Powder formulation is a cornerstone in the pharmaceutical industry, playing a vital role in improving drug efficacy and ensuring optimal therapeutic outcomes. However, traditional formulation methods often face significant challenges, such as poor solubility and low bioavailability, which can limit the effectiveness of many drugs. To address these issues, innovative strategies have emerged, including amorphous solid dispersions (ASDs), nanotechnology, and advanced manufacturing techniques like spray drying and hot melt etrusion. ASDs are particularly promising for enhancing bioavailability, as they help convert poorly soluble drugs into more soluble and absorbable forms. Despite their potential, challenges like long-term stability and large-scale production remain significant hurdles. Nanotechnology further revolutionizes drug delivery, with Solid Lipid Nanoparticles (SLNs) demonstrating exceptional biocompatibility and the capacity for controlled release, making them valuable for targeted therapies. Techniques like spray drying and hot melt extrusion allow for precise formulation, improving drug stability and performance. The review underscores the critical need for ongoing research and innovation to refine these approaches, optimize formulations, and enhance patient outcomes.

Freeze Drying, hot melt extrusionnanoparticle, nanocrystallization, spray drying

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1. Agrawal AM, Dudhedia MS, Zimny E. Hot Melt Extrusion: Development of an Amorphous Solid Dispersion for an Insoluble Drug from Mini-scale to Clinical Scale. AAPS Pharm Sci Tech. 2016;17(1):133–47. doi:10.1208/s12249–015–0425–7.
2. Chopde S, Datir R, Deshmukh G, Dhotre A, Patil M. Nanoparticle formation by nanospray drying & its application in nanoencapsulation of food bioactive ingredients. J Agric Food Res. 2020;2:100085. doi:10.1016/j.jafr.2020.100085.
3. Debnath SK, Saisivam S, Debanth M, Omri A. Development and evaluation of Chitosan nanoparticles based dry powder inhalation formulations of Prothionamide. PLoS One. 2018;13(1): e0190976. doi: 10.1371/journal.pone.0190976.
4. Fitriani L, Haqi A, Zaini E. Preparation and characterization of solid dispersion freeze-dried efavirenz-Polyvinylpyrrolidone K–30. J Adv Pharm Technol Res. 2016;7(3):105–9. doi:10.4103/2231–4040.184592.
5. Joshi K, Chandra A, Jain K, Talegaonkar S. Nanocrystalization: An Emerging Technology to Enhance the Bioavailability of Poorly Soluble Drugs. Pharm Nanotechnol. 2019;7(4):259–78. doi:10.2174/2211738507666190405182524.
6. Liu J, Grohganz H, Löbmann K, Rades T, Hempel NJ. Co–amorphous drug formulations in numbers: Recent advances in co–amorphous drug formulations with focus on co–formability, molar ratio, preparation methods, physical stability, in vitro and in vivo performance, and new formulation strategies. Pharma. 2021;13(3):389. doi:10.3390/pharmaceutics13030389.
7. Luca A. Effect of nanoencapsulation of purified polyphenolic powder on encapsulation efficiency, storage and baking stability [thesis]. Middle East Technical University; 2012.
8. Malamatari M, Charisi A, Malamataris S, Kachrimanis K, Nikolakakis I. Spray drying for the preparation of nanoparticle–based drug formulations as dry powders for inhalation. Processes. 2020;8(7):788. doi:10.3390/pr8070788.
9. Manjunath K, Ready JS, Venkateswarlu V. Solid lipid nanoparticles as drug delivery systems. Methods Find Exp Clin Pharmacol. 2005;27(2):127–44. doi:10.1358/mf.2005.27.2.876286.
10. Santonocito D, Sarpietro MG, Castelli F, Lauro MR, Torrisi C, Russo S. Development of solid lipid nanoparticles as dry powder: characterization and formulation considerations. Mol. 2023;28(4):1545. doi:10.3390/molecules28041545.
11. Shah DS, Moravkar KK, Jha DK, Lonkar V, Amin PD, Chalikwar SS. A concise summary of powder processing methodologies for flow enhancement. Heliyon. 2023;9(6):e16498. doi: 10.1016/j.heliyon. 2023.e16498.
12. Shi Q, Moinuddin SM, Cai T. Advances in coamorphous drug delivery systems. Acta Pharm Sin B. 2019;9(1):19–35. doi: 10.1016/j.apsb.2018.08.002.
13. Szabó E, Galata DL, Vass P, Hirsch E, Csontos I, Marosi G. Continuous formulation approaches of amorphous solid dispersions: Significance of powder flow properties and feeding performance. Pharma. 2019;11(12):654. doi:10.3390/pharmaceutics11120654.
14. Tahir A, Shabir Ahmad R, Imran M, Ahmad MH, Kamran Khan M, Muhammad N. Recent approaches for utilization of food components as nano–encapsulation: A review. Int J Food Prop. 2021;24(1):1074–96. doi:10.1080/10942912.2021.1953067.
15. Valkama E, Haluska O, Lehto VP, Korhonen O, Pajula K. Production and stability of amorphous solid dispersions produced by a Freeze–drying method from DMSO. Int J Pharm. 2021; 606:120902. doi: 10.1016/j.ijpharm.2021.120902.
16. Wang Y, Xu Z, Wu D, Bai J. Current status and prospects of polymer powder 3D printing technologies. Mater. 2020;13(10):2406. doi:10.3390/ma13102406.
17. Yan X, Tong Z, Chen Y, Mo Y, Feng H, Li P. Bioresponsive materials for drug delivery based on carboxymethyl chitosan/poly (γ-glutamic acid) composite microparticles. Mar Drugs. 2017;15(5):127. doi:10.3390/md15050127.
18. Pouton CW. Formulation of poorly water-soluble drugs for oral administration: Physicochemical and physiological issues and the lipid formulation classification system. Eur J Pharm Sci. 2006;29:278–87.
19. Kawabata Y, Wada K, Nakatani M, Yamada S, Onoue S. Formulation design for poorly water–soluble drugs based on biopharmaceutics classification system: Basic approaches and practical applications. Int J Pharm. 2011;420:1–10.
20. Vasconcelos T, Sarmento B, Costa P. Solid dispersions as strategy to improve oral bioavailability of poor water soluble drugs. Drug Discov Today. 2007;12:1068–75.
21. Hoppentocht M, Hagedoorn P, Frijlink HW, de Boer AH. Technological and practical challenges of dry powder inhalers and formulations. Adv Drug Deliv Rev. 2014;75:18–31.
22. Bonaccorso A, Pellitteri R, Ruozi B, Puglia C, Santonocito D, Pignatello R, et al. Curcumin loaded polymeric vs. lipid nanoparticles: Antioxidant effect on normal and hypoxic olfactory ensheathing cells. Nanomater. 2021;11(159):1–15.
23. Luo WC, Beringhs AO, Kim R, Zhang W, Patel SM, Bogner RH. Impact of formulation on the quality and stability of freeze-dried nanoparticles. Eur J Pharm Biopharm. 2021;169:256–67.
24. Kour H, Malik AA, Ahmad N, Wani TA, Kaul RK, Bhat A. Nanotechnology—New lifeline for food industry. Crit Rev Food Sci Nutr. 2015;60(20):1–10.
25. Khare AR, Vasisht N. Nanoencapsulation in the food industry: Technology of the future. In: Gaonkar AG, Vasisht N, Khare AR, Sobel R, editors. Microencapsulation in the Food Industry: A Practical Implementation Guide. London: Academic Press; 2014.151–5.

