• Aliasgar Shahiwala
  • Ankit Javia
  • Hinal Patel
  • Ambikanandan MisraEmail author


Innovative pharmaceutical companies often look for line extensions for their products as an effective tool toward product life cycle management. Line extensions are incremental innovations that usually enter the market near the expiration of the exclusivity periods of the original product to avoid loss occurring through generic competition. Similarly, other companies changed the profile of patented branded products by demonstrating superiority over the available branded product by using innovative new drug delivery technologies. For industry, repurposing or repositioning of already-approved drugs offers a lower-risk strategy that may reduce both cost and time required to carry the drug to the market. Drug repositioning opportunities can be identified through variety of processes or resources including knowledge mining of present scientific databases, in silico tactics, in vitro/in vivo trials, clinical observations, and post hoc analysis.


  1. 1.
    European Commission Directorate-General For Health and Food Safety Health systems, medical products and innovation Medicines: policy, authorisation and monitoring (n.d.)Google Scholar
  2. 2.
    Sleigh SH, Barton CL (2010) Repurposing strategies for therapeutics. Pharm Med 24:151–159. Scholar
  3. 3.
    Murteira S, Ghezaiel Z, Karray S, Lamure M (2013) Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: reassessment of nomenclature. J Mark Access Heal Policy 1:21131. Scholar
  4. 4.
    Wright P (2014) Modified release formulations give new life to drugs. Pharm Commer. Accessed 15 Oct 2018
  5. 5.
    Husain S (n.d.) Embracing formulation expertise to extend exclusivity & Improve the patient experience|American pharmaceutical review – The review of American pharmaceutical business & technology. Am Pharm Rev. Accessed 15 Oct 2018
  6. 6.
    CFR – Code of Federal Regulations Title 21. US food drug Adm 2018. Accessed 9 Jan 2019
  7. 7.
    Fda, Cder, Ogdp (n.d.) Determining whether to submit an ANDA or a 505(b)(2) Application guidance for industry draft guidanceGoogle Scholar
  8. 8.
    Chokshi N, Modi B (2011) How suitable are the suitability petition and 505(b)(2)? J Generic Med Bus 8:23–27. Scholar
  9. 9.
    Review Practice G (2015) Nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route guidance for industry and review staff good review practiceGoogle Scholar
  10. 10.
    Ich. ICH Topic M 3 (R2) Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals Step 3 note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (cpmp/ich/286/95) non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. 2008Google Scholar
  11. 11.
    International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use nonclinical evaluation for anticancer pharmaceuticals S9 Current Step 4 version (2009)Google Scholar
  12. 12.
    Fda, Cder (n.d.) Generating antibiotic incentives now required by section 805 of the food and drug administration safety and innovation act public law 112–144 Department of Health and Human ServicesGoogle Scholar
  13. 13.
    Kumar S, Singh P (2016) Various techniques for solubility enhancement: an overview 2016. Pharm Innov J 5(1):23–28CrossRefGoogle Scholar
  14. 14.
    Steffe E, Nannenga-Combs B, Longsworth G. The impact of reformulation strategies on pharmaceuticals biologics 2016. Accessed 15 Oct 2018
  15. 15.
    Nanotechnology Cancer Therapy and Treatment – National Cancer Institute (n.d.). Accessed 18 Oct 2018
  16. 16.
    Amiji MM, Vyas TK, Shah LK (2006) Role of nanotechnology in HIV/AIDS treatment: potential to overcome the viral reservoir challenge. Discov Med 6:157–162PubMedGoogle Scholar
  17. 17.
    Vyas TK, Shah L, Amiji MM (2006) Nanoparticulate drug carriers for delivery of HIV/AIDS therapy to viral reservoir sites. Expert Opin Drug Deliv 3:613–628. Scholar
  18. 18.
