NON INVASIVE DELIVERY OF PROTEIN AND PEPTIDE DRUGS: A REVIEW

Till recent, injections remained the most common route for administration of protein and peptide drugs because of their poor bioavailability in the other routes. Because it is generally recognized that injection based delivery is a major impediment to the commercial success of therapeutic proteins and peptides, research in both academia and industry continues to focus on ways to overcome this problem. Possible non-parenteral administration routes for delivery of peptide and protein drugs include oral, nasal, ocular, transdermal, rectal, colonic, and vaginal route. The large surface area associated with most of these routes makes them attractive targets for drug delivery. While non-invasive administration by these routes is considered a more logical and achievable option for local treatment regimens, systemic delivery of proteins and peptides is significantly more challenging. In spite of effort made on the development of drugs for these routes, most of the successes fail to address how the technology will be transformed to a commercial product. The only notable exceptions have been the successful commercialization of nasal formulations for systemic delivery of a limited number of therapeutic peptides, and recent regulatory approvals of both pulmonary and buccal delivery systems for systemic delivery of insulin and an oral formulation of a small peptide analog, cyclosporine, have been commercialized. The present review aims to discuss the potential non-invasive routes of protein and peptide drug delivery. The factors which will affect drug transport and the bioavailability of proteins administered through these routes is also emphasize

NON INVASIVE DELIVERY OF PROTEIN AND PEPTIDE DRUGS: A REVIEW

Till recent, injections remained the most common route for administration of protein and peptide drugs because of their poor bioavailability in the other routes. Because it is generally recognized that injection based delivery is a major impediment to the commercial success of therapeutic proteins and peptides, research in both academia and industry continues to focus on ways to overcome this problem. Possible non-parenteral administration routes for delivery of peptide and protein drugs include oral, nasal, ocular, transdermal, rectal, colonic, and vaginal route. The large surface area associated with most of these routes makes them attractive targets for drug delivery. While non-invasive administration by these routes is considered a more logical and achievable option for local treatment regimens, systemic delivery of proteins and peptides is significantly more challenging. In spite of effort made on the development of drugs for these routes, most of the successes fail to address how the technology will be transformed to a commercial product. The only notable exceptions have been the successful commercialization of nasal formulations for systemic delivery of a limited number of therapeutic peptides, and recent regulatory approvals of both pulmonary and buccal delivery systems for systemic delivery of insulin and an oral formulation of a small peptide analog, cyclosporine, have been commercialized. The present review aims to discuss the potential non-invasive routes of protein and peptide drug delivery. The factors which will affect drug transport and the bioavailability of proteins administered through these routes is also emphasize

Formulation and Evaluation of Oral Disintegrating Tablets of Lamotrigine Solid Dispersions: Oral dispersible tablets

Lamotrigine is used in the treatment of CNS disorders, particularly epilepsy; pain; oedema; multiple sclerosis and psychiatric indications including bipolar disorder. Lamotrigine belongs to biopharmaceutical classification systems; BCS class II (Low solubility & High permeability). In addition, it requires immediate therapeutic action. Hence, the main objective of this study is to improve the solubility by solid dispersion technique and formulate it as oral disintegrating tablets (ODT) to avert the problems of swallowing and to provide rapid onset of action. Lamotrigine solid dispersion was prepared by using Tween 80 and Gelucire 44/14 as solubility enhancers and formulated it into ODT by direct compression technique using different concentrations of Kyron T-314, Kyron T-154, and Kyron T-104 as cross linked polymers. The tablets were evaluated for various parameters and the results were found to be satisfactory. The batches of LMTK314 (2), LMGK314 (2) were selected as optimized batch containing Kyron T-314 as super disintegrant in 2% concentration, as they showed 100% drug release in 8 minutes and 6 minutes with a disintegration time of 11 and 9 seconds respectively. Upon comparison of dissolution profiles of optimized formulae LMTK314 (2), LMGK314 (2) with a marketed product, it proved that the optimized formulae had shown better dissolution. The optimized formulations were subjected to stability studies for three months as per ICH guidelines and showed physical stability with insignificant change in the hardness, disintegration time, drug content and in vitro drug release