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Compatibility Studies of Minoxidil with Different Excipients by Using DSC, TGA and FTIR

Year 2025, Volume: 20 Issue: 1, 10 - 24, 25.05.2025
https://doi.org/10.29233/sdufeffd.1521098

Abstract

This study aims to understand the compatibility or incompatibility of minoxidil with these excipients, which are commonly included in drug formulations for various purposes. The study examined the interaction of minoxidil with several excipients including mannitol, calcium phosphate dibasic, butylated hydroxyanisole, magnesium stearate, cellulose, Beta-cyclodextrin, Eudragit S 100, sodium carboxymethyl cellulose, and talc. Morphological and thermal properties were analyzed using techniques such as DSC, TGA, and FTIR. Minoxidil was found to be compatible with Beta-cyclodextrin, calcium phosphate dibasic, cellulose, and sodium carboxymethyl cellulose. This suggests that these excipients can be used in formulations with minoxidil without causing any adverse interactions. However, minoxidil was found to be incompatible with Eudragit S 100, mannitol, magnesium stearate, and talc. This indicates that these excipients may not be suitable for use in formulations with minoxidil due to potential interactions that could affect stability, safety, efficacy, or quality of the drug dosage form. These findings provide valuable insights for formulators and researchers in the pharmaceutical industry to develop stable and effective formulations containing minoxidil. It underscores the importance of understanding the interactions between active pharmaceutical ingredients and excipients to ensure the quality and performance of drug products.