    Walters KA, Roberts MS (2002) The structure and function of skin. In: Walters KA (ed) Dermatological transdermal formulations. Informa healthcare, New York, pp 1–40CrossRefGoogle Scholar
  19. 19.
    Subedi RK, Oh SY, Chun M-K, Choi H-K (2010) Recent advances in transdermal drug delivery. Arch Pharm Res 33:339–351. Scholar
  20. 20.
    Rouphael NG, Paine M, Mosley R, Henry S, McAllister DV, Kalluri H et al (2017) The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial. Lancet (London, England) 390:649–658. Scholar
  21. 21.
    Wise J (2017) Microneedle patch for flu vaccination proves successful in human clinical trial. BMJ 357:j3120. Scholar
  22. 22.
    Zhang Y, Yu J, Wang J, Hanne NJ, Cui Z, Qian C et al (2017) Thrombin-responsive transcutaneous patch for auto-anticoagulant regulation. Adv Mater 29. Scholar
  23. 23.
    Cipolla DC, Gonda I (2011) Formulation technology to repurpose drugs for inhalation delivery. Drug Discov Today Ther Strateg 8:123–130. Scholar
  24. 24.
    Hohenegger M (2010) Novel and current treatment concepts using pulmonary drug delivery. Curr Pharm Des 16:2484–2492CrossRefGoogle Scholar
  25. 25.
    Patton JS, Byron PR (2007) Inhaling medicines: delivering drugs to the body through the lungs. Nat Rev Drug Discov 6:67–74. Scholar
  26. 26.
    Heinemann L (2008) The failure of exubera: are we beating a dead horse? J Diabetes Sci Technol 2:518–529. Scholar
  27. 27.
    Groneberg DA, Witt C, Wagner U, Chung KF, Fischer A (2003) Fundamentals of pulmonary drug delivery. Respir Med 97:382–387CrossRefGoogle Scholar
  28. 28.
    Chan JGY, Wong J, Zhou QT, Leung SSY, Chan H-K (2014) Advances in device and formulation technologies for pulmonary drug delivery. AAPS PharmSciTech 15:882–897. Scholar
  29. 29.
    Chow AHL, Tong HHY, Chattopadhyay P, Shekunov BY (2007) Particle engineering for pulmonary drug delivery. Pharm Res 24:411–437. Scholar
  30. 30.
    Lipp MM, Sung JC (2016) Cationic dry powders. US 9.433,576 B2Google Scholar
  31. 31.
    Pascolini D, Mariotti SP (2012) Global estimates of visual impairment: 2010. Br J Ophthalmol 96:614–618. Scholar
  32. 32.
    Weijtens O, Schoemaker RC, Romijn FPHTM, Cohen AF, Lentjes EGWM, van Meurs JC (2002) Intraocular penetration and systemic absorption after topical application of dexamethasone disodium phosphate. Ophthalmology 109:1887–1891CrossRefGoogle Scholar
  33. 33.
    Chung S-H, Lim SA, Tchach H (2016) Efficacy and safety of carbomer-based lipid-containing artificial tear formulations in patients with dry eye syndrome. Cornea 35:181–186. Scholar
  34. 34.
    Baudouin C, Labbé A, Liang H, Pauly A, Brignole-Baudouin F (2010) Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res 29:312–334. Scholar
  35. 35.
    Ward AH, Siegwart JT, Frost MR, Norton TT (2016) The effect of intravitreal injection of vehicle solutions on form deprivation myopia in tree shrews. Exp Eye Res 145:289–296. Scholar
  36. 36.
    Patel A, Cholkar K, Agrahari V, Mitra AK (2013) Ocular drug delivery systems: an overview. World J Pharmacol 2:47–64. Scholar
  37. 37.
    Kuno N, Fujii S (2011) Recent advances in ocular drug delivery systems. Polymers (Basel) 3:193–221. Scholar
  38. 38.
    Kourlaba G, Dimopoulos MA, Pectasides D, Skarlos DV, Gogas H, Pentheroudakis G et al (2015) Comparison of filgrastim and pegfilgrastim to prevent neutropenia and maintain dose intensity of adjuvant chemotherapy in patients with breast cancer. Support Care Cancer 23:2045–2051. Scholar
  39. 39.
    Cder (2017) 2017 New drug therapy approvalsGoogle Scholar

Copyright information

© Springer Nature Singapore Pte Ltd. 2019

Authors and Affiliations

  • Aliasgar Shahiwala
    • 1
  • Ankit Javia
    • 2
  • Hinal Patel
    • 3
  • Ambikanandan Misra
    • 2
    Email author
  1. 1.Department of PharmaceuticsDubai Pharmacy CollegeDubaiUAE
  2. 2.Faculty of PharmacyThe Maharaja Sayajirao University of BarodaVadodaraIndia
  3. 3.Kashiv Biosciences LLCAhmedabadIndia

Personalised recommendations