Currently, there is a growing need to prepare small batches of enteric capsules for individual therapy or clinical evaluation since many acidic-sensitive substances should be protected from the stomach's acidic environment, including probiotics or fecal material, in the fecal microbiota transplantation (FMT) process. A suitable method seems to be the encapsulation of drugs or lyophilized alternatively frozen biological suspensions in commercial hard enteric capsules prepared by so-called Enteric Capsule Drug Delivery Technology (ECDDT). Manufacturers supply these types of capsules, made from pH-soluble polymers, in products such as AR Caps®, EnTRinsicTM, and Vcaps® Enteric, or capsules made of gelling polymers that release their content as the gel erodes over time when passing through the digestive tract. These include DRcaps®, EMBO CAPS® AP, BioVXR®, or ACGcaps™ HD. Although not all capsules in all formulations meet pharmaceutical requirements for delayed-release dosage forms in disintegration and dissolution tests, they usually find practical application. This literature review presents their composition and properties. Since ECDDT is a new technology, this article is based on a limited number of references.

Department of Pharmaceutical Technology Faculty of Pharmacy Masaryk University 612 42 Brno Czech Republic

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Stegemann S., Tian W., Morgen M., Brown S. Hard Capsules in Modern Drug Delivery. In: Tovey G.D., editor. Pharmaceutical Formulation: The Science and Technology of Dosage Forms. 1st ed. Royal Society of Chemistry; London, UK: 2018. DOI

Overgaard A.B.A., Møller-Sonnergaard J., Christrup L.L., Højsted J., Hansen R. Patients’ Evaluation of Shape, Size and Colour of Solid Dosage Forms. Pharm. World Sci. 2001;23:185–188. doi: 10.1023/A:1012050931018. PubMed DOI

Augsburger L.L. Pharmaceutical Dosage Forms. In: Augsburger L.L., Hoag S.W., editors. Pharmaceutical Dosage Forms. CRC Press; Boca Raton, FL, USA: London, UK: 2017. DOI

Franc A., Kubová K., Elbl J., Muselík J., Vetchý D., Šaloun J., Opatřilová R. Diazepam Filled Hard Capsules Intended for Detoxification of Patients Addicted to Benzodiazepines and Z-Drugs. Eur. J. Hosp. Pharm. 2019;26:10–15. doi: 10.1136/ejhpharm-2016-001163. PubMed DOI PMC

Hannula A.M., Marvola M., Kopra T. Release of Ibuprofen from Hard Gelatin Capsule Formulations: Effect of Various Additives and Filling Method. Acta Pharm. 1989;98

Nair R., Vemuri M., Agrawala P., Kim S. Investigation of Various Factors Affecting Encapsulation on the In-Cap Automatic Capsule-Filling Machine. [(accessed on 19 September 2022)];AAPS PharmSciTech. 2004 5:46–53. doi: 10.1208/pt050457. Available online: https://link.springer.com/content/pdf/10.1208/pt050457.pdf. PubMed DOI PMC

Gullapalli R.P., Mazzitelli C.L. Gelatin and Non-Gelatin Capsule Dosage Forms. J. Pharm. Sci. 2017;106:1453–1465. doi: 10.1016/j.xphs.2017.02.006. PubMed DOI

Sabadková D., Franc A., Muselík J., Neumann D., Vetchý D. Pulsatile Drug Delivery Systems. [(accessed on 19 September 2022)];Chem. Listy. 2015 109:353–359. Available online: http://www.chemicke-listy.cz/ojs3/index.php/chemicke-listy/article/view/369.

Sivert A., Wald R., Craig C., Benameur H. Oral Drug Delivery for Modified Release Formulations. Wiley; Hoboken, NJ, USA: 2022. [(accessed on 10 October 2022)]. Strategies for Modified Release Oral Formulation Development; pp. 235–252. Available online: https://onlinelibrary.wiley.com/doi/abs/10.1002/9781119772729.ch13. DOI

Bhutiani N., Schucht J.E., Miller K.R., McClave S.A. Technical Aspects of Fecal Microbial Transplantation (FMT) Curr. Gastroenterol. Rep. 2018;20:30. doi: 10.1007/s11894-018-0636-7. PubMed DOI

Dvořáčková K., Franc A., Kejdušová M. Drug Delivery to the Large Intesine. [(accessed on 29 September 2022)];Chem. Listy. 2013 107:522–529. Available online: http://chemicke-listy.cz/ojs3/index.php/chemicke-listy/article/view/6455.