Project Number

-

References

  • U. Blume-Peytavi, A. Blumeyer, A. Tosti A, A. Finner, V. Marmol, M. Trakatelli, P. Reygagne, A. Messenger, “S1guideline for diagnostic evaluation in androgenetic alopecia in men, women and adolescents”, British Journal of Dermatology, 164(1), 5-15, 2011.
  • T.F. Cash, V.H. Price, R.C. Savin, “Psychological effects of androgenetic alopecia on women: comparisons with balding men and with female control subjects”, Journal of the American Academy of Dermatology, 29, 568-575, 1993.
  • B. M. Piraccini, A. Alessandrini, “Androgenetic alopecia”, Italian Journal of Dermatology and Venereology, 149,15-24, 2014.
  • K. Esen Salman, İ. Kivanc Altunay, N. A. Kucukunal, A. Aksu Cerman, “Frequency, severity and related factors of androgenetic alopecia in dermatology outpatient clinic: hospital-based cross-sectional study in Turkey” Anais Brasileiros de Dermatologia, 92(1), 35-40, 2017.
  • M. Gupta, V. Mysore, “Classifications of patterned hair loss: a review”, Journal of Cutaneous and Aesthetic Surgery, 9, 3-12, 2016.
  • R. D. Subramanya, A. B. Coda, A. A. Sinh, “Transcriptional profiling in alopecia areata defines immune and cell cycle control related genes within disease-specific signatures”, Genomics, 96, 146-153, 2010.
  • M. P. Birch, A. G. Messenger, “Genetic factors predispose to balding and non-balding in men”, European Journal of Dermatology, 11, 309-314, 2001.
  • V. H. Price, “Treatment of hair loss”, New England Journal of Medicine, 341, 964-973, 1999.
  • P. Balakrishnan, S. Shanmugam, W. S. Lee, W. M. Lee, J. O. Kim, D. H. Oh, D. D. Kim, J. S. Kim, B. K. Yoo, H.G. Choi, J. S. Woo, C. S. Yong, “Formulation and in vitro assessment of minoxidil niosomes for enhanced skin delivery”, International Journal of Pharmacology, 377, 1-8, 2009.
  • V. M., Campese, “Minoxidil: a review of its pharmacological properties and therapeutic use”, Drugs, 22(4), 257–278, 1981.
  • P. Suchonwanit, S. Thammarucha, K. Leerunyakul, “Minoxidil and its use in hair disorders: a review”, Drug Design, Development and Therapy, 13, 2777–2786, 2019.
  • A. Rossi, C. Cantisani, L. Melis, A. Iorio, E. Scali, S. Calvieri, “Minoxidil use in dermatology, side effects and recent patents”, Recent Patents on Inflammation & Allergy Drug Discovery, 6(2), 130–136, 2012.
  • R. Parhi, B. R. Terappalli, B. B. Teja, “Formulation and in vitro evaluation of Minoxidil topical gel”, Turkish Journal of Pharmaceutical Sciences ,11(2), 153-162, 2014.
  • A.G. Messenger, J. Rundegren, “Minoxidil: mechanisms of action on hair growth”, British Journal of Dermatology, 150(2), 186–194, 2004.
  • N. Choi, S. Shin, S. U. Song, J. H. Sung, “Minoxidil promotes hair growth through stimulation of growth factor release from adipose-derived stem cells”, International Journal of Molecular Sciences, 19, 691, 2018.
  • E. Vraniæ, “Basic principles of drug-excipients interactions”, Bosnian Journal of Basic Medical Sciences, 4 (2), 56-58, 2004.
  • A. Narang, D. Desai, S. Badawy, “Impact of excipient interactions on solid dosage form stability”, Pharmaceutical Research, 29(10), 2660-2683, 2012.
  • N. Fathima, T. Mamatha, H. K. Qureshi, N. Anitha, J. V. Rao, “Drug-excipient interaction and its importance in dosage form development”, Journal of Applied Pharmaceutical Science, 01(06), 66-71, 2011.
  • F. M. McDaid, S. A., Barker, S. Fitzpatrick, C. R., Petts, D. Q. M. Craig, “Further investigations into the use of high sensitivity differential scanning calorimetry as a means of predicting drugexcipient interactions”, International Journal of Pharmaceutics, 252(1-2), 235-240, 2003.
  • J. T. Carstensen, “Effect of moisture on the stability of solid dosage forms”, Drug Development and Industrial Pharmacy, 14(14), 1927-1969, 1988.
  • D. C. Monkhouse, “Stability aspects of preformulation and formulation of solid pharmaceuticals”, Drug Development and Industrial Pharmacy, 10(8-9), 1373-1412, 1984.
  • S. A. Botha, S. A. Lötter, “Compatibility Study between Naproxen and Tablet Excipients Using Differential Scanning Calorimetry”, Drug Development and Industrial Pharmacy, 16(4), 673-683, 1990.
  • M. E. Brown, E. M. Antunes, B. D. Glass, M. Lebete, R. B. Walker, “DSC screening of potential prochlorperazine-excipient interactions in preformulation studies”, Journal of Thermal Analysis and Calorimetry, 56(3), 1317-1322, 1999.
  • P. C. Mora, M. Cirri, P. Mura, “Differential scanning calorimetry as a screening technique in compatibility studies of DHEA extended release formulations”, Journal of Pharmaceutical and Biomedical Analysis, 42(1), 3-10, 2006.
