PROTEIN AND PEPTIDE BASED DRUG DELIVERY: PHARMACEUTICAL APPROACHES
Abstract
Protein and peptide are last three decades therapeutic peptides and proteins have risen in prominence as potential drug of future. Polymers of protein consist of amino acids covalently linked by peptide bonds. Peptides are small proteins composed of up to a couple of dozen amino acids proteins are rapidly degraded by digestive enzymes. Till recently, injections remain the foremost common means for administering these protein and peptide drugs. In the other routes that have been tried with varying degrees of success are the oral, buccal, intranasal, pulmonary, transdermal, ocular and rectal. In this review, the aim is to specialise in the varied routes and approaches for delivery of Peptide and protein drugs. The Continuous efforts are focussed for formulation of this therapeutics into safe and effective delivery systems. In this review briefly describes the possible methods for the delivery of protein and peptide drugs through various routes.
Keywords:
Proteins, Peptides, pproaches, oral delivery, formulation vehicles, absorption enhancers
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References
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Patel A, Cholkar K, Mitra AK. Recent Developments in Protein and Peptide Parenteral Delivery Approaches. There Delivery. 2014;5(3):337–652
V Rajesh Babu, Syeda Rana Nikhat, P Nivethithai, SH Areefulla; Approaches and Challenges of Protein and Peptide Drug Delivery Systems; Research Journal of Pharmacy and Technology,0974-360X, Pages: 379-384, Vol No: 3, 2010.
Gary Gellerman, Yosi Gilad, Review Recent Innovations in Peptide Based Targeted Drug Delivery to Cancer Cells, Biomedicines, 4, 2016, 2-24.
Carol S Lim, Benjamin J Bruno, Basics and recent advances in peptide and protein drug delivery, Therapeutic Delivery,2013, 4, 1443–1467
Shaji J, Patole V. Protein and Peptide drug delivery: oral approaches, Indian J Pharm Sci, 70, 2008, 269-77.
Ram IMahato, Ajit S Narang. Emerging trends in oral delivery of peptide and protein drugs, Crit Rev Ther Drug Carrier Syst,2013, 2013, 153-214
Shaji J, Patole V. Protein and Peptide drug delivery: oral approaches, Indian J Pharm Sci, 70, 2008, 269-77.
Ram I, Mahato, Ajit S Narang. Emerging trends in oral delivery of peptide and protein drugs, Crit Rev Ther Drug Carrier Syst,2013, 2013, 153-214.
JessyShaji, Patole V, Protien and peptide delivery: oral approach, Indian journal of pharmaceutical Sciences,70, 2008, 269-277, Doi: 10.4172
ThiagoCaon, Liang Jin, Enhancing the Buccal Mucosal Delivery of Peptide and Protein Therapeutics, Pharm Res, 32, 2014, 1-21.
Sanjoy Das, Asish Bhaumik, Protein & peptide drug delivery: a fundamental novel approach and future perspective, World journal of pharmacy and pharmaceutical sciences, 5, 2014, 763-776.
Jitendra Sharma PK, Noninvasive Routes of Proteins and Peptides Drug Delivery, Indian Journal of Pharmaceutical Sciences, 73, 2014, 367-375.
Akhilesh K Jain, Sunil K Jain, Non-Invasive Systemic Delivery of Proteins(s) and Peptide(s), Pharmagene,1, 2013, 73-84.
Rahisuddin, Pramod k sharma, Garimagarg, Review on nasal drug delivery system with recent advancement, International Journal of Pharmacy and Pharmaceutical Sciences,3, 2011, 6-11.
Talegaonkar S, Mishra PR, Intranasal delivery: An approach to bypass the blood brain barrier, Indian J Pharmacology, 36, 2014, 140-147
Sarika Namjoshi, Proteins and Peptides: Strategies for Delivery to and Across the Skin, Journal of pharmaceutical sciences, 97, 2008, 3591–3610,
Patil JS, Sarasija S, Pulmonary drug delivery strategies: A concise, systematic review, Lung India, 29, 2012, 44-49.
