; Atrix Laboratories Inc, assignee. 1990 Jul 3. Biodegradable in-situ forming implants and methods of producing the same. United States patent US 4,938,763.
   Google Scholar
• FDA. 2003. Food and Drug Administration, Coreg® Approved Labeling [Internet]. [accessed 2022 Nov 7]. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-297S009_Coreg_prntlbl.pdf.
   Google Scholar
• Felton LA. 2013. Mechanisms of polymeric film formation. Int J Pharm. 457(2):423–427. doi:10.1016/j.ijpharm.2012.12.027.
   PubMed Web of Science ®Google Scholar
• Hamed R, Awadallah A, Sunoqrot S, Tarawneh O, Nazzal S, AlBaraghthi T, Al Sayyad J, Abbas A. 2016. pH-dependent solubility and dissolution behavior of carvedilol—case example of a weakly basic BCS class II Drug. AAPS PharmSciTech. 17(2):418–426. doi:10.1208/s12249-015-0365-2.
   PubMed Web of Science ®Google Scholar
• Hansen CM. 2007. Hansen Solubility Parameters. Boca Raton: CRC Press. doi:10.1201/9781420006834.
   Google Scholar
• Ibrahim TM, El-Megrab NA, El-Nahas HM. 2021. An overview of PLGA in-situ forming implants based on solvent exchange technique: effect of formulation components and characterization. Pharm Dev Technol. 26(7):709–728. doi:10.1080/10837450.2021.1944207.
   PubMed Web of Science ®Google Scholar
• Jantzen GM, Robinson JR. 2002. Sustained-and controlled-release drug delivery systems. In: Banker GS, Siepmann J, Rhodes C, editors. Modern Pharmaceutics. Vol. 121. 4th ed. New York: MARCEL DEKKER AG; p. 501–528. doi:10.1201/9780824744694.
   Google Scholar
• Jouyban A, Fakhree MAA, Shayanfar A. 2010. Review of pharmaceutical applications of N-Methyl-2-Pyrrolidone. J Pharm Pharm Sci. 13(4):524–535. doi:10.18433/J3P306.
   PubMed Web of Science ®Google Scholar
• Kamaly N, Yameen B, Wu J, Farokhzad OC. 2016. Degradable controlled-release polymers and polymeric nanoparticles: mechanisms of controlling drug release. Chem Rev. 116(4):2602–2663. doi:10.1021/acs.chemrev.5b00346.
   PubMed Web of Science ®Google Scholar
• Kapoor DN, Katare OP, Dhawan S. 2012. In situ forming implant for controlled delivery of an anti-HIV fusion inhibitor. Int J Pharm. 426(1–2):132–143. doi:10.1016/j.ijpharm.2012.01.005.
   PubMedGoogle Scholar
• Lambert WJ, Peck KD. 1995. Development of an in situ forming biodegradable poly-lactide-coglycolide system for the controlled release of proteins. J Controlled Release. 33(1):189–195. doi:10.1016/0168-3659(94)00083-7.
   Web of Science ®Google Scholar
• Li Z, Mu H, Weng Larsen S, Jensen H, Østergaard J. 2021. An in vitro gel-based system for characterizing and predicting the long-term performance of PLGA in situ forming implants. Int J Pharm. 609:121183. doi:10.1016/j.ijpharm.2021.121183.
   PubMedGoogle Scholar
• Lin X, Shi X, Zheng X, Shen L, Feng Y. 2014. Injectable long-acting systems for Radix Ophiopogonis polysaccharide based on mono-PEGylation and in situ formation of a PLGA depot. Int J Nanomedicine. 9:5555–5563. doi:10.2147/IJN.S71819.
   PubMed Web of Science ®Google Scholar
• Lipp L, Sharma D, Banerjee A, Singh J. 2020. In vitro and in vivo optimization of phase sensitive smart polymer for controlled delivery of rivastigmine for treatment of alzheimer’s disease. Pharm Res. 37(3):34. doi:10.1007/s11095-020-2757-6.
   PubMed Web of Science ®Google Scholar
• Liu D, Xu H, Tian B, Yuan K, Pan H, Ma S, Yang X, Pan W. 2012. Fabrication of carvedilol nanosuspensions through the anti-solvent precipitation–ultrasonication method for the improvement of dissolution rate and oral bioavailability. AAPS PharmSciTech. 13(1):295–304. doi:10.1208/s12249-011-9750-7.