  • Mura, P., M. T. Faucci, A. Manderioli, G. Bramanti, L. Ceccarelli, “Compatibility study between ibuproxam and pharmaceutical excipients using differential scanning calorimetry, hot-stage microscopy and scanning electron microscopy”, Journal of Pharmaceutical and Biomedical Analysis, 18(1-2), 151-163, 1998.
  • P. Mura, M. T. Faucci, A. Manderioli, G. Bramanti, L. Ceccarelli, “Utilization of differential scanning calorimetry as a screening technique to determine the compatibility of ketoprofen with excipients” International Journal of Pharmaceutics, 119(1), 71-79, 1995.
  • Z. Aigner, Rç Heinrich, e. Sipos, G. Farkas, A. Ciurba, O. Berkesi, P. Szabò-Rèvèsz, “Compatibility studies of aceclofenac with retard tablet excipients by means of thermal and FT-IR spectroscopic methods”, Journal of Thermal Analysis and Calorimetry, 104(1), 265-271, 2011.
  • L. Harding, S. Qi, G. Hill, M. Reading, D. Q. M. Craig, “The development of microthermal analysis and photothermal microspectroscopy as novel approaches to drug-excipient compatibility studies”. International Journal of Pharmaceutics, 354(1-2), 149-157, 2008.
  • M. A. Phipps, R. A. Winnike, S. T. Long, F. Viskomi, “Excipient compatibility as assessed by isothermal microcalorimetry”, Journal of Pharmacy and Pharmacology, 50(S9, 9-9, 1998.
  • G. Pyramides, J. W. Robinson, S. W. Zito, “The combined use of DSC and TGA for the thermal-analysis of Atenolol tablets”, Journal of Pharmaceutical and Biomedical Analysis, 13(2), 103-110, 1995.
  • J. L. Sims, D. J. Carrier, J. A., S. R. Crabtree, “A new approach to accelerated drug-excipient compatibility testing”, Pharmaceutical Development and Technology, 8(2); 119-126, 2003.
  • R. K. Verma, S. Gara, “Compatibility studies between isosorbide mononitrate and selected excipients used in the development of extended release formulations”, Journal of Pharmaceutical and Biomedical Analysis, 35(3); 449-458, 2004.
  • B. V. Joshi, V. B. Patil, V. B. Pokharkar, “Compatibility studies between carbamazepine and tablet excipients using thermal and nonthermal methods”, Drug Development and Industrial Pharmacy, 28, 687–694, 2002.
  • F. Monajjemzadeh, H. Hassanzadeh, V. Valizadeh, M. R. Siahi-Shadbad, J. S. Mojarrad, T. A. Robertson, M. S. Roberts, “Compatibility studies of acyclovir and lactose in physical mixtures and commercial tablets”, The European Journal of Pharmaceutics and Biopharmaceutic, 73, 404–413, 2009.
  • H. Seçilmiş Canbay, M. Doğantürk, “Application of differential scanning calorimetry and fourier transform infrared spectroscopy to the Study of Metoprolol-excipient and Lisinopril-excipient compatibility”, Eurasian Journal of Analytical Chemistry, 13(5), 1-7, 2018.
  • M. Doğantürk, H. Seçilmiş, “Drug-excipient compatibility studies in binary mixtures of Tadalafil by using DSC, TGA and FTIR”, Suleyman Demirel University Journal of Health Sciences, 14(2), 130-141, 2023.
  • M. Lu, H. Xing, T. Yang, J. Yu, Z. Yang, Y. Sun, P. Ding, “Dissolution enhancement of tadalafil by liqui solid technique”, Pharmaceutical Development and Technology, 22(1), 77–89, 2017.
  • Y. Wei, Y. Ling, M. Su, L. Qin, J. Zhang, Y. Gao, S. Qian, “Characterization and stability of amorphous tadalafil and four crystalline polymorphs”, Chemical & Pharmaceutical Bulletin, 66, 1114–1121, 2018.
  • N. R. Pani, L. K. Nath, S. Acharya, “Compatibility studies of nateglinide with excipients in immediate release tablets”, Acta Pharmaceutica, 61(2), 237-247, 2011.
  • M. Manikandan, K. Kannan, R. Manavalan, “Compatibility studies of camptothecin with various pharmaceutical excipients used in the development of nanoparticle formulation”, International Journal of Pharmacy and Pharmaceutical Sciences, 5(4), 315-321, 2013.
  • F. Giordano, C. Novak, J. R. Moyano, “Thermal analysis of cyclodextrins and their inclusion compounds”, Thermochimica Acta, 380(2), 123-151, 2001.
  • H. Abdel-Raouf, U. F. Aly, W. Medhat, S. S. Ahmed, R. T. A. Abdel-Aziz, “A novel topical combination of minoxidil and spironolactone for androgenetic alopecia: Clinical, histopathological, and physicochemical study”, Dermatologic Therapy. 34,14678, 2021.
  • J. Akbari, M. Saeedi, K. M. Semnani, Z. S. Ghadi, S. S. Hosseini “Improving the dissolution properties of spironolactone using liquisolid technique”, Pharmaceutical and Biomedical Research, 1(3),59-70, 2015.
Year 2025, Volume: 20 Issue: 1, 10 - 24, 25.05.2025
https://doi.org/10.29233/sdufeffd.1521098