Remigius Uchenna Agu, Michael Ikechukwu Ugwoke, Michoel Armand, The lung as a route for systemic delivery of therapeutic proteins and peptides, Respir Res, 2, 2001, 198–209
Shah ND, Shah VV, Chivate ND, Pulmonary Drug Delivery: A Promising Approach, Journal of Applied Pharmaceutical Science, 02, 2012, 33-37,
Pushkar Baviskara, Anjali Bedsea, Drug Delivery on Rectal Absorption: Suppositories, International Journal of Pharmaceutical Sciences Review and Research, 21, 2011, 70-76.
Lakshmi Prasanna J, Deepthi B, Rectal drug delivery: A promising route for enhancing drug absorption, Asian J. Res. Pharm. Sci, 2, 2012, 143-149.
Sagar Kishor Savale. Protein and peptide drug delivery system. World journal of pharmacy and pharmaceutical sciences.5: 2016, 724-742
Jain A, Gulbake A, Peptide and protein delivery using new drug delivery systems, Critical Reviews in Therapeutic Drug Carrier Systems, 2013, 30, 293-329.
Ram IM, Ajit SN, Laura T, Duane DM. Emerging trends in oral delivery of peptide and protein drugs. Crit Rev Ther Drug Carrier Syst. 2003; 20:153–214.
Hashimoto M, Takada K, Kiso Y, Muranishi S. Synthesis of palmitoyl derivatives of insulin and their biological activities. Pharm Res. 1989; 6:171–6.
Brader ML, Sukumar M, Pekar AH, McClellan DS, Chance RE, Flora DB, et al. Hybrid insulin cocrystals for controlled release delivery. Nat Biotechnol. 2002; 20:800–4.
Bernkop SA. The use of inhibitory agents to overcome the enzymatic barrier to perorally administered therapeutic peptides and proteins. J Control Release. 1998; 52:1–16.
Andreas BS, Alexander HK, Verena ML, Thomas P. Thiomers: potential excipients for non-invasive peptide delivery systems. Eur J Pharm Biopharm. 2004; 58:253–63.
Aungst B. Intestinal permeation enhancers. J Pharm Sci. 2000; 89:429–42.
Lecluyse EL, Sutton SC. In vitro models for selection of development candidates. Permeability studies to define mechanisms of absorption enhancement. Adv Drug Deliv Rev. 1997; 23:163–83.
Sood A, Panchagnula R. Peroral route: An opportunity for protein and peptide drug delivery. Chem Rev. 2001; 101:3275–303.
Hochman J, Artursson P. Mechanisms of absorption enhancement and tight junction regulation. J Control Release. 1994; 29:253–67.
Sakai M, Imai T, Ohtake H, Otagiri M. Cytotoxicity of absorption enhancers in Caco-2 cell monolayers. J Pharm Pharmacol. 1998; 50:1101–8.
Obata Y, Sesumi T, Takayama K. Evaluation of skin damage caused by percutaneous absorption enhancers using fractal analysis. J Pharm Sci. 2000; 89:556–61.
Fasano A, Uzzau S. Modulation of intestinal tight junctions by Zonula Occludens toxin permits enteral administration of insulin and other macromolecules in an animal model. J Clin Invest. 1997; 99:1158–64.
Karyekar CS, Fasano A, Raje S. Zonula Occludens toxin increases the permeability of molecular weight markers and chemotherapeutic agents across the bovine brain microvessel endothelial cells. J Pharm Sci. 2003; 92:414–23.
Leone-Bay A, Sato M, Paton D, Hunt AH, Sarubbi D, Carozza M. Oral delivery of biologically active parathyroid hormone. Pharm Res. 2001; 18:964–70.
Leone-Bay A, Ho KK, Agarwal R, Baughman RA, Chaudhary K, De Morin F. 4-[4-[(2-Hydroxybenzoyl) amino] phenyl] butyric acid as a novel oral delivery agent for recombinant human growth hormone. J Med Chem. 1996; 39:2571–8.