Kaito S., Toya T., Yoshifuji K., Kurosawa S., Inamoto K., Takeshita K., Suda W., Kakihana K., Honda K., Hattori M., et al. Fecal Microbiota Transplantation with Frozen Capsules for a Patient with Refractory Acute Gut Graft-versus-Host Disease. Blood Adv. 2018;2:3097–3101. doi: 10.1182/bloodadvances.2018024968. PubMed DOI PMC

Ramai D., Zakhia K., Fields P.J., Ofosu A., Patel G., Shahnazarian V., Lai J.K., Dhaliwal A., Reddy M., Chang S. Fecal Microbiota Transplantation (FMT) with Colonoscopy Is Superior to Enema and Nasogastric Tube While Comparable to Capsule for the Treatment of Recurrent Clostridioides Difficile Infection: A Systematic Review and Meta-Analysis. Dig. Dis. Sci. 2021;66:369–380. doi: 10.1007/s10620-020-06185-7. PubMed DOI

Zheng L., Ji Y.-Y., Wen X.-L., Duan S.-L. Fecal Microbiota Transplantation in the Metabolic Diseases: Current Status and Perspectives. World J. Gastroenterol. 2022;28:2546–2560. doi: 10.3748/wjg.v28.i23.2546. PubMed DOI PMC

Huyghebaert N., Vermeire A., Remon J.P. Alternative Method for Enteric Coating of HPMC Capsules Resulting in Ready-to-Use Enteric-Coated Capsules. Eur. J. Pharm. Sci. 2004;21:617–623. doi: 10.1016/j.ejps.2004.01.002. PubMed DOI

Fülöpová N., Pavloková S., DeBono I., Vetchý D., Franc A. Development and Comparison of Various Coated Hard Capsules Suitable for Enteric Administration to Small Patient Cohorts. Pharmaceutics. 2022;14:1577. doi: 10.3390/pharmaceutics14081577. PubMed DOI PMC

Barbosa J.A.C., Al-Kauraishi M.M., Smith A.M., Conway B.R., Merchant H.A. Achieving Gastroresistance without Coating: Formulation of Capsule Shells from Enteric Polymers. Eur. J. Pharm. Biopharm. 2019;144:174–179. doi: 10.1016/j.ejpb.2019.09.015. PubMed DOI

Benameur H. Enteric Capsule Drug Delivery Technology–Achieving Protection without Coating. [(accessed on 15 September 2022)];Drug Dev. Deliv. 2015 15:34–37. Available online: https://drug-dev.com/capsule-technology-enteric-capsule-drug-delivery-technology-achieving-protection-without-coating/

Ph. Eur. MMXVII . European Pharmacopoeia. 9th ed. European Pharmacopoeia Commission; Strasbourg, France: 2017.

Dvořáčková K., Rabišková M., Muselík J., Gajdziok J., Bajerová M. Coated Hard Capsules as the PH-Dependent Drug Transport Systems to Ileo-Colonic Compartment. Drug Dev. Ind. Pharm. 2011;37:1131–1140. doi: 10.3109/03639045.2011.561350. PubMed DOI

Vraníková B., Franc A., Gajdziok J., Vetchý D. Biorelevant dissolution media simulating digestive tract conditions. [(accessed on 12 October 2022)];Chem. Listy. 2016 110:126–132. Available online: http://www.chemicke-listy.cz/ojs3/index.php/chemicke-listy/article/view/233/233.

Donauer N., Lobenberg R. A Mini Review of Scientific and Pharmacopeial Requirements for the Disintegration Test. Int. J. Pharm. 2007;345:2–8. doi: 10.1016/j.ijpharm.2007.08.045. PubMed DOI

United States Pharmacopeia. 43rd ed. United States Pharmacopeia Convention Committee of Revision; Rockville, MD, USA: 2021.

The Japanese Pharmacopeia. 17th ed. Society of Japanese Pharmacopoeia; Tokyo, Japan: 2016.