Abstract

Project Number

-

References

  • U. Blume-Peytavi, A. Blumeyer, A. Tosti A, A. Finner, V. Marmol, M. Trakatelli, P. Reygagne, A. Messenger, “S1guideline for diagnostic evaluation in androgenetic alopecia in men, women and adolescents”, British Journal of Dermatology, 164(1), 5-15, 2011.
  • T.F. Cash, V.H. Price, R.C. Savin, “Psychological effects of androgenetic alopecia on women: comparisons with balding men and with female control subjects”, Journal of the American Academy of Dermatology, 29, 568-575, 1993.
  • B. M. Piraccini, A. Alessandrini, “Androgenetic alopecia”, Italian Journal of Dermatology and Venereology, 149,15-24, 2014.
  • K. Esen Salman, İ. Kivanc Altunay, N. A. Kucukunal, A. Aksu Cerman, “Frequency, severity and related factors of androgenetic alopecia in dermatology outpatient clinic: hospital-based cross-sectional study in Turkey” Anais Brasileiros de Dermatologia, 92(1), 35-40, 2017.
  • M. Gupta, V. Mysore, “Classifications of patterned hair loss: a review”, Journal of Cutaneous and Aesthetic Surgery, 9, 3-12, 2016.
  • R. D. Subramanya, A. B. Coda, A. A. Sinh, “Transcriptional profiling in alopecia areata defines immune and cell cycle control related genes within disease-specific signatures”, Genomics, 96, 146-153, 2010.
  • M. P. Birch, A. G. Messenger, “Genetic factors predispose to balding and non-balding in men”, European Journal of Dermatology, 11, 309-314, 2001.
  • V. H. Price, “Treatment of hair loss”, New England Journal of Medicine, 341, 964-973, 1999.
  • P. Balakrishnan, S. Shanmugam, W. S. Lee, W. M. Lee, J. O. Kim, D. H. Oh, D. D. Kim, J. S. Kim, B. K. Yoo, H.G. Choi, J. S. Woo, C. S. Yong, “Formulation and in vitro assessment of minoxidil niosomes for enhanced skin delivery”, International Journal of Pharmacology, 377, 1-8, 2009.
  • V. M., Campese, “Minoxidil: a review of its pharmacological properties and therapeutic use”, Drugs, 22(4), 257–278, 1981.
  • P. Suchonwanit, S. Thammarucha, K. Leerunyakul, “Minoxidil and its use in hair disorders: a review”, Drug Design, Development and Therapy, 13, 2777–2786, 2019.
  • A. Rossi, C. Cantisani, L. Melis, A. Iorio, E. Scali, S. Calvieri, “Minoxidil use in dermatology, side effects and recent patents”, Recent Patents on Inflammation & Allergy Drug Discovery, 6(2), 130–136, 2012.
  • R. Parhi, B. R. Terappalli, B. B. Teja, “Formulation and in vitro evaluation of Minoxidil topical gel”, Turkish Journal of Pharmaceutical Sciences ,11(2), 153-162, 2014.
  • A.G. Messenger, J. Rundegren, “Minoxidil: mechanisms of action on hair growth”, British Journal of Dermatology, 150(2), 186–194, 2004.
  • N. Choi, S. Shin, S. U. Song, J. H. Sung, “Minoxidil promotes hair growth through stimulation of growth factor release from adipose-derived stem cells”, International Journal of Molecular Sciences, 19, 691, 2018.
  • E. Vraniæ, “Basic principles of drug-excipients interactions”, Bosnian Journal of Basic Medical Sciences, 4 (2), 56-58, 2004.
  • A. Narang, D. Desai, S. Badawy, “Impact of excipient interactions on solid dosage form stability”, Pharmaceutical Research, 29(10), 2660-2683, 2012.
