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      Pharmaceutical amorphous solid dispersion: A review of manufacturing strategies

      review-article
      Author(s): a , b , c , b , b , b , a , b , ∗ , a , ∗
      Publication date (Electronic):
      Journal: Acta Pharmaceutica Sinica. B
      Publisher: Elsevier
      Keywords: Amorphous solid dispersions, Stability, Drug delivery, Manufacturing, Solvent evaporation, Melting process, Co-precipitation, Downstream processing, Selection criteria, ASES, aerosol solvent extraction system, ASDs, amorphous solid dispersions, CAP, cellulose acetate phthalate, CO2, carbon dioxide, scCO2, supercritical CO2, CSG, continuous-spray granulation, EPAS, evaporative aqueous solution precipitation, Eudragit®, polymethacrylates derivatives, FDM, fused deposition modeling, GAS, gas antisolvent, Tg, glass transition temperature, HME, hot-melt extrusion, HPC, hydroxypropyl cellulose, HPMC, hydroxypropyl methylcellulose, HPMCAS, hydroxypropyl methylcellulose acetate succinate, HPMCP, hypromellose phthalate, PCA, precipitation with compressed fluid antisolvent, SAS, supercritical antisolvent, PGSS, precipitation from gas-saturated solutions, PLGA, poly(lactic-co-glycolic acid, PVP, polyvinylpyrrolidone, PVPVA, polyvinylpyrrolidone/vinyl acetate, RESS, rapid expansion of a supercritical solution, SCFs, supercritical fluids, SEDS, solution-enhanced dispersion by SCF, SLS, selective laser sintering, Soluplus®, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, USC, ultrasound compaction, 3DP, three-dimensional printing

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          Abstract

          Amorphous solid dispersions (ASDs) are popular for enhancing the solubility and bioavailability of poorly water-soluble drugs. Various approaches have been employed to produce ASDs and novel techniques are emerging. This review provides an updated overview of manufacturing techniques for preparing ASDs. As physical stability is a critical quality attribute for ASD, the impact of formulation, equipment, and process variables, together with the downstream processing on physical stability of ASDs have been discussed. Selection strategies are proposed to identify suitable manufacturing methods, which may aid in the development of ASDs with satisfactory physical stability.

          Graphical abstract

          The review provides an updated overview of amorphous solid dispersion (ASD) manufacturing techniques. The impact of manufacturing variables of each method and downstream processing on the critical physical stability of ASDs are discussed.

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          Improving drug solubility for oral delivery using solid dispersions.

          C Leuner (2000)
          The solubility behaviour of drugs remains one of the most challenging aspects in formulation development. With the advent of combinatorial chemistry and high throughput screening, the number of poorly water soluble compounds has dramatically increased. Although solid solutions have tremendous potential for improving drug solubility, 40 years of research have resulted in only a few marketed products using this approach. With the introduction of new manufacturing technologies such as hot melt extrusion, it should be possible to overcome problems in scale-up and for this reason solid solutions are enjoying a renaissance. This article begins with an overview of the historical background and definitions of the various systems including eutectic mixtures, solid dispersions and solid solutions. The remainder of the article is devoted to the production, the different carriers and the methods used for the characterization of solid dispersions.
          Article 0 comments Cited 270 times – based on 0 reviews     Review now
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            Effect of geometry on drug release from 3D printed tablets

            Alvaro Goyanes, Pamela Robles Martinez, Asma B.M. Buanz … (2015)
            The aim of this work was to explore the feasibility of combining hot melt extrusion (HME) with 3D printing (3DP) technology, with a view to producing different shaped tablets which would be otherwise difficult to produce using traditional methods. A filament extruder was used to obtain approx. 4% paracetamol loaded filaments of polyvinyl alcohol with characteristics suitable for use in fused-deposition modelling 3DP. Five different tablet geometries were successfully 3D-printed-cube, pyramid, cylinder, sphere and torus. The printing process did not affect the stability of the drug. Drug release from the tablets was not dependent on the surface area but instead on surface area to volume ratio, indicating the influence that geometrical shape has on drug release. An erosion-mediated process controlled drug release. This work has demonstrated the potential of 3DP to manufacture tablet shapes of different geometries, many of which would be challenging to manufacture by powder compaction.
            Article 0 comments Cited 195 times – based on 0 reviews     Review now
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              Polymeric Amorphous Solid Dispersions: A Review of Amorphization, Crystallization, Stabilization, Solid-State Characterization, and Aqueous Solubilization of Biopharmaceutical Classification System Class II Drugs.