Katona M.T., Kakuk M., Szabó R., Tonka-Nagy P., Takács-Novák K., Borbás E. Towards a Better Understanding of the Post-Gastric Behavior of Enteric-Coated Formulations. Pharm. Res. 2022;39:201–211. doi: 10.1007/s11095-021-03163-0. PubMed DOI PMC

Al-Gousous J., Langguth P. European versus United States Pharmacopeia Disintegration Testing Methods for Enteric-Coated Soft Gelatin Capsules. Dissolution Technol. 2015;22:6–8. doi: 10.14227/DT220315P6. DOI

Mašková E., Kubová K., Vetchý D. Use of (Meth) Acrylate Copolymers in Controlled Release Matrix Tablet Technology. [(accessed on 15 October 2022)];Chem. Listy. 2015 109:14–20. Available online: http://www.chemicke-listy.cz/ojs3/index.php/chemicke-listy/article/view/408.

Maderuelo C., Lanao J.M., Zarzuelo A. Enteric Coating of Oral Solid Dosage Forms as a Tool to Improve Drug Bioavailability. Eur. J. Pharm. Sci. 2019;138:105019. doi: 10.1016/j.ejps.2019.105019. PubMed DOI

Al-Tabakha M.M., Arida A.I., Fahelelbom K.M.S., Sadek B., Abu Jarad R.A. Performances of New Generation of Delayed Release Capsules. J. Young Pharm. 2014;7:36–44. doi: 10.5530/jyp.2015.1.7. DOI

Liu F., McConnell E., Pygall S. Update on Polymers for Oral Drug Delivery. 1st ed. Smithers Rapra Technology; Shawburry, UK: 2011.

Edgar K.J. Cellulose Esters in Drug Delivery. Cellulose. 2006;14:49–64. doi: 10.1007/s10570-006-9087-7. DOI

Barbosa J. Going Natural: Using Polymers from Nature for Gastroresistant Applications. Br. J. Pharm. 2017;2:14–30. doi: 10.5920/bjpharm.2017.01. DOI

Sinha V.R., Kumria R. Polysaccharides in Colon-Specific Drug Delivery. Int. J. Pharm. 2001;224:19–38. doi: 10.1016/S0378-5173(01)00720-7. PubMed DOI

Layek B., Mandal S. Natural Polysaccharides for Controlled Delivery of Oral Therapeutics: A Recent Update. Carbohydr. Polym. 2020;230:115617. doi: 10.1016/j.carbpol.2019.115617. PubMed DOI

Rodríguez M.T.S., Urbano H.C., Muñoz de los Ríos D., Lara-Villoslada F., Martínez M.A.R., Hernández M.E.M. Evaluation of Viability of Lactobacillus fermentum CECT 5716 in Gelatin and Gastroresistant Capsules. J. Pharm. Pharmacol. 2016;4:413–418. doi: 10.17265/2328-2150/2016.08.009. DOI

Saringat H.B., Alfadol K.I., Khan G.M. The Influence of Different Plasticizers on Some Physical and Mechanical Properties of Hydroxypropyl Methylcellulose Free Films. Pak. J. Pharm. Sci. 2005;18:25–38. PubMed

De Oliveira H.P., Albuquerque J.J.F., Nogueiras C., Rieumont J. Physical Chemistry Behavior of Enteric Polymer in Drug Release Systems. Int. J. Pharm. 2009;366:185–189. doi: 10.1016/j.ijpharm.2008.08.041. PubMed DOI

Dudhat K.R. The Overview of Oral Solid Dosage Forms and Different Excipients Used for Solid Dosage Formulation. Glob. Acad. J. Pharm. Drug Res. 2022;4:66–72. doi: 10.36348/gajpdr.2022.v04i03.003. DOI

Coviello T., Matricardi P., Marianecci C., Alhaique F. Polysaccharide Hydrogels for Modified Release Formulations. J. Control. Release. 2007;119:5–24. doi: 10.1016/j.jconrel.2007.01.004. PubMed DOI

Podczeck F., Jones Brian E. In: Pharmaceutical Capsules. Jones B.E., Podczeck F., editors. Pharmaceutical Press; London, UK: 2004.