  • N. Fathima, T. Mamatha, H. K. Qureshi, N. Anitha, J. V. Rao, “Drug-excipient interaction and its importance in dosage form development”, Journal of Applied Pharmaceutical Science, 01(06), 66-71, 2011.
  • F. M. McDaid, S. A., Barker, S. Fitzpatrick, C. R., Petts, D. Q. M. Craig, “Further investigations into the use of high sensitivity differential scanning calorimetry as a means of predicting drugexcipient interactions”, International Journal of Pharmaceutics, 252(1-2), 235-240, 2003.
  • J. T. Carstensen, “Effect of moisture on the stability of solid dosage forms”, Drug Development and Industrial Pharmacy, 14(14), 1927-1969, 1988.
  • D. C. Monkhouse, “Stability aspects of preformulation and formulation of solid pharmaceuticals”, Drug Development and Industrial Pharmacy, 10(8-9), 1373-1412, 1984.
  • S. A. Botha, S. A. Lötter, “Compatibility Study between Naproxen and Tablet Excipients Using Differential Scanning Calorimetry”, Drug Development and Industrial Pharmacy, 16(4), 673-683, 1990.
  • M. E. Brown, E. M. Antunes, B. D. Glass, M. Lebete, R. B. Walker, “DSC screening of potential prochlorperazine-excipient interactions in preformulation studies”, Journal of Thermal Analysis and Calorimetry, 56(3), 1317-1322, 1999.
  • P. C. Mora, M. Cirri, P. Mura, “Differential scanning calorimetry as a screening technique in compatibility studies of DHEA extended release formulations”, Journal of Pharmaceutical and Biomedical Analysis, 42(1), 3-10, 2006.
  • Mura, P., M. T. Faucci, A. Manderioli, G. Bramanti, L. Ceccarelli, “Compatibility study between ibuproxam and pharmaceutical excipients using differential scanning calorimetry, hot-stage microscopy and scanning electron microscopy”, Journal of Pharmaceutical and Biomedical Analysis, 18(1-2), 151-163, 1998.
  • P. Mura, M. T. Faucci, A. Manderioli, G. Bramanti, L. Ceccarelli, “Utilization of differential scanning calorimetry as a screening technique to determine the compatibility of ketoprofen with excipients” International Journal of Pharmaceutics, 119(1), 71-79, 1995.
  • Z. Aigner, Rç Heinrich, e. Sipos, G. Farkas, A. Ciurba, O. Berkesi, P. Szabò-Rèvèsz, “Compatibility studies of aceclofenac with retard tablet excipients by means of thermal and FT-IR spectroscopic methods”, Journal of Thermal Analysis and Calorimetry, 104(1), 265-271, 2011.
  • L. Harding, S. Qi, G. Hill, M. Reading, D. Q. M. Craig, “The development of microthermal analysis and photothermal microspectroscopy as novel approaches to drug-excipient compatibility studies”. International Journal of Pharmaceutics, 354(1-2), 149-157, 2008.
  • M. A. Phipps, R. A. Winnike, S. T. Long, F. Viskomi, “Excipient compatibility as assessed by isothermal microcalorimetry”, Journal of Pharmacy and Pharmacology, 50(S9, 9-9, 1998.
  • G. Pyramides, J. W. Robinson, S. W. Zito, “The combined use of DSC and TGA for the thermal-analysis of Atenolol tablets”, Journal of Pharmaceutical and Biomedical Analysis, 13(2), 103-110, 1995.
  • J. L. Sims, D. J. Carrier, J. A., S. R. Crabtree, “A new approach to accelerated drug-excipient compatibility testing”, Pharmaceutical Development and Technology, 8(2); 119-126, 2003.
  • R. K. Verma, S. Gara, “Compatibility studies between isosorbide mononitrate and selected excipients used in the development of extended release formulations”, Journal of Pharmaceutical and Biomedical Analysis, 35(3); 449-458, 2004.
