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Journal Cover Journal of Excipients and Food Chemicals
  [SJR: 0.395]   [H-I: 6]   [2 followers]  Follow
    
  This is an Open Access Journal Open Access journal
   ISSN (Print) 21502668
   Published by International Pharmaceutical Excipients Council Homepage  [1 journal]
  • Can excipient analytical testing be 'volkswagenized''

    • Authors: Shireesh Apte
      Pages: 17 - 19
      Abstract: None
      PubDate: 2016-06-29
      Issue No: Vol. 7, No. 2 (2016)
       
  • Maximization of the In Vitro transcorneal release and the In Vivo
           IOP-lowering effects of Latanoprost Ophthalmic gel formulations using
           Azone as a penetration enhancer and Carbopol-974 as a mucoadhesive

    • Authors: Mohsen I. Afouna
      Pages: 20 - 34
      Abstract: The objectives of this study were to maximize; a) the in vitro transcorneal release, b) the IOP-lowering effect and, c) the duration of action, of Latanoprost acid (LAT) ophthalmic gels. Method. The in vitro transcorneal release of LAT from a 1st set of gel formulations that containing different concentrations of Azone™ (as enhancer) with fixed concentration of C-974® (as mucoadhesive) were studied. Then, formulation that showed greatest permeability parameters at lowest Azone™ concentration was selected for preparation of a 2nd set of ocular gels containing various C-974® concentrations. Similarly, their in vitro permeabilities were evaluated, and the best C-974® concentration required for preparation of formulation(s) that can be conceded as ideal ophthalmic LAT gel(s) was pinpointed.  Thereafter, the in vivo IOP-lowering efficacy study for the scaled-up formulations from both sets of the test formulations was conducted using TONO-PEN™ AVIA tonometer in rabbits for 4-consecutive days. Finally, how long such IOP-lowering effect does persist'  To answer this question, the most effective formulations were used for a single-dose study, and the IOP was assessed at predetermined time interval till re-establishing the IOP base-line. Results. Majority of tested formulations have showed significant but varied augmentations in both, in vitro and in vivo results. Formulations (GAZ-4) & GC-4 have shown the highest therapeutic IOP lowering effects; i.e., (7.8±1.8), (6.5±2.1), respectively. Particularly noteworthy with both formulations the IOP base-line didn’t re-established after 24 hours, and their durations of action in the single-dose study were 47±2.25, and 48±1.5, respectively. Conclusion. The in vitro release, onset, magnitude & duration of action of action of LAT gels have been enhanced and extended for up to 2-day with two gel formulations.  Nonetheless, the success in developing a novel ophthalmic formulation depended for great extent upon the crucial net outcomes of a very sensitive interplay/balance between the drug and additives.
      PubDate: 2016-06-29
      Issue No: Vol. 7, No. 2 (2016)
       
  • Mitigating the Risks of Generic Drug Product Development: An Application
           of Quality by Design (QbD) and Question based Review (QbR) Approaches

    • Authors: Manjurul Kader
      Pages: 35 - 75
      Abstract: This paper discusses the challenges and opportunities of implementing the Quality by Design (QbD) and Question based Review (QbR) approaches in developing solid dosage formulations and manufacturing processes for generic drug products. Formulation and process development of a drug product is a challenge due to the inherent variability associated with the activity. Regulatory bodies, such as the Food and Drug Administration (FDA) of the USA, require the QbD approach in developing formulations and processes for drug products. The QbD approach is described in the International Conference on Harmonisation (ICH) guidance Q8 (R2). The regulatory reviewers follow the QbR approach during the review of Chemistry, Manufacturing, and Controls (CMC), which have also adopted some of the elements of the QbD guidance. A systematic application of scientific principles in developing the formulations and processes for generic drug products following the QbD approach is outlined in three main categories. The categories are (A) product understanding, (B) process understanding, and (C) control strategy. The concept of predefined objectives, quality risk management, and CMC considerations along with the prior knowledge are discussed in details. The discussions and explanations provided in this paper are based on sound scientific principles as well as practical experience and approaches applied to resolve product quality and manufacturing issues. Emphasis is given to streamlining the formulations and process development activity to comply with the QbD and QbR principles and to avoid commonly cited deficiencies. The examples are provided as guiding tools for the generic formulation and process development professionals.
      PubDate: 2016-07-16
      Issue No: Vol. 7, No. 2 (2016)
       
 
 
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