Milstein SJ, Leipold H, Sarubbi D, Leone-Bay A, Mlynek GM, Robinson JR. Partially unfolded proteins efficiently penetrate cell membranes: Implications for oral drug delivery. J Control Release. 1998; 53:259–67.
Wu SJ, Robinson JR. Transport of human growth hormone across Caco-2 cells with novel delivery agents: Evidence for P-glycoprotein involvement. J Control Release. 1999; 62:171–7.
Toorisaka E, Ono H, Arimori K, Kamiya N, Goto M. Hypoglycemic effect of surfactant-coated insulin solubilized in a novel solid-in-oil-in-water (S/O/W) emulsion. Int J Pharm. 2003; 252:271–4.
Dollo G, Corrre PL, Guerin A, Chevanne F, Burgot JL, Leverge R. Spray-dried re dispersible oil-in-water emulsion to improve oral bioavailability of poorly soluble drugs. Eur J Pharm Sci. 2003;19:273–80
Christensen KL, Pedersen GP, Kristensen HG. Physical stability of re dispersible dry emulsions containing amorphous sucrose. Eur J Pharm Biopharm. 2002;53:147–53.
Takeuchi H, Sasaki H, Niwa T, Hino T, Kawashima Y, Uesugi K, et al. Design of redispersible dry emulsion as an advanced dosage form of oily drug (vitamin E nicotinate) by spray-drying technique. Drug Develop Ind Pharm. 1992;18:919–37.
Molina C, Cadorniga R. Physical stability of lyophilized and sterilized emulsions. STP Pharma Pratiques. 1995;5:63–72
Myers SL, Shively ML. Preparation and characterization of emulsifiable glasses: Oil-in-water and water-in-oil-in-water emulsions. J Colloid Interface Sci. 1992; 149:71–8.
Sakuma S, Hayashi M, Akashi M. Design of nanoparticles composed of graft copolymers for oral peptide delivery. Adv Drug Deliv Rev. 2001;47:21–37.
Patel HM, Túzél NS, Stevenson RW. Intracellular digestion of saturated and unsaturated phospholipid liposomes by mucosal cells: Possible mechanism of transport of liposomally entrapped macromolecules across the isolated vascularly perfused rabbit ileum. Biochim Biophys Acta. 1985; 839:40–9.
Tomizowal H, Aramaki V, Fujii Y. Uptake of phosphotidylserine liposomes by rat Peyer’s patches following intraluminal administration. Pharm Res. 1993; 10:549–52.
Iwanaga K, Ono S, Narioka K, Morimoto K, Kakemi M, Yamashita S, et al. Oral delivery of insulin by using surface coating liposomes improvement of stability of insulin in GI tract. Int J Pharm. 1997; 157:73–80.
Eiamtrakarn S, Itoh Y, Kishimoto J, Yoshikawa Y, Shibata N, Murakami, Takada K. Gastrointestinal mucoadhesive patch system (GI-MAPS) for oral administration of G-CSF, a model protein. Biomaterials. 2002; 23:145–52.
Bai JP, Chang LL, Guo JH. Effects of polyacrylic polymers on the degradation of insulin and peptide drugs by chymotrypsin and trypsin. J Pharm Pharmacol. 1996; 48:17–21.
Gu JM, Robinson JR, Leung SH. Binding of acrylic polymers to mucin/epithelial surface: Structure-property relationships. Crit Rev Ther Drug Carrier Syst. 1988; 5:21–67.
Woodley J. Bioadhesion: New possibilities for drug administration? Clin Pharmacokinet. 2001; 40:77–84.
Leitner VM, Walker GF, Schnurch AB. Thiolated polymers: Evidence for the formation of disulphide bonds with mucus glycoproteins. Eur J Pharm Biopharm. 2003; 56:207–14
Hussain N, Jani PU, Florence AT. Enhanced oral uptake of tomato lectin-conjugated nanoparticles in the rat. Pharm Res. 1997; 14:613–8.