  • B. V. Joshi, V. B. Patil, V. B. Pokharkar, “Compatibility studies between carbamazepine and tablet excipients using thermal and nonthermal methods”, Drug Development and Industrial Pharmacy, 28, 687–694, 2002.
  • F. Monajjemzadeh, H. Hassanzadeh, V. Valizadeh, M. R. Siahi-Shadbad, J. S. Mojarrad, T. A. Robertson, M. S. Roberts, “Compatibility studies of acyclovir and lactose in physical mixtures and commercial tablets”, The European Journal of Pharmaceutics and Biopharmaceutic, 73, 404–413, 2009.
  • H. Seçilmiş Canbay, M. Doğantürk, “Application of differential scanning calorimetry and fourier transform infrared spectroscopy to the Study of Metoprolol-excipient and Lisinopril-excipient compatibility”, Eurasian Journal of Analytical Chemistry, 13(5), 1-7, 2018.
  • M. Doğantürk, H. Seçilmiş, “Drug-excipient compatibility studies in binary mixtures of Tadalafil by using DSC, TGA and FTIR”, Suleyman Demirel University Journal of Health Sciences, 14(2), 130-141, 2023.
  • M. Lu, H. Xing, T. Yang, J. Yu, Z. Yang, Y. Sun, P. Ding, “Dissolution enhancement of tadalafil by liqui solid technique”, Pharmaceutical Development and Technology, 22(1), 77–89, 2017.
  • Y. Wei, Y. Ling, M. Su, L. Qin, J. Zhang, Y. Gao, S. Qian, “Characterization and stability of amorphous tadalafil and four crystalline polymorphs”, Chemical & Pharmaceutical Bulletin, 66, 1114–1121, 2018.
  • N. R. Pani, L. K. Nath, S. Acharya, “Compatibility studies of nateglinide with excipients in immediate release tablets”, Acta Pharmaceutica, 61(2), 237-247, 2011.
  • M. Manikandan, K. Kannan, R. Manavalan, “Compatibility studies of camptothecin with various pharmaceutical excipients used in the development of nanoparticle formulation”, International Journal of Pharmacy and Pharmaceutical Sciences, 5(4), 315-321, 2013.
  • F. Giordano, C. Novak, J. R. Moyano, “Thermal analysis of cyclodextrins and their inclusion compounds”, Thermochimica Acta, 380(2), 123-151, 2001.
  • H. Abdel-Raouf, U. F. Aly, W. Medhat, S. S. Ahmed, R. T. A. Abdel-Aziz, “A novel topical combination of minoxidil and spironolactone for androgenetic alopecia: Clinical, histopathological, and physicochemical study”, Dermatologic Therapy. 34,14678, 2021.
  • J. Akbari, M. Saeedi, K. M. Semnani, Z. S. Ghadi, S. S. Hosseini “Improving the dissolution properties of spironolactone using liquisolid technique”, Pharmaceutical and Biomedical Research, 1(3),59-70, 2015.
There are 43 citations in total.

Details

Primary Language English
Subjects Instrumental Methods
Journal Section Makaleler
Authors

Hale Seçilmiş 0000-0002-3783-8064

Ramazan Altınkaya 0000-0003-2325-3206

Mahmut Doğantürk 0000-0003-1133-6792

Project Number -
Publication Date May 25, 2025
Submission Date July 23, 2024
Acceptance Date January 31, 2025
Published in Issue Year 2025 Volume: 20 Issue: 1

Cite

IEEE H. Seçilmiş, R. Altınkaya, and M. Doğantürk, “Compatibility Studies of Minoxidil with Different Excipients by Using DSC, TGA and FTIR”, Süleyman Demirel University Faculty of Arts and Science Journal of Science, vol. 20, no. 1, pp. 10–24, 2025, doi: 10.29233/sdufeffd.1521098.