Murachanian D. Two-piece hard capsules for pharmaceutical formulation. J. GXP Compliance. 2010;14:31–42.

Zhang L., Wang Y., Liu H., Yu L., Liu X., Chen L., Zhang N. Developing Hydroxypropyl Methylcellulose/Hydroxypropyl Starch Blends for Use as Capsule Materials. Carbohydr. Polym. 2013;98:73–79. doi: 10.1016/j.carbpol.2013.05.070. PubMed DOI

Al-Tabakha M.M. HPMC Capsules: Current Status and Future Prospects. [(accessed on 20 August 2022)];J. Pharm. Pharmaceut. Sci. 2010 13:428–442. doi: 10.18433/J3K881. Available online: https://journals.library.ualberta.ca/jpps/index.php/JPPS/article/view/8870/7398. PubMed DOI

Hard Gelatin Capsules: Formulation and Manufacturing Considerations. [(accessed on 19 September 2022)]. Available online: https://www.pharmappsroach.com/hard-gelatin-capsules-formulation-and-manufacturing-considerations.

Podczeck F. The Development of an Instrumented Tamp-Filling Capsule Machine I. Eur. J. Pharm. Sci. 2000;10:267–274. doi: 10.1016/S0928-0987(00)00071-3. PubMed DOI

Kruisz J., Faulhammer E., Rehrl J., Scheibelhofer O., Witschnigg A., Khinast J.G. Residence Time Distribution of a Continuously-Operated Capsule Filling Machine: Development of a Measurement Technique and Comparison of Three Volume-Reducing Inserts. Int. J. Pharm. 2018;550:180–189. doi: 10.1016/j.ijpharm.2018.08.017. PubMed DOI

Deodhar C.P. Soft and Empty Hard Gelatine Capsule Technology. Nirali Prakashan; Bombai, India: 2019.

Capsule Sizes. [(accessed on 20 September 2022)]. Available online: https://www.saintytec.com/softgel-sizes.

Sizes_HPMC Capsule. [(accessed on 20 September 2022)]. Available online: https://www.saintytec.com/hpmc-capsule.

Capsule Sizes. [(accessed on 20 September 2022)]. Available online: https://www.medisca.com/Files/ReferenceCharts/Capsule%20Size%20Reference%20Chart%20-%20MUS%20&%20MCA.pdf.

Cohen W.M., Goto A., Nagata A., Nelson R.R., Walsh J.P. R&D Spillovers, Patents and the Incentives to Innovate in Japan and the United States. Res. Policy. 2002;31:1349–1367.

Varga A., Kocsis B., Sipos D., Kása P., Vigvári S., Pál S., Dembrovszky F., Farkas K., Péterfi Z. How to Apply FMT More Effectively, Conveniently and Flexible–A Comparison of FMT Methods. Front. Cell. Infect. Microbiol. 2021;11:657320. doi: 10.3389/fcimb.2021.657320. PubMed DOI PMC

AR CAPS® Enteric Capsules. [(accessed on 15 July 2022)]. Available online: https://www.cphi-online.com/ar-caps-enteric-capsules-prod476709.html.

Gastric acid Resistant Capsules_ARCAPS® CapsCanada. [(accessed on 15 July 2022)]. Available online: https://capscanada.com/products/acid-resistant-capsules.

Technical Data Sheet AR Caps Acid Resistant Capsules. [(accessed on 15 July 2022)]. Available online: https://www.gocaps.com/wp-content/uploads/2021/04/AR-Caps-Technical-Data-SheetPR00373576.pdf.

Marcial G.E., Ford A.L., Haller M.J., Gezan S.A., Harrison N.A., Cai D., Meyer J.L., Perry D.J., Atkinson M.A., Wasserfall C.H., et al. Lactobacillus Johnsonii N6.2 Modulates the Host Immune Responses: A Double-Blind, Randomized Trial in Healthy Adults. Front. Immunol. 2017;8:655. doi: 10.3389/fimmu.2017.00655. PubMed DOI PMC

Capsugel_EnTRinsic Drug Delivery Technology Platform. [(accessed on 6 June 2022)]. Available online: https://www.capsugel.com/news/capsugel-launches-breakthrough-entrinsic-drug-delivery-technology-platform.

