Preview

Regulatory Research and Medicine Evaluation

Advanced search

Pharmacopoeias’ and manufacturers’ requirements for the quality of hard gelatin capsule shells

https://doi.org/10.30895/1991-2919-2024-14-6-620-633

Abstract

INTRODUCTION. The lack of national requirements regulating the quality of empty hard gelatin capsule shells (before filling with medicines) causes difficulties not only for capsule developers and manufacturers but also for experts evaluating regulatory submissions. This necessitates a comparative analysis of Russian and international requirements for the quality of hard gelatin capsule shells in order to draft a pharmacopoeia monograph on empty hard gelatin capsule shells.

AIM. This study aimed to analyse the level of quality requirements for hard gelatin capsule shells, the selection of quality attributes for testing, and the applicable methods and analytical procedures for the preparation of a draft monograph for the State Pharmacopoeia of the Russian Federation.

DISCUSSION. The results of this study indicate that the growing interest of manufacturers in producing capsule formulations is due to a number of features and advantages of this dosage form. Monographs on empty hard gelatin capsule shells are available in the State Pharmacopoeia of the Republic of Belarus, the Indian Pharmacopoeia, the Pharmacopoeia of the People’s Republic of China, the Korean

Pharmacopoeia, and the Japanese Pharmacopoeia. The pharmacopoeial requirements for hard gelatin capsule shells include testing for quality attributes, such as description, identification (gelatin, titanium dioxide, dyes, and preservatives), odour, average capsule mass, disintegration, loss on drying, microbiological quality, impurities (sulfate ash, heavy metals, and arsenic), and preservatives (parabens and sulfur dioxide). Compared with other pharmacopoeias, the pharmacopoeias of Belarus and China provide the most detailed approach to the control of hard gelatin capsule shells. According to the materials of registration dossiers for 65 medicinal products formulated as capsules, the hard gelatin capsule shells that are most frequently used in Russia are produced by eight manufacturers. The specifications of these manufacturers include all the common quality attributes described in the pharmacopoeias and additional tests for arsenic and lubricants.

CONCLUSIONS. The results of this comparative analysis of pharmacopoeial quality standards and manufacturers’ specifications for hard gelatin capsule shells justify the selection of the necessary quality attributes, limits, and requirements for inclusion in the draft monograph on empty hard gelatin capsule shells.

About the Authors

E. L. Kovaleva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Elena L. Kovaleva, Dr. Sci. (Pharm.)

8/2 Petrovsky Blvd, Moscow 127051



O. A. Matveeva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Oksana A. Matveeva

8/2 Petrovsky Blvd, Moscow 127051



V. V. Shelestova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Valentina V. Shelestova, Cand. Sci. (Pharm.)

8/2 Petrovsky Blvd, Moscow 127051



K. A. Balatskaya
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Ksenia A. Balatskaya

8/2 Petrovsky Blvd, Moscow 127051



References

1. Gammel IV, Gorbunova SA. The study of the range of drugs in hard gelatin capsules. Medical Almanac. 2018;(1):121–5 (In Russ.). EDN: YWNRNT

2. Gammel IV, Pyatigorskaya NV, Gorbunova SA. The assortment contour of the Russian pharmaceutical market segment – drugs in hard gelatin capsules. Remedium. 2017;(9):26–30 (In Russ.). https://doi.org/10.21518/1561-5936-2017-9-26-30

3. Stepanova EF, Kim ME, Murzagulova КB, Evseyeva SB. Microcapsules: use prospects in modern pharmaceutical practice. Modern Problems of Science and Education. 2014;(5):767 (In Russ.). EDN: SZVUAZ

4. Jezerska L, Prokes R, Gelnar D, Zegzulka J. Hard gelatine capsules: DEM supported experimental study of particle arrangement effect on properties and vibrational transport behavior. Powder Technol. 2022;405:117525. https://doi.org/10.1016/j.powtec.2022.117525

5. Demchenko DV, Pozharitskaya ON, Shikov AN, Makarov VG. History of the development of the manufacture of capsules. Pharmacy. 2015;(8):47–51 (In Russ.). EDN: VBNYBT

6. Romanova EI, Molokhova EI, Kholov AK, Mysov MV. The creation of the composition of gelatin mass for producing of soft gelatin capsules. Medical Almanac. 2014;(2):135–8 (In Russ.). EDN: SFNOOF

7. Gumerov RKh, Galiullina TN, Tarasova NV, Egorova SN. Hard gelatin capsules as a receptacle of medicines. New Pharmacy. 2002;(10):74–6 (In Russ.).

8. Kudaeva AYu. Production of hard gelatin capsules. Trends in the Development of Science and Education. 2022;(86-3):148–50 (In Russ.). https://doi.org/10.18411/trnio-06-2022-129

9. Yuriyeva IN. Study of influence of technological factors on qualitative indices of fluoxetin tablets and capsules. Perm Medical Journal. 2016;33(1):59–65 (In Russ.). EDN: VOALQR

10. Saenko AYu, Stepanova EF, Petrov AYu, Kool IYa. Pharmaco-technological research of gelatin rectal capsules with cinnarizine. Belgorod State University Scientific Bulletin. Series: Medicine, Pharmacy. 2012;(22):150–4 (In Russ.). EDN: RDUPWH

11. Mironova MM, Kovaleva EL. Comparative analysis of quality assessment requirements for gelatin used in drug production (Review). Pharm Chem J. 2017;50:820–5. https://doi.org/10.1007/s11094-017-1540-4

12. Shatabayeva EO, Mun GA, Shaikhutdinov EM, Khutoryanskiy VV. Gelatin: sources, preparation and application in food and biomedicine. Chemical Bulletin of Kazakh National University. 2020;98(3):28–46 (In Russ.). https://doi.org/10.15328/cb1112

13. Koehl NJ, Shah S, Djouka Tenekam I, Khamiakova T, Sauwen N, Vingerhoets S, et al. Lipid based formulations in hard gelatin and HPMC capsules: a physical compatibility study. Pharm Res. 2021;38(8):1439–54. https://doi.org/10.1007/s11095-021-03088-8

14. Molokhova EI, Ponomareva EI, Sorokina YuV, Alekseeva IV, Ryumina TE, Novikova VV, et al. Experimental substantiation of the composition of gelatin mass for obtaining capsules with essential oils. Drug Development & Registration. 2021;10(4):63–8 (In Russ.). https://doi.org/10.33380/2305-2066-2021-10-4(1)-63-68

15. Asyakina LK, Prosekov AYu, Ulrikh EV, Belova DD. Study of degradation of films and capsules plant analogs pharmaceutical gelatine. Fundamental Research. 2014;(9-11):2369–74 (In Russ.). EDN: SWOJAB

16. Podczeck F, Jones BE, eds. Pharmaceutical capsules. Pharmaceutical Press; 2004.


Supplementary files

Review

For citations:


Kovaleva E.L., Matveeva O.A., Shelestova V.V., Balatskaya K.A. Pharmacopoeias’ and manufacturers’ requirements for the quality of hard gelatin capsule shells. Regulatory Research and Medicine Evaluation. 2024;14(6):620-633. (In Russ.) https://doi.org/10.30895/1991-2919-2024-14-6-620-633

Views: 2150


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 3034-3062 (Print)
ISSN 3034-3453 (Online)