Preformulation Study of an Antipsychotic Drug Aripiperazole

Subhasri Mohapatra

doi:doi:10.11648/j.ijmri.20250101.17

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Preformulation Study of an Antipsychotic Drug Aripiperazole

Subhasri Mohapatra^*

Published in International Journal of Medical Research and Innovation (Volume 1, Issue 1)

Received: 8 September 2025 Accepted: 13 October 2025 Published: 19 December 2025

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Abstract

Aripiperazole is an atypical antipsychotic belongs to BCS Class IV, hygroscopic drug used in the treatment of schizophrenia, bipolar disorder, and major depressive disorder also helps to balance dopamine and serotonin levels in the brain with potentially fewer side effects like weight gain. So It has low risk of hyperprolactemia and lower incidence of sedation, Due to this reason doctors and patients often prefer it This comprehensive preformulation study aims to investigate the physicochemical properties of aripiprazole and evaluate its behavior under various conditions relevant to pharmaceutical formulation development. To understand its physical and chemical properties to develop a safe effective and stable dosage form using this drug aripiperazole. Its preformulation study is require. The preformulation study encompasses solubility analysis, stability assessment, particle size distribution, polymorphism, hygroscopicity, and compatibility with common excipients e.g Magnesium stearate, Polyvinyl pyrollidone K30, Lactose monohydrate, Microcrystalline cellulose. Results indicate that aripiprazole exhibits poor aqueous solubility, with pH-dependent solubility profiles. Stability studies reveal sensitivity to light and elevated temperatures. Particle size analysis shows a tendency for agglomeration, while polymorphic studies confirm the existence of multiple crystal forms. Hygroscopicity tests demonstrate minimal moisture uptake under standard conditions. Excipient compatibility studies identify potential interactions with certain additives like Magnesium stearate and Polyvinyl pyrollidone K30 exhibiting a conclusion that during formulation aripiperazole needs special attention and care as well standard optimization studies which can be proved as useful side effect reduction. These findings provide crucial insights for the development of stable, effective formulations of aripiprazole, paving the way for improved drug delivery systems and therapeutic outcomes.

Published in	International Journal of Medical Research and Innovation (Volume 1, Issue 1)
DOI	10.11648/j.ijmri.20250101.17
Page(s)	53-60
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2025. Published by Science Publishing Group

Keywords

Aripiperazole, Preformulation, Solubility, Stability, Particle Size, Polymorphism, Hygroscopicity, Excipient Compatibility