EnTRinsic Drug Delivery Technology. [(accessed on 10 June 2022)]. Available online: https://pharma.lonza.co.jp/-/media/Lonza/knowledge/Small-Molecules/Tech%20Briefs/Lonza_tech-brief_Targeted-enTRinsic_ODP.pdf.

Rowe R.C., Sheskey P.J., Weller P.J. Handbook of Pharmaceutical Excipients. The Pharmaceutical Press; London, UK: 2003.

Capsugel New Intrinsically Enteric Capsule Technology for Pharmaceutical Drug Development. 2017. [(accessed on 9 September 2022)]. Available online: https://www.youtube.com/watch?v=yKAb_oKMuTY.

Lee H.W., Kang W.Y., Jung W., Gwon M.-R., Cho K., Yoon Y.-R., Seong S.J. Pharmacokinetics and Pharmacodynamics of YYD601, a Dual Delayed-Release Formulation of Esomeprazole, Following Single and Multiple Doses in Healthy Adult Volunteers Under Fasting and Fed Conditions. Drug Des. Devel. Ther. 2022;16:619–634. doi: 10.2147/DDDT.S338131. PubMed DOI PMC

Sager M., Grimm M., Aude P., Schick P., Merdivan S., Hasan M., Kromrey M.-L., Sivert A., Benameur H., Koziolek M., et al. In Vivo Characterization of EnTRinsicTM Drug Delivery Technology Capsule after Intake in Fed State: A Cross-Validation Approach Using Salivary Tracer Technique in Comparison to MRI. J. Control. Release. 2019;313:24–32. doi: 10.1016/j.jconrel.2019.10.023. PubMed DOI

Benameur H. EnTRinsic™ Drug Delivery Technology for Live Biotherapeutics (Microbiomes). Recent Achievements and Further Challenges in Drug Delivery Research; Proceedings of the 12th France-Japan Drug Delivery Systems Symposium; Abbaye des Vaux de Cernay, France. 9–12 October 2016; [(accessed on 15 September 2022)]. Available online: https://www.umr-cnrs8612.universite-paris-saclay.fr/docs/pdf/Prog-Symposium-Japon-2016.pdf#page=19.

Jančálková M. Master’s Thesis. Masaryk University; Brno, Czech Republic: 2021. Capsule Coating for Faecal Transplant Transport.

Vcaps® Enteric Capsules_Capsugel®. [(accessed on 19 September 2022)]. Available online: https://www.capsugel.com/biopharmaceutical-products/vcaps-enteric-capsules.

Capsugel_Vcaps® Enteric. [(accessed on 10 September 2022)]. Available online: http://alfresco-static-files.s3.amazonaws.com/alfresco_images/pharma/2018/10/11/0592de88-9026-4c61-b660-f5fd790b7cea/PharmTech_Europe_July2018.pdf#page=38.

Monschke M., Kayser K., Wagner K.G. Influence of Particle Size and Drug Load on Amorphous Solid Dispersions Containing PH-Dependent Soluble Polymers and the Weak Base Ketoconazole. AAPS PharmSciTech. 2021;22:44. doi: 10.1208/s12249-020-01914-7. PubMed DOI PMC

Li T., Wan B., Jog R., Costa A., Burgess D.J. Pectin Microparticles for Peptide Delivery: Optimization of Spray Drying Processing. Int. J. Pharm. 2022;613:121384. doi: 10.1016/j.ijpharm.2021.121384. PubMed DOI

Vcaps Enteric. [(accessed on 10 September 2022)]. Available online: https://cpsl-web.s3.amazonaws.com/kc/Vcaps-Enteric_Oct-2017.pdf?mtime=20171017051951.

Barbosa J.A.C., Abdelsadig M.S.E., Conway B.R., Merchant H.A. Using Zeta Potential to Study the Ionisation Behaviour of Polymers Employed in Modified-Release Dosage Forms and Estimating Their PKa. Int. J. Pharm. X. 2019;1:100024. doi: 10.1016/j.ijpx.2019.100024. PubMed DOI PMC

Capsugel. Lonza Company; Colmar, France: 2020. Certificate of analysis: Empty DRcapsTM capsules.