Haas J, Lehr CM. Developments in the area of bioadhesive drug delivery systems. Exp Opin Biol Ther. 2002; 2:287–98.
Bernkop SA, Krajicek ME. Mucoadhesive polymers as platforms for peroral peptide delivery and absorption: Synthesis and evaluation of different chitosan-EDTA conjugates. J Control Release. 1998; 50:215–23.
Patel A, Cholkar K, Mitra AK. Recent Developments in Protein and Peptide Parenteral Delivery Approaches. There Delivery. 2014;5(3):337–652
V Rajesh Babu, Syeda Rana Nikhat, P Nivethithai, SH Areefulla; Approaches and Challenges of Protein and Peptide Drug Delivery Systems; Research Journal of Pharmacy and Technology,0974-360X, Pages: 379-384, Vol No: 3, 2010.
Gary Gellerman, Yosi Gilad, Review Recent Innovations in Peptide Based Targeted Drug Delivery to Cancer Cells, Biomedicines, 4, 2016, 2-24.
Carol S Lim, Benjamin J Bruno, Basics and recent advances in peptide and protein drug delivery, Therapeutic Delivery,2013, 4, 1443–1467
Shaji J, Patole V. Protein and Peptide drug delivery: oral approaches, Indian J Pharm Sci, 70, 2008, 269-77.
Ram IMahato, Ajit S Narang. Emerging trends in oral delivery of peptide and protein drugs, Crit Rev Ther Drug Carrier Syst,2013, 2013, 153-214
Shaji J, Patole V. Protein and Peptide drug delivery: oral approaches, Indian J Pharm Sci, 70, 2008, 269-77.
Ram I, Mahato, Ajit S Narang. Emerging trends in oral delivery of peptide and protein drugs, Crit Rev Ther Drug Carrier Syst,2013, 2013, 153-214.
JessyShaji, Patole V, Protien and peptide delivery: oral approach, Indian journal of pharmaceutical Sciences,70, 2008, 269-277, Doi: 10.4172
ThiagoCaon, Liang Jin, Enhancing the Buccal Mucosal Delivery of Peptide and Protein Therapeutics, Pharm Res, 32, 2014, 1-21.
Sanjoy Das, Asish Bhaumik, Protein & peptide drug delivery: a fundamental novel approach and future perspective, World journal of pharmacy and pharmaceutical sciences, 5, 2014, 763-776.
Jitendra Sharma PK, Noninvasive Routes of Proteins and Peptides Drug Delivery, Indian Journal of Pharmaceutical Sciences, 73, 2014, 367-375.
Akhilesh K Jain, Sunil K Jain, Non-Invasive Systemic Delivery of Proteins(s) and Peptide(s), Pharmagene,1, 2013, 73-84.
Rahisuddin, Pramod k sharma, Garimagarg, Review on nasal drug delivery system with recent advancement, International Journal of Pharmacy and Pharmaceutical Sciences,3, 2011, 6-11.
Talegaonkar S, Mishra PR, Intranasal delivery: An approach to bypass the blood brain barrier, Indian J Pharmacology, 36, 2014, 140-147
Sarika Namjoshi, Proteins and Peptides: Strategies for Delivery to and Across the Skin, Journal of pharmaceutical sciences, 97, 2008, 3591–3610,
Patil JS, Sarasija S, Pulmonary drug delivery strategies: A concise, systematic review, Lung India, 29, 2012, 44-49.
Remigius Uchenna Agu, Michael Ikechukwu Ugwoke, Michoel Armand, The lung as a route for systemic delivery of therapeutic proteins and peptides, Respir Res, 2, 2001, 198–209
Shah ND, Shah VV, Chivate ND, Pulmonary Drug Delivery: A Promising Approach, Journal of Applied Pharmaceutical Science, 02, 2012, 33-37,
Pushkar Baviskara, Anjali Bedsea, Drug Delivery on Rectal Absorption: Suppositories, International Journal of Pharmaceutical Sciences Review and Research, 21, 2011, 70-76.