Powder formulation is a cornerstone in the pharmaceutical industry, playing a vital role in improving drug efficacy and ensuring optimal therapeutic outcomes. However, traditional formulation methods often face significant challenges, such as poor solubility and low bioavailability, which can limit the effectiveness of many drugs. To address these issues, innovative strategies have emerged, including amorphous solid dispersions (ASDs), nanotechnology, and advanced manufacturing techniques like spray drying and hot melt etrusion. ASDs are particularly promising for enhancing bioavailability, as they help convert poorly soluble drugs into more soluble and absorbable forms. Despite their potential, challenges like long-term stability and large-scale production remain significant hurdles. Nanotechnology further revolutionizes drug delivery, with Solid Lipid Nanoparticles (SLNs) demonstrating exceptional biocompatibility and the capacity for controlled release, making them valuable for targeted therapies. Techniques like spray drying and hot melt extrusion allow for precise formulation, improving drug stability and performance. The review underscores the critical need for ongoing research and innovation to refine these approaches, optimize formulations, and enhance patient outcomes.

Freeze Drying, hot melt extrusionnanoparticle, nanocrystallization, spray drying

🔒 This is a subscription article

Full text is available to subscribers and institutional members. Please choose an option below to access it.

1. Agrawal AM, Dudhedia MS, Zimny E. Hot Melt Extrusion: Development of an Amorphous Solid Dispersion for an Insoluble Drug from Mini-scale to Clinical Scale. AAPS Pharm Sci Tech. 2016;17(1):133–47. doi:10.1208/s12249–015–0425–7.
2. Chopde S, Datir R, Deshmukh G, Dhotre A, Patil M. Nanoparticle formation by nanospray drying & its application in nanoencapsulation of food bioactive ingredients. J Agric Food Res. 2020;2:100085. doi:10.1016/j.jafr.2020.100085.
3. Debnath SK, Saisivam S, Debanth M, Omri A. Development and evaluation of Chitosan nanoparticles based dry powder inhalation formulations of Prothionamide. PLoS One. 2018;13(1): e0190976. doi: 10.1371/journal.pone.0190976.
4. Fitriani L, Haqi A, Zaini E. Preparation and characterization of solid dispersion freeze-dried efavirenz-Polyvinylpyrrolidone K–30. J Adv Pharm Technol Res. 2016;7(3):105–9. doi:10.4103/2231–4040.184592.
5. Joshi K, Chandra A, Jain K, Talegaonkar S. Nanocrystalization: An Emerging Technology to Enhance the Bioavailability of Poorly Soluble Drugs. Pharm Nanotechnol. 2019;7(4):259–78. doi:10.2174/2211738507666190405182524.
6. Liu J, Grohganz H, Löbmann K, Rades T, Hempel NJ. Co–amorphous drug formulations in numbers: Recent advances in co–amorphous drug formulations with focus on co–formability, molar ratio, preparation methods, physical stability, in vitro and in vivo performance, and new formulation strategies. Pharma. 2021;13(3):389. doi:10.3390/pharmaceutics13030389.
7. Luca A. Effect of nanoencapsulation of purified polyphenolic powder on encapsulation efficiency, storage and baking stability [thesis]. Middle East Technical University; 2012.
8. Malamatari M, Charisi A, Malamataris S, Kachrimanis K, Nikolakakis I. Spray drying for the preparation of nanoparticle–based drug formulations as dry powders for inhalation. Processes. 2020;8(7):788. doi:10.3390/pr8070788.