DRcaps_Capsules. [(accessed on 10 September 2022)]. Available online: https://s3.amazonaws.com/cpsl-web/kc/library/c1a-32029_DRCaps-A4_FIN.PDF.

Tuleu C., Khela M.K., Evans D.F., Jones B.E., Nagata S., Basit A.W. A Scintigraphic Investigation of the Disintegration Behaviour of Capsules in Fasting Subjects: A Comparison of Hypromellose Capsules Containing Carrageenan as a Gelling Agent and Standard Gelatin Capsules. Eur. J. Pharm. Sci. 2007;30:251–255. doi: 10.1016/j.ejps.2006.11.008. PubMed DOI

Amo R. DRcaps Capsules Achieve Delayed Release Properties for Nutritional Ingredients in Human Clinical Study. Capsugel. 2021. [(accessed on 10 September 2022)]. Available online: https://www.pharmaexcipients.com/wp-content/uploads/2021/01/DRcaps%C2%AE-Capsules-Achieve-Delayed-Release-Properties-for-Nutritional-Ingredients-in-Human-Clinical-Study.pdf.

Grimm M., Ball K., Scholz E., Schneider F., Sivert A., Benameur H., Kromrey M.L., Kühn J.P., Weitschies W. Characterization of the Gastrointestinal Transit and Disintegration Behavior of Floating and Sinking Acid-Resistant Capsules Using a Novel MRI Labeling Technique. Eur. J. Pharm. Sci. 2019;129:163–172. doi: 10.1016/j.ejps.2019.01.012. PubMed DOI

Youngster I., Russell G.H., Pindar C., Ziv-Baran T., Sauk J., Hohmann E.L. Oral, Capsulized, Frozen Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection. JAMA. 2014;312:1772–1778. doi: 10.1001/jama.2014.13875. PubMed DOI

Marzorati M., Possemiers S., Verhelst A., Cadé D., Madit N., Van de Wiele T. A Novel Hypromellose Capsule, with Acid Resistance Properties, Permits the Targeted Delivery of Acid-Sensitive Products to the Intestine. LWT-Food Sci. Technol. 2015;60:544–551. doi: 10.1016/j.lwt.2014.08.040. DOI

Rump A., Weiss F.N., Schulz L., Kromrey M.L., Scheuch E., Tzvetkov M.V., White T., Durkee S., Judge K.W., Jannin V., et al. The Effect of Capsule-in-Capsule Combinations on in Vivo Disintegration in Human Volunteers: A Combined Imaging and Salivary Tracer Study. Pharmaceutics. 2021;13:2002. doi: 10.3390/pharmaceutics13122002. PubMed DOI PMC

Empty Capsules. [(accessed on 14 August 2022)]. Available online: https://www.purecapsules.co.uk/index.php/product/index/mid/76.

Embocaps®. [(accessed on 12 August 2022)]. Available online: https://www.embocaps.com/sub/capsule-advantage-design.php.

EMBO CAPS AP_Brochure. [(accessed on 15 August 2022)]. Available online: https://www.embocaps.com/sub/brochure/products-ap.pdf.

Probiotics Swanson®. [(accessed on 13 August 2022)]. Available online: https://www.swansonvitamins.com/ncat1/Health+Concerns/ncat2/Digestive+System/ncat3/Probiotics/q.

Embo caps®_Suheung Capsule Co. [(accessed on 19 July 2022)]. Available online: https://www.cphi-online.com/embo-caps-prod047905.html.

Chang R.J., Wu C.J., Lin Y.H. Acid Resistant Capsule Shell Composition, Acid Resistant Capsule Shell and Its Preparing Process. No. 9,452,141 B1. U.S. Patent. 2016 September 27;

BioVXR Acid Resistant Capsules. [(accessed on 16 August 2022)]. Available online: https://www.dfc.com.tw/archive/product/item/files/BioVXR%20brochure%202022.pdf.

Acid Resistant Vegetable Capsules Bio-VXR. [(accessed on 19 August 2022)]. Available online: https://biocaps.net/portfolio/acid-resistant-vegetable-capsules.