Lakshmi Prasanna J, Deepthi B, Rectal drug delivery: A promising route for enhancing drug absorption, Asian J. Res. Pharm. Sci, 2, 2012, 143-149.
Sagar Kishor Savale. Protein and peptide drug delivery system. World journal of pharmacy and pharmaceutical sciences.5: 2016, 724-742
Jain A, Gulbake A, Peptide and protein delivery using new drug delivery systems, Critical Reviews in Therapeutic Drug Carrier Systems, 2013, 30, 293-329.
Ram IM, Ajit SN, Laura T, Duane DM. Emerging trends in oral delivery of peptide and protein drugs. Crit Rev Ther Drug Carrier Syst. 2003; 20:153–214.
Hashimoto M, Takada K, Kiso Y, Muranishi S. Synthesis of palmitoyl derivatives of insulin and their biological activities. Pharm Res. 1989; 6:171–6.
Brader ML, Sukumar M, Pekar AH, McClellan DS, Chance RE, Flora DB, et al. Hybrid insulin cocrystals for controlled release delivery. Nat Biotechnol. 2002; 20:800–4.
Bernkop SA. The use of inhibitory agents to overcome the enzymatic barrier to perorally administered therapeutic peptides and proteins. J Control Release. 1998; 52:1–16.
Andreas BS, Alexander HK, Verena ML, Thomas P. Thiomers: potential excipients for non-invasive peptide delivery systems. Eur J Pharm Biopharm. 2004; 58:253–63.
Aungst B. Intestinal permeation enhancers. J Pharm Sci. 2000; 89:429–42.
Lecluyse EL, Sutton SC. In vitro models for selection of development candidates. Permeability studies to define mechanisms of absorption enhancement. Adv Drug Deliv Rev. 1997; 23:163–83.
Sood A, Panchagnula R. Peroral route: An opportunity for protein and peptide drug delivery. Chem Rev. 2001; 101:3275–303.
Hochman J, Artursson P. Mechanisms of absorption enhancement and tight junction regulation. J Control Release. 1994; 29:253–67.
Sakai M, Imai T, Ohtake H, Otagiri M. Cytotoxicity of absorption enhancers in Caco-2 cell monolayers. J Pharm Pharmacol. 1998; 50:1101–8.
Obata Y, Sesumi T, Takayama K. Evaluation of skin damage caused by percutaneous absorption enhancers using fractal analysis. J Pharm Sci. 2000; 89:556–61.
Fasano A, Uzzau S. Modulation of intestinal tight junctions by Zonula Occludens toxin permits enteral administration of insulin and other macromolecules in an animal model. J Clin Invest. 1997; 99:1158–64.
Karyekar CS, Fasano A, Raje S. Zonula Occludens toxin increases the permeability of molecular weight markers and chemotherapeutic agents across the bovine brain microvessel endothelial cells. J Pharm Sci. 2003; 92:414–23.
Leone-Bay A, Sato M, Paton D, Hunt AH, Sarubbi D, Carozza M. Oral delivery of biologically active parathyroid hormone. Pharm Res. 2001; 18:964–70.
Leone-Bay A, Ho KK, Agarwal R, Baughman RA, Chaudhary K, De Morin F. 4-[4-[(2-Hydroxybenzoyl) amino] phenyl] butyric acid as a novel oral delivery agent for recombinant human growth hormone. J Med Chem. 1996; 39:2571–8.
Milstein SJ, Leipold H, Sarubbi D, Leone-Bay A, Mlynek GM, Robinson JR. Partially unfolded proteins efficiently penetrate cell membranes: Implications for oral drug delivery. J Control Release. 1998; 53:259–67.
Wu SJ, Robinson JR. Transport of human growth hormone across Caco-2 cells with novel delivery agents: Evidence for P-glycoprotein involvement. J Control Release. 1999; 62:171–7.
Toorisaka E, Ono H, Arimori K, Kamiya N, Goto M. Hypoglycemic effect of surfactant-coated insulin solubilized in a novel solid-in-oil-in-water (S/O/W) emulsion. Int J Pharm. 2003; 252:271–4.