References

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[2]	Swainston Harrison, T.; Perry, C. M. Aripiprazole: a review of its use in schizophrenia and schizoaffective disorder. Drugs 2004, 64, 1715-1736.
[3]	Shapiro, D. A.; Renock, S.; Arrington, E.; Chiodo, L. A.; Liu, L. X.; Sibley, D. R.; Roth, B. L.; Mailman, R. Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology. Neuropsychopharmacology 2003, 28, 1400-1411.
[4]	Citrome, L. A review of aripiprazole in the treatment of patients with schizophrenia or bipolar I disorder. Neuropsychiatr. Dis. Treat. 2006, 2, 427-443.
[5]	Özgüney, I.; Güngör, S.; Karasulu, H. Y.; Baykara, T. Preparation and characterization of polymeric particles for controlled release applications of a water-insoluble drug: aripiprazole. J. Microencapsul. 2007, 24, 749-761.
[6]	Aakeröy, C. B.; Forbes, S.; Desper, J. Using cocrystals to systematically modulate aqueous solubility and melting behavior of an anticancer drug. J. Am. Chem. Soc. 2009, 131, 17048-17049.
[7]	Prado, L. D.; Rocha, H. V. A.; Resende, J. A. L. C.; Ferreira, G. B.; de Figueiredo Teixeira, A. M. R. An insight into carbamazepine crystal forms: effect of pH and ethanol on the suspension crystallization and polymorphic transformation. Cryst. Growth Des. 2014, 14, 1272-1280.
[8]	Avdeef, A. Solubility of sparingly-soluble ionizable drugs. Adv. Drug Deliv. Rev. 2007, 59, 568-590.
[9]	ICH Harmonised Tripartite Guideline. Stability Testing: Photostability Testing of New Drug Substances and Products Q1B. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996.
[10]	European Pharmacopoeia. 5.11. Characters Section in Monographs. 10th ed.; European Directorate for the Quality of Medicines & HealthCare: Strasbourg, France, 2019.
[11]	Alhalaweh, A.; Roy, L.; Rodríguez-Hornedo, N.; Velaga, S. P. pH-dependent solubility of indomethacin-saccharin and carbamazepine-saccharin cocrystals in aqueous media. Mol. Pharm. 2012, 9, 2605-2612.
[12]	Reutzel-Edens, S. M.; Bush, J. K.; Magee, P. A.; Stephenson, G. A.; Byrn, S. R. Anhydrates and hydrates of olanzapine: crystallization, solid-state characterization, and structural relationships. Cryst. Growth Des. 2003, 3, 897-907.
[13]	Samas, B.; Wang, W.; Godrej, D. B. Polymorphism of aripiprazole. U.S. Patent 7,375,111, May 20, 2008.
[14]	Braun, D. E.; Gelbrich, T.; Kahlenberg, V.; Laus, G.; Wieser, J.; Griesser, U. J. Packing polymorphism of a conformationally flexible molecule: the case of aripiprazole. Cryst. Growth Des. 2014, 14, 4895-4900.
[15]	Suresh, K.; Mannava, M. K. C.; Nangia, A. A novel curcumin-artemisinin coamorphous solid: physical properties and pharmacokinetic profile. RSC Adv. 2014, 4, 58357-58361.
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Mohapatra, S. (2025). Preformulation Study of an Antipsychotic Drug Aripiperazole. International Journal of Medical Research and Innovation, 1(1), 53-60. https://doi.org/10.11648/j.ijmri.20250101.17

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ACS Style

Mohapatra, S. Preformulation Study of an Antipsychotic Drug Aripiperazole. Int. J. Med. Res. Innovation 2025, 1(1), 53-60. doi: 10.11648/j.ijmri.20250101.17

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AMA Style

Mohapatra S. Preformulation Study of an Antipsychotic Drug Aripiperazole. Int J Med Res Innovation. 2025;1(1):53-60. doi: 10.11648/j.ijmri.20250101.17

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@article{10.11648/j.ijmri.20250101.17,
  author = {Subhasri Mohapatra},
  title = {Preformulation Study of an Antipsychotic Drug Aripiperazole},
  journal = {International Journal of Medical Research and Innovation},
  volume = {1},
  number = {1},
  pages = {53-60},
  doi = {10.11648/j.ijmri.20250101.17},
  url = {https://doi.org/10.11648/j.ijmri.20250101.17},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijmri.20250101.17},
  abstract = {Aripiperazole is an atypical antipsychotic belongs to BCS Class IV, hygroscopic drug used in the treatment of schizophrenia, bipolar disorder, and major depressive disorder also helps to balance dopamine and serotonin levels in the brain with potentially fewer side effects like weight gain. So It has low risk of hyperprolactemia and lower incidence of sedation, Due to this reason doctors and patients often prefer it This comprehensive preformulation study aims to investigate the physicochemical properties of aripiprazole and evaluate its behavior under various conditions relevant to pharmaceutical formulation development. To understand its physical and chemical properties to develop a safe effective and stable dosage form using this drug aripiperazole. Its preformulation study is require. The preformulation study encompasses solubility analysis, stability assessment, particle size distribution, polymorphism, hygroscopicity, and compatibility with common excipients e.g Magnesium stearate, Polyvinyl pyrollidone K30, Lactose monohydrate, Microcrystalline cellulose. Results indicate that aripiprazole exhibits poor aqueous solubility, with pH-dependent solubility profiles. Stability studies reveal sensitivity to light and elevated temperatures. Particle size analysis shows a tendency for agglomeration, while polymorphic studies confirm the existence of multiple crystal forms. Hygroscopicity tests demonstrate minimal moisture uptake under standard conditions. Excipient compatibility studies identify potential interactions with certain additives like Magnesium stearate and Polyvinyl pyrollidone K30 exhibiting a conclusion that during formulation aripiperazole needs special attention and care as well standard optimization studies which can be proved as useful side effect reduction. These findings provide crucial insights for the development of stable, effective formulations of aripiprazole, paving the way for improved drug delivery systems and therapeutic outcomes.},
 year = {2025}
}