Sangve A.V., Bansode S.S., Menon M.D. Evaluation of Side selective release of Probiotics from an HPMC Delayed release capsule. Disso India-Chandigarh; Proceedings of the 7th International Annual Symposium; Chandigarh, India. 12–13 September 2019; [(accessed on 5 October 2022)]. Available online: https://spds.in/wp-content/uploads/2020/07/Disso-India-Chandhigarh-scientifica-abstract-book-2019-dt-30-8-19.pdf.

ACG_Formulation: Flexibility with New Era HPMC Capsules. [(accessed on 10 September 2022)]. Available online: https://ondrugdelivery.com/wp-content/uploads/2020/07/109_Jul_2020_ACG.pdf.

ACG Capsule Brochure. [(accessed on 10 September 2022)]. Available online: https://issuu.com/acggroup/docs/capsule_20range_20brochure-web_20us.

ACGcapsTM_ ACG. [(accessed on 12 September 2022)]. Available online: https://www.acg-world.com/archives/capsules/hpmc-capsules/acgcapstm-hr.

ACGCAPS_HD_Capsules. [(accessed on 12 September 2022)]. Available online: https://www.justdial.com/jdmart/Mumbai/ACGCAPS-HD-Capsules/pid-2020831557/022P427056.

Cold F., Baunwall S.M.D., Dahlerup J.F., Petersen A.M., Hvas C.L., Hansen L.H. Systematic Review with Meta-Analysis: Encapsulated Faecal Microbiota Transplantation–Evidence for Clinical Efficacy. Therap. Adv. Gastroenterol. 2021;14:175628482110410. doi: 10.1177/17562848211041004. PubMed DOI PMC

Walker E.G., Lo K.R., Pahl M.C., Shin H.S., Lang C., Wohlers M.W., Poppitt S.D., Sutton K.H., Ingram J.R. An Extract of Hops (Humulus Lupulus L.) Modulates Gut Peptide Hormone Secretion and Reduces Energy Intake in Healthy-Weight Men: A Randomized, Crossover Clinical Trial. Am. J. Clin. Nutr. 2022;115:925–940. doi: 10.1093/ajcn/nqab418. PubMed DOI

Reid I.R., Wen J., Mellar A., Liu M., Jabr A., Horne A.M. Effect of Oral Zoledronate Administration on Bone Turnover in Older Women. Br. J. Clin. Pharmacol. 2022:1–6. doi: 10.1111/bcp.15559. PubMed DOI

Zain N.M.M., Ter Linden D., Lilley A.K., Royall P.G., Tsoka S., Bruce K.D., Mason A.J., Hatton G.B., Allen E., Goldenberg S.D., et al. Design and Manufacture of a Lyophilised Faecal Microbiota Capsule Formulation to GMP Standards. J. Control. Release. 2022;350:324–331. doi: 10.1016/j.jconrel.2022.08.012. PubMed DOI

Reigadas E., Bouza E., Olmedo M., Vázquez-Cuesta S., Villar-Gómara L., Alcalá L., Marín M., Rodríguez-Fernández S., Valerio M., Muñoz P. Faecal Microbiota Transplantation for Recurrent Clostridioides Difficile Infection: Experience with Lyophilized Oral Capsules. J. Hosp. Infect. 2020;105:319–324. doi: 10.1016/j.jhin.2019.12.022. PubMed DOI

Leong K.S.W., Jayasinghe T.N., Derraik J.G.B., Albert B.B., Chiavaroli V., Svirskis D.M., Beck K.L., Conlon C.A., Jiang Y., Schierding W., et al. Protocol for the Gut Bugs Trial: A Randomised Double-Blind Placebo-Controlled Trial of Gut Microbiome Transfer for the Treatment of Obesity in Adolescents. BMJ Open. 2019;9:e026174. doi: 10.1136/bmjopen-2018-026174. PubMed DOI PMC

Jiang Z.-D., Jenq R.R., Ajami N.J., Petrosino J.F., Alexander A.A., Ke S., Iqbal T., DuPont A.W., Muldrew K., Shi Y., et al. Safety and Preliminary Efficacy of Orally Administered Lyophilized Fecal Microbiota Product Compared with Frozen Product given by Enema for Recurrent Clostridium Difficile Infection: A Randomized Clinical Trial. PLoS ONE. 2018;13:e0205064. doi: 10.1371/journal.pone.0205064. PubMed DOI PMC