Dollo G, Corrre PL, Guerin A, Chevanne F, Burgot JL, Leverge R. Spray-dried re dispersible oil-in-water emulsion to improve oral bioavailability of poorly soluble drugs. Eur J Pharm Sci. 2003;19:273–80
Christensen KL, Pedersen GP, Kristensen HG. Physical stability of re dispersible dry emulsions containing amorphous sucrose. Eur J Pharm Biopharm. 2002;53:147–53.
Takeuchi H, Sasaki H, Niwa T, Hino T, Kawashima Y, Uesugi K, et al. Design of redispersible dry emulsion as an advanced dosage form of oily drug (vitamin E nicotinate) by spray-drying technique. Drug Develop Ind Pharm. 1992;18:919–37.
Molina C, Cadorniga R. Physical stability of lyophilized and sterilized emulsions. STP Pharma Pratiques. 1995;5:63–72
Myers SL, Shively ML. Preparation and characterization of emulsifiable glasses: Oil-in-water and water-in-oil-in-water emulsions. J Colloid Interface Sci. 1992; 149:71–8.
Sakuma S, Hayashi M, Akashi M. Design of nanoparticles composed of graft copolymers for oral peptide delivery. Adv Drug Deliv Rev. 2001;47:21–37.
Patel HM, Túzél NS, Stevenson RW. Intracellular digestion of saturated and unsaturated phospholipid liposomes by mucosal cells: Possible mechanism of transport of liposomally entrapped macromolecules across the isolated vascularly perfused rabbit ileum. Biochim Biophys Acta. 1985; 839:40–9.
Tomizowal H, Aramaki V, Fujii Y. Uptake of phosphotidylserine liposomes by rat Peyer’s patches following intraluminal administration. Pharm Res. 1993; 10:549–52.
Iwanaga K, Ono S, Narioka K, Morimoto K, Kakemi M, Yamashita S, et al. Oral delivery of insulin by using surface coating liposomes improvement of stability of insulin in GI tract. Int J Pharm. 1997; 157:73–80.
Eiamtrakarn S, Itoh Y, Kishimoto J, Yoshikawa Y, Shibata N, Murakami, Takada K. Gastrointestinal mucoadhesive patch system (GI-MAPS) for oral administration of G-CSF, a model protein. Biomaterials. 2002; 23:145–52.
Bai JP, Chang LL, Guo JH. Effects of polyacrylic polymers on the degradation of insulin and peptide drugs by chymotrypsin and trypsin. J Pharm Pharmacol. 1996; 48:17–21.
Gu JM, Robinson JR, Leung SH. Binding of acrylic polymers to mucin/epithelial surface: Structure-property relationships. Crit Rev Ther Drug Carrier Syst. 1988; 5:21–67.
Woodley J. Bioadhesion: New possibilities for drug administration? Clin Pharmacokinet. 2001; 40:77–84.
Leitner VM, Walker GF, Schnurch AB. Thiolated polymers: Evidence for the formation of disulphide bonds with mucus glycoproteins. Eur J Pharm Biopharm. 2003; 56:207–14
Hussain N, Jani PU, Florence AT. Enhanced oral uptake of tomato lectin-conjugated nanoparticles in the rat. Pharm Res. 1997; 14:613–8.
Haas J, Lehr CM. Developments in the area of bioadhesive drug delivery systems. Exp Opin Biol Ther. 2002; 2:287–98.
Bernkop SA, Krajicek ME. Mucoadhesive polymers as platforms for peroral peptide delivery and absorption: Synthesis and evaluation of different chitosan-EDTA conjugates. J Control Release. 1998; 50:215–23.
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15/04/2021
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N. Patel, A. G. Amresh Gupta, Arpita Singh, Nitish Kumar, and Mohd. Aqil Siddiqui, “PROTEIN AND PEPTIDE BASED DRUG DELIVERY: PHARMACEUTICAL APPROACHES”, Int J Indig Herb Drug, pp. 40-48, Apr. 2021.
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