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TY  - JOUR
T1  - Preformulation Study of an Antipsychotic Drug Aripiperazole
AU  - Subhasri Mohapatra
Y1  - 2025/12/19
PY  - 2025
N1  - https://doi.org/10.11648/j.ijmri.20250101.17
DO  - 10.11648/j.ijmri.20250101.17
T2  - International Journal of Medical Research and Innovation
JF  - International Journal of Medical Research and Innovation
JO  - International Journal of Medical Research and Innovation
SP  - 53
EP  - 60
PB  - Science Publishing Group
UR  - https://doi.org/10.11648/j.ijmri.20250101.17
AB  - Aripiperazole is an atypical antipsychotic belongs to BCS Class IV, hygroscopic drug used in the treatment of schizophrenia, bipolar disorder, and major depressive disorder also helps to balance dopamine and serotonin levels in the brain with potentially fewer side effects like weight gain. So It has low risk of hyperprolactemia and lower incidence of sedation, Due to this reason doctors and patients often prefer it This comprehensive preformulation study aims to investigate the physicochemical properties of aripiprazole and evaluate its behavior under various conditions relevant to pharmaceutical formulation development. To understand its physical and chemical properties to develop a safe effective and stable dosage form using this drug aripiperazole. Its preformulation study is require. The preformulation study encompasses solubility analysis, stability assessment, particle size distribution, polymorphism, hygroscopicity, and compatibility with common excipients e.g Magnesium stearate, Polyvinyl pyrollidone K30, Lactose monohydrate, Microcrystalline cellulose. Results indicate that aripiprazole exhibits poor aqueous solubility, with pH-dependent solubility profiles. Stability studies reveal sensitivity to light and elevated temperatures. Particle size analysis shows a tendency for agglomeration, while polymorphic studies confirm the existence of multiple crystal forms. Hygroscopicity tests demonstrate minimal moisture uptake under standard conditions. Excipient compatibility studies identify potential interactions with certain additives like Magnesium stearate and Polyvinyl pyrollidone K30 exhibiting a conclusion that during formulation aripiperazole needs special attention and care as well standard optimization studies which can be proved as useful side effect reduction. These findings provide crucial insights for the development of stable, effective formulations of aripiprazole, paving the way for improved drug delivery systems and therapeutic outcomes.
VL  - 1
IS  - 1
ER  -

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Author Information

Subhasri Mohapatra

Department of pharmaceutics, Royal College of Pharmacy, Raipu, India

Contact Email

http://orcid.org/0009-0005-1869-2919

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APA Style

Mohapatra, S. (2025). Preformulation Study of an Antipsychotic Drug Aripiperazole. International Journal of Medical Research and Innovation, 1(1), 53-60. https://doi.org/10.11648/j.ijmri.20250101.17

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ACS Style

Mohapatra, S. Preformulation Study of an Antipsychotic Drug Aripiperazole. Int. J. Med. Res. Innovation 2025, 1(1), 53-60. doi: 10.11648/j.ijmri.20250101.17

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AMA Style

Mohapatra S. Preformulation Study of an Antipsychotic Drug Aripiperazole. Int J Med Res Innovation. 2025;1(1):53-60. doi: 10.11648/j.ijmri.20250101.17

