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Evaluation of the effect of polymer composition on the rheological, mechanical properties and drug-released behavior of novel Eudragit L100-55/gelatin gastro-resistance uncoated capsule

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Abstract

Capsules have been investigated as a popular oral dosage form among communities due to their simplicity and ease of production. Capsules that are considered in the gastro-resistance category can be very beneficial due to enhanced drug absorption, improved stability, targeted release, etc. This study investigated the effect of enteric polymers on uncoated hard capsule fabrication and dissolution properties. The polymers used in this study included HPMCPh and Eudragit L100-55. Eight different formulations based on HPMCPh, Eudragit, and gelatin were examined to identify the ideal formulation for the product of uncoated enteric hard capsules with preferred physicochemical and gastro-resistance properties. The results reveal that the capsules containing Eudragit (F1), HPMCPh (F2), Eudragit/HPMCPh/gelatin (F3), and Eudragit/gelatin (F4) are steady within the simulated stomach environment, and drug release does not occur for 120 min. The outcomes demonstrate that, among the proposed formulas, the F4 formula is suitable both in terms of capsulation form and delayed-release properties and shows no microbial growth. The properties of the optimized sample were studied by FTIR, FESEM, tensile strength, humidity, and rheology. The results illustrated that gelatin-based hydrogels with Eudragit (F4) are potential candidates for manufacturing uncoated enteric hard capsules that inhibit drug release in a gastric pH medium and act as a pH-sensitive drug-release system.

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Acknowledgements

The authors thank the Iran Gelatin Capsule Mfg Co-IGCC for financing this research.

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Authors and Affiliations

  1. Iran Gelatin Capsule Mfg Co, Tehran, 3351773415, Iran

    Ramin Ramezani Kalmer, Afzal Karimi, Samira Gholizadeh Dogaheh, Mojgan Ghanbari, Dariush Samandarian, Atefeh Sadjadinia, Hamed Ramezanalizadeh & Seyedehmaryam Moosavi

  2. Department of Biotechnology, Faculty of Advanced Technologies in Medicine, Iran University of Medical Sciences, Tehran, 1449614535, Iran

    Afzal Karimi

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  1. Ramin Ramezani Kalmer
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Contributions

CRediT authorship contribution statement: Ramin Ramezani Kalmer was involved in the conceptualization, supervision, project administration, and visualization; Afzal Karimi contributed to the methodology. Samira Gholizadeh Dogaheh assisted in the writing—review and editing, validation, resources, and data curation. Mojgan Ghanbari was involved in the investigation, formal analysis, editing, and software. Dariush Samandarian contributed to the methodology. Atefeh Sadjadinia assisted in the investigation and formal analysis. Hamed Ramezanalizadeh was involved in the data curation, validation, and resources. Seyedehmaryam Moosavi contributed to the investigation and methodology. Notes The authors declare no competing financial interest.

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Correspondence to Ramin Ramezani Kalmer or Samira Gholizadeh Dogaheh.

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Kalmer, R.R., Karimi, A., Dogaheh, S.G. et al. Evaluation of the effect of polymer composition on the rheological, mechanical properties and drug-released behavior of novel Eudragit L100-55/gelatin gastro-resistance uncoated capsule. Polym. Bull. (2024). https://doi.org/10.1007/s00289-024-05201-4

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