   PubMed Web of Science ®Google Scholar
• Liu H, Venkatraman SS. 2012a. Effect of polymer type on the dynamics of phase inversion and drug release in injectable in situ gelling systems. J Biomater Sci Polym Ed. 23(1–4):251–266. doi:10.1163/092050610X549171.
   PubMed Web of Science ®Google Scholar
• Liu H, Venkatraman SS. 2012b. Cosolvent effects on the drug release and depot swelling in injectable in situ depot-forming systems. J Pharm Sci. 101(5):1783–1793. doi:10.1002/jps.23065.
   PubMed Web of Science ®Google Scholar
• Liu P, Chen G, Zhang J. 2022. A review of liposomes as a drug delivery system: current status of approved products, regulatory environments, and future perspectives. Molecules. 27(4):1372. doi:10.3390/molecules27041372.
   PubMed Web of Science ®Google Scholar
• Liu Q, Zhang H, Zhou G, Xie S, Zou H, Yu Y, Li G, Sun D, Zhang G, Lu Y, et al. 2010. In vitro and in vivo study of thymosin alpha1 biodegradable in situ forming poly(lactide-co-glycolide) implants. Int J Pharm. 397(1–2):122–129. doi:10.1016/j.ijpharm.2010.07.015.
   PubMed Web of Science ®Google Scholar
• Mao S, Guo C, Shi Y, Li LC. 2012. Recent advances in polymeric microspheres for parenteral drug delivery – part 1. Expert Opin Drug Deliv. 9(9):1161–1176. doi:10.1517/17425247.2012.709844.
   PubMed Web of Science ®Google Scholar
• McHugh AJ. 2005. The role of polymer membrane formation in sustained release drug delivery systems. J Control Release. 109(1–3):211–221. doi:10.1016/j.jconrel.2005.09.038.
   PubMed Web of Science ®Google Scholar
• Nikolov A, Wasan D. 2017. Oil lenses on the air–water surface and the validity of Neumann’s rule. Adv Colloid Interface Sci. 244:174–183. doi:10.1016/j.cis.2016.05.003.
   PubMed Web of Science ®Google Scholar
• Packhaeuser CB, Schnieders J, Oster CG, Kissel T. 2004. In situ forming parenteral drug delivery systems: an overview. Eur J Pharm Biopharm. 58(2):445–455. doi:10.1016/j.ejpb.2004.03.003.
   PubMed Web of Science ®Google Scholar
• Pandya AK, Vora LK, Umeyor C, Surve D, Patel A, Biswas S, Patel K, Patravale VB. 2023. Polymeric in situ forming depots for long-acting drug delivery systems. Adv Drug Deliv Rev. 200:115003. doi:10.1016/j.addr.2023.115003.
   PubMed Web of Science ®Google Scholar
• Parent M, Nouvel C, Koerber M, Sapin A, Maincent P, Boudier A. 2013. PLGA in situ implants formed by phase inversion: Critical physicochemical parameters to modulate drug release. J Control Release. 172(1):292–304. doi:10.1016/j.jconrel.2013.08.024.
   PubMed Web of Science ®Google Scholar
• Perumal S, Atchudan R, Lee W. 2022. A review of polymeric micelles and their applications. Polymers. 14(12):2510. doi:10.3390/polym14122510.
   PubMed Web of Science ®Google Scholar
• Saindane NS, Pagar KP, Vavia PR. 2013. Nanosuspension based in situ gelling nasal spray of carvedilol: development, in vitro and in vivo characterization. AAPS PharmSciTech. 14(1):189–199. doi:10.1208/s12249-012-9896-y.
   PubMed Web of Science ®Google Scholar
• Sanders LM, Kell BA, McRae GI, Whitehead GW. 1986. Prolonged controlled-release of nafarelin, a luteinizing hormone-releasing hormone analogue, from biodegradable polymeric implants: influence of composition and molecular weight of polymer. J Pharm Sci. 75(4):356–360. doi:10.1002/jps.2600750407.