9. Manjunath K, Ready JS, Venkateswarlu V. Solid lipid nanoparticles as drug delivery systems. Methods Find Exp Clin Pharmacol. 2005;27(2):127–44. doi:10.1358/mf.2005.27.2.876286.
10. Santonocito D, Sarpietro MG, Castelli F, Lauro MR, Torrisi C, Russo S. Development of solid lipid nanoparticles as dry powder: characterization and formulation considerations. Mol. 2023;28(4):1545. doi:10.3390/molecules28041545.
11. Shah DS, Moravkar KK, Jha DK, Lonkar V, Amin PD, Chalikwar SS. A concise summary of powder processing methodologies for flow enhancement. Heliyon. 2023;9(6):e16498. doi: 10.1016/j.heliyon. 2023.e16498.
12. Shi Q, Moinuddin SM, Cai T. Advances in coamorphous drug delivery systems. Acta Pharm Sin B. 2019;9(1):19–35. doi: 10.1016/j.apsb.2018.08.002.
13. Szabó E, Galata DL, Vass P, Hirsch E, Csontos I, Marosi G. Continuous formulation approaches of amorphous solid dispersions: Significance of powder flow properties and feeding performance. Pharma. 2019;11(12):654. doi:10.3390/pharmaceutics11120654.
14. Tahir A, Shabir Ahmad R, Imran M, Ahmad MH, Kamran Khan M, Muhammad N. Recent approaches for utilization of food components as nano–encapsulation: A review. Int J Food Prop. 2021;24(1):1074–96. doi:10.1080/10942912.2021.1953067.
15. Valkama E, Haluska O, Lehto VP, Korhonen O, Pajula K. Production and stability of amorphous solid dispersions produced by a Freeze–drying method from DMSO. Int J Pharm. 2021; 606:120902. doi: 10.1016/j.ijpharm.2021.120902.
16. Wang Y, Xu Z, Wu D, Bai J. Current status and prospects of polymer powder 3D printing technologies. Mater. 2020;13(10):2406. doi:10.3390/ma13102406.
17. Yan X, Tong Z, Chen Y, Mo Y, Feng H, Li P. Bioresponsive materials for drug delivery based on carboxymethyl chitosan/poly (γ-glutamic acid) composite microparticles. Mar Drugs. 2017;15(5):127. doi:10.3390/md15050127.
18. Pouton CW. Formulation of poorly water-soluble drugs for oral administration: Physicochemical and physiological issues and the lipid formulation classification system. Eur J Pharm Sci. 2006;29:278–87.
19. Kawabata Y, Wada K, Nakatani M, Yamada S, Onoue S. Formulation design for poorly water–soluble drugs based on biopharmaceutics classification system: Basic approaches and practical applications. Int J Pharm. 2011;420:1–10.
20. Vasconcelos T, Sarmento B, Costa P. Solid dispersions as strategy to improve oral bioavailability of poor water soluble drugs. Drug Discov Today. 2007;12:1068–75.
21. Hoppentocht M, Hagedoorn P, Frijlink HW, de Boer AH. Technological and practical challenges of dry powder inhalers and formulations. Adv Drug Deliv Rev. 2014;75:18–31.
22. Bonaccorso A, Pellitteri R, Ruozi B, Puglia C, Santonocito D, Pignatello R, et al. Curcumin loaded polymeric vs. lipid nanoparticles: Antioxidant effect on normal and hypoxic olfactory ensheathing cells. Nanomater. 2021;11(159):1–15.
23. Luo WC, Beringhs AO, Kim R, Zhang W, Patel SM, Bogner RH. Impact of formulation on the quality and stability of freeze-dried nanoparticles. Eur J Pharm Biopharm. 2021;169:256–67.
24. Kour H, Malik AA, Ahmad N, Wani TA, Kaul RK, Bhat A. Nanotechnology—New lifeline for food industry. Crit Rev Food Sci Nutr. 2015;60(20):1–10.
25. Khare AR, Vasisht N. Nanoencapsulation in the food industry: Technology of the future. In: Gaonkar AG, Vasisht N, Khare AR, Sobel R, editors. Microencapsulation in the Food Industry: A Practical Implementation Guide. London: Academic Press; 2014.151–5.