Chehri M., Christensen A.H., Halkjær S.I., Günther S., Petersen A.M., Helms M. Case Series of Successful Treatment with Fecal Microbiota Transplant (FMT) Oral Capsules Mixed from Multiple Donors Even in Patients Previously Treated with FMT Enemas for Recurrent Clostridium Difficile Infection. Medicine. 2018;97:e11706. doi: 10.1097/MD.0000000000011706. PubMed DOI PMC

Halkjær S.I., Christensen A.H., Lo B.Z.S., Browne P.D., Günther S., Hansen L.H., Petersen A.M. Faecal Microbiota Transplantation Alters Gut Microbiota in Patients with Irritable Bowel Syndrome: Results from a Randomised, Double-Blind Placebo-Controlled Study. Gut. 2018;67:2107–2115. doi: 10.1136/gutjnl-2018-316434. PubMed DOI

Staley C., Hamilton M.J., Vaughn B.P., Graiziger C.T., Newman K.M., Kabage A.J., Sadowsky M.J., Khoruts A. Successful Resolution of Recurrent Clostridium Difficile Infection Using Freeze-Dried, Encapsulated Fecal Microbiota; Pragmatic Cohort Study. Am. J. Gastroenterol. Suppl. 2017;112:940–947. doi: 10.1038/ajg.2017.6. PubMed DOI PMC

Khanna S., Pardi D.S., Kelly C.R., Kraft C.S., Dhere T., Henn M.R., Lombardo M.-J., Vulic M., Ohsumi T., Winkler J., et al. A Novel Microbiome Therapeutic Increases Gut Microbial Diversity and Prevents Recurrent Clostridium Difficile Infection. J. Infect. Dis. 2016;214:173–181. doi: 10.1093/infdis/jiv766. PubMed DOI

Hirsch B.E., Saraiya N., Poeth K., Schwartz R.M., Epstein M.E., Honig G. Effectiveness of Fecal-Derived Microbiota Transfer Using Orally Administered Capsules for Recurrent Clostridium Difficile Infection. BMC Infect. Dis. 2015;15:191. doi: 10.1186/s12879-015-0930-z. PubMed DOI PMC

Jones M.L., Martoni C.J., Prakash S. Cholesterol Lowering and Inhibition of Sterol Absorption by Lactobacillus Reuteri NCIMB 30242: A Randomized Controlled Trial. Eur. J. Clin. Nutr. 2012;66:1234–1241. doi: 10.1038/ejcn.2012.126. PubMed DOI

Jones M.L., Martoni C.J., di Pietro E., Simon R.R., Prakash S. Evaluation of Clinical Safety and Tolerance of a Lactobacillus Reuteri NCIMB 30242 Supplement Capsule: A Randomized Control Trial. Regul. Toxicol. Pharmacol. 2012;63:313–320. doi: 10.1016/j.yrtph.2012.04.003. PubMed DOI

Sonaje K., Chen Y.-J., Chen H.-L., Wey S.-P., Juang J.-H., Nguyen H.-N., Hsu C.-W., Lin K.-J., Sung H.-W. Enteric-Coated Capsules Filled with Freeze-Dried Chitosan/Poly(γ-Glutamic Acid) Nanoparticles for Oral Insulin Delivery. Biomaterials. 2010;31:3384–3394. doi: 10.1016/j.biomaterials.2010.01.042. PubMed DOI

Saphier S., Rosner A., Brandeis R., Karton Y. Gastro Intestinal Tracking and Gastric Emptying of Solid Dosage Forms in Rats Using X-ray Imagining. Int. J. Pharm. 2010;388:190–195. doi: 10.1016/j.ijpharm.2010.01.001. PubMed DOI

Gómez-Lado N., Seoane-Viaño I., Matiz S., Madla C.M., Yadav V., Aguiar P., Basit A.W., Goyanes A. Gastrointestinal Tracking and Gastric Emptying of Coated Capsules in Rats with or without Sedation Using CT Imaging. Pharmaceutics. 2020;12:81. doi: 10.3390/pharmaceutics12010081. PubMed DOI PMC

Preparation and Evaluation of a Dosage Form for Individualized Administration of Lyophilized Probiotics