   PubMed Web of Science ®Google Scholar
• Santos A, Sinn Aw M, Bariana M, Kumeria T, Wang Y, Losic D. 2014. Drug-releasing implants: current progress, challenges and perspectives. J Mater Chem B. 2(37):6157–6182. doi:10.1039/C4TB00548A.
   PubMed Web of Science ®Google Scholar
• Sharma A. 1997. Liposomes in drug delivery: progress and limitations. Int J Pharm. 154(2):123–140. doi:10.1016/S0378-5173(97)00135-X.
   Web of Science ®Google Scholar
• Sharma G, Dhankar G, Thakur K, Raza K, Katare OP. 2016. Benzyl benzoate-loaded microemulsion for topical applications: enhanced dermatokinetic profile and better delivery promises. AAPS PharmSciTech. 17(5):1221–1231. doi:10.1208/s12249-015-0464-0.
   PubMed Web of Science ®Google Scholar
• Suh MS, Kastellorizios M, Tipnis N, Zou Y, Wang Y, Choi S, Burgess DJ. 2021. Effect of implant formation on drug release kinetics of in situ forming implants. Int J Pharm. 592:120105. doi:10.1016/j.ijpharm.2020.120105.
   PubMedGoogle Scholar
• Sun Y, Jensen H, Petersen NJ, Larsen SW, Østergaard J. 2017. Phase separation of in situ forming poly (lactide-co-glycolide acid) implants investigated using a hydrogel-based subcutaneous tissue surrogate and UV–vis imaging. J Pharm Biomed Anal. 145:682–691. doi:10.1016/j.jpba.2017.07.056.
   PubMed Web of Science ®Google Scholar
• Thakur RRS, McMillan HL, Jones DS. 2014. Solvent induced phase inversion-based in situ forming controlled release drug delivery implants. J Controlled Release. 176:8–23. doi:10.1016/j.jconrel.2013.12.020.
   PubMed Web of Science ®Google Scholar
• Vlachopoulos A, Karlioti G, Balla E, Daniilidis V, Kalamas T, Stefanidou M, Bikiaris ND, Christodoulou E, Koumentakou I, Karavas E, et al. 2022. Poly(Lactic Acid)-based microparticles for drug delivery applications: an overview of recent advances. Pharmaceutics. 14(2):359. doi:10.3390/pharmaceutics14020359.
   PubMed Web of Science ®Google Scholar
• Wang L, Kleiner L, Venkatraman S. 2003. Structure formation in injectable poly(lactide–co-glycolide) depots. J Control Release. 90(3):345–354. doi:10.1016/S0168-3659(03)00198-6.
   PubMed Web of Science ®Google Scholar
• Wang L, Lin X, Hong Y, Shen L, Feng Y. 2017. Hydrophobic mixed solvent induced PLGA-based in situ forming systems for smooth long-lasting delivery of radix ophiopogonis polysaccharide in rats. RSC Adv. 7(9):5349–5361. doi:10.1039/C6RA27676H.
   Web of Science ®Google Scholar
• Wang L, Venkatraman S, Kleiner L. 2004. Drug release from injectable depots: two different in vitro mechanisms. J Controlled Release. 99(2):207–216. doi:10.1016/j.jconrel.2004.06.021.
   PubMed Web of Science ®Google Scholar
• Wang L, Wang A, Zhao X, Liu X, Wang D, Sun F, Li Y. 2012. Design of a long-term antipsychotic in situ forming implant and its release control method and mechanism. Int J Pharm. 427(2):284–292. doi:10.1016/j.ijpharm.2012.02.015.
   PubMedGoogle Scholar
• Wei L, Sun P, Nie S, Pan W. 2005. Preparation and evaluation of SEDDS and SMEDDS containing carvedilol. Drug Dev Ind Pharm. 31(8):785–794. doi:10.1080/03639040500216428.
   PubMed Web of Science ®Google Scholar
• Wischke C, Zhang Y, Mittal S, Schwendeman SP. 2010. Development of PLGA-based injectable delivery systems for hydrophobic fenretinide. Pharm Res. 27(10):2063–2074. doi:10.1007/s11095-010-0202-y.
   PubMed Web of Science ®Google Scholar
• Young T-H, Chen L-W. 1995. Pore formation mechanism of membranes from phase inversion process. Desalination. 103(3):233–247. doi:10.1016/0011-9164(95)00076-3.
   Web of Science ®Google Scholar