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@article{10.11648/j.ijmri.20250101.17,
  author = {Subhasri Mohapatra},
  title = {Preformulation Study of an Antipsychotic Drug Aripiperazole},
  journal = {International Journal of Medical Research and Innovation},
  volume = {1},
  number = {1},
  pages = {53-60},
  doi = {10.11648/j.ijmri.20250101.17},
  url = {https://doi.org/10.11648/j.ijmri.20250101.17},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijmri.20250101.17},
  abstract = {Aripiperazole is an atypical antipsychotic belongs to BCS Class IV, hygroscopic drug used in the treatment of schizophrenia, bipolar disorder, and major depressive disorder also helps to balance dopamine and serotonin levels in the brain with potentially fewer side effects like weight gain. So It has low risk of hyperprolactemia and lower incidence of sedation, Due to this reason doctors and patients often prefer it This comprehensive preformulation study aims to investigate the physicochemical properties of aripiprazole and evaluate its behavior under various conditions relevant to pharmaceutical formulation development. To understand its physical and chemical properties to develop a safe effective and stable dosage form using this drug aripiperazole. Its preformulation study is require. The preformulation study encompasses solubility analysis, stability assessment, particle size distribution, polymorphism, hygroscopicity, and compatibility with common excipients e.g Magnesium stearate, Polyvinyl pyrollidone K30, Lactose monohydrate, Microcrystalline cellulose. Results indicate that aripiprazole exhibits poor aqueous solubility, with pH-dependent solubility profiles. Stability studies reveal sensitivity to light and elevated temperatures. Particle size analysis shows a tendency for agglomeration, while polymorphic studies confirm the existence of multiple crystal forms. Hygroscopicity tests demonstrate minimal moisture uptake under standard conditions. Excipient compatibility studies identify potential interactions with certain additives like Magnesium stearate and Polyvinyl pyrollidone K30 exhibiting a conclusion that during formulation aripiperazole needs special attention and care as well standard optimization studies which can be proved as useful side effect reduction. These findings provide crucial insights for the development of stable, effective formulations of aripiprazole, paving the way for improved drug delivery systems and therapeutic outcomes.},
 year = {2025}
}

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TY  - JOUR
T1  - Preformulation Study of an Antipsychotic Drug Aripiperazole
AU  - Subhasri Mohapatra
Y1  - 2025/12/19
PY  - 2025
N1  - https://doi.org/10.11648/j.ijmri.20250101.17
DO  - 10.11648/j.ijmri.20250101.17
T2  - International Journal of Medical Research and Innovation
JF  - International Journal of Medical Research and Innovation
JO  - International Journal of Medical Research and Innovation
SP  - 53
EP  - 60
PB  - Science Publishing Group
UR  - https://doi.org/10.11648/j.ijmri.20250101.17
AB  - Aripiperazole is an atypical antipsychotic belongs to BCS Class IV, hygroscopic drug used in the treatment of schizophrenia, bipolar disorder, and major depressive disorder also helps to balance dopamine and serotonin levels in the brain with potentially fewer side effects like weight gain. So It has low risk of hyperprolactemia and lower incidence of sedation, Due to this reason doctors and patients often prefer it This comprehensive preformulation study aims to investigate the physicochemical properties of aripiprazole and evaluate its behavior under various conditions relevant to pharmaceutical formulation development. To understand its physical and chemical properties to develop a safe effective and stable dosage form using this drug aripiperazole. Its preformulation study is require. The preformulation study encompasses solubility analysis, stability assessment, particle size distribution, polymorphism, hygroscopicity, and compatibility with common excipients e.g Magnesium stearate, Polyvinyl pyrollidone K30, Lactose monohydrate, Microcrystalline cellulose. Results indicate that aripiprazole exhibits poor aqueous solubility, with pH-dependent solubility profiles. Stability studies reveal sensitivity to light and elevated temperatures. Particle size analysis shows a tendency for agglomeration, while polymorphic studies confirm the existence of multiple crystal forms. Hygroscopicity tests demonstrate minimal moisture uptake under standard conditions. Excipient compatibility studies identify potential interactions with certain additives like Magnesium stearate and Polyvinyl pyrollidone K30 exhibiting a conclusion that during formulation aripiperazole needs special attention and care as well standard optimization studies which can be proved as useful side effect reduction. These findings provide crucial insights for the development of stable, effective formulations of aripiprazole, paving the way for improved drug delivery systems and therapeutic outcomes.
VL  - 1
IS  - 1
ER  -

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