              Niall J O'Reilly, Helen Cathcart, Shrawan Baghel (2016)
              Poor water solubility of many drugs has emerged as one of the major challenges in the pharmaceutical world. Polymer-based amorphous solid dispersions have been considered as the major advancement in overcoming limited aqueous solubility and oral absorption issues. The principle drawback of this approach is that they can lack necessary stability and revert to the crystalline form on storage. Significant upfront development is, therefore, required to generate stable amorphous formulations. A thorough understanding of the processes occurring at a molecular level is imperative for the rational design of amorphous solid dispersion products. This review attempts to address the critical molecular and thermodynamic aspects governing the physicochemical properties of such systems. A brief introduction to Biopharmaceutical Classification System, solid dispersions, glass transition, and solubility advantage of amorphous drugs is provided. The objective of this review is to weigh the current understanding of solid dispersion chemistry and to critically review the theoretical, technical, and molecular aspects of solid dispersions (amorphization and crystallization) and potential advantage of polymers (stabilization and solubilization) as inert, hydrophilic, pharmaceutical carrier matrices. In addition, different preformulation tools for the rational selection of polymers, state-of-the-art techniques for preparation and characterization of polymeric amorphous solid dispersions, and drug supersaturation in gastric media are also discussed.
              Article 0 comments Cited 185 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Sumit Kumar
                Qi (Tony) Zhou
                Journal
                Journal ID (nlm-ta): Acta Pharm Sin B
                Journal ID (iso-abbrev): Acta Pharm Sin B
                Title: Acta Pharmaceutica Sinica. B
                Publisher: Elsevier
                ISSN (Print): 2211-3835
                ISSN (Electronic): 2211-3843
                Publication date PMC-release: 05 June 2021
                Publication date (Print): August 2021
                Publication date (Electronic): 05 June 2021
                Volume: 11
                Issue: 8
                Pages: 2505-2536
                Affiliations
                [a ]Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, IN 47907, USA
                [b ]Oral Product Development, Bristol Myers Squibb, Summit, NJ 07901, USA
                [c ]Material Science and Engineering, Bristol Myers Squibb, Summit, NJ 07901, USA
                Author notes
                [∗ ]Corresponding authors. Tel.: +1 217 4167234 (Sumit Kumar); +1 765 4960707 (Qi (Tony) Zhou). sumit.kumar@ 123456bms.com tonyzhou@ 123456purdue.edu
                Article
                Publisher Item ID: S2211-3835(21)00180-5
                DOI: 10.1016/j.apsb.2021.05.014
                PMC ID: 8424289
                PubMed ID: 34522596
                SO-VID: e2318853-5f64-43a8-aab1-607c6b5c6b23
                Copyright © © 2021 Chinese Pharmaceutical Association and Institute of Materia Medica, Chinese Academy of Medical Sciences. Production and hosting by Elsevier B.V.
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 7 February 2021
                Date revision received : 5 April 2021
                Date accepted : 13 April 2021
                Categories
                Subject: Review

                Keywords: amorphous solid dispersions,stability,drug delivery,manufacturing,solvent evaporation,melting process,co-precipitation,downstream processing,selection criteria,ases, aerosol solvent extraction system,asds, amorphous solid dispersions,cap, cellulose acetate phthalate,co2, carbon dioxide,scco2, supercritical co2,csg, continuous-spray granulation,epas, evaporative aqueous solution precipitation,eudragit®, polymethacrylates derivatives,fdm, fused deposition modeling,gas, gas antisolvent,tg, glass transition temperature,hme, hot-melt extrusion,hpc, hydroxypropyl cellulose,hpmc, hydroxypropyl methylcellulose,hpmcas, hydroxypropyl methylcellulose acetate succinate,hpmcp, hypromellose phthalate,pca, precipitation with compressed fluid antisolvent,sas, supercritical antisolvent,pgss, precipitation from gas-saturated solutions,plga, poly(lactic-co-glycolic acid,pvp, polyvinylpyrrolidone,pvpva, polyvinylpyrrolidone/vinyl acetate,ress, rapid expansion of a supercritical solution,scfs, supercritical fluids,seds, solution-enhanced dispersion by scf,sls, selective laser sintering,soluplus®, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer,usc, ultrasound compaction,3dp, three-dimensional printing
                Data availability:
                Keywords: amorphous solid dispersions, stability, drug delivery, manufacturing, solvent evaporation, melting process, co-precipitation, downstream processing, selection criteria, ases, aerosol solvent extraction system, asds, amorphous solid dispersions, cap, cellulose acetate phthalate, co2, carbon dioxide, scco2, supercritical co2, csg, continuous-spray granulation, epas, evaporative aqueous solution precipitation, eudragit®, polymethacrylates derivatives, fdm, fused deposition modeling, gas, gas antisolvent, tg, glass transition temperature, hme, hot-melt extrusion, hpc, hydroxypropyl cellulose, hpmc, hydroxypropyl methylcellulose, hpmcas, hydroxypropyl methylcellulose acetate succinate, hpmcp, hypromellose phthalate, pca, precipitation with compressed fluid antisolvent, sas, supercritical antisolvent, pgss, precipitation from gas-saturated solutions, plga, poly(lactic-co-glycolic acid, pvp, polyvinylpyrrolidone, pvpva, polyvinylpyrrolidone/vinyl acetate, ress, rapid expansion of a supercritical solution, scfs, supercritical fluids, seds, solution-enhanced dispersion by scf, sls, selective laser sintering, soluplus®, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, usc, ultrasound compaction, 3dp, three-dimensional printing

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