Formulation Of Matrix Tablets Drug Delivery Systems Biology Essay

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The goal of any drug delivery system is to provide a therapeutic amount of drug to the proper site in the body and also to achieve and maintain the desired plasma concentration of the drug for a particular period of time. Such limitations of the conventional dosage forms have paved way to an era of controlled and novel drug delivery systems.

Glipizide and Glimepiride, anti diabetic drugs, have been chosen as a model drugs in the formulation of matrix tablets drug delivery systems for the present work.

The formulated matrix tablets are economical to alter beneficially the properties of the existing drugs than developing new drug entities. Thus these anti diabetic drugs have been chosen.

For the above formulations, Aloe barbadensis miller, Guar Gum, Povidone were blended in varying proportions with Glipizide and Glimepiride.

UV and FTIR spectrums proved the compatibility of Glipizide and Glimepiride with the polymers used (Aloe barbadensis miller, Guar Gum, Povidone).

Matrix Tablets of Glipizide and Glimepiride with Aloe barbadensis miller leaf mucilage and Povidone in combination shown good physical appearance and uniformity of weight as per I.P specifications

Hardness and Friability of Glipizide and Glimepiride with Aloe barbadensis miller leaf mucilage and Povidone matrix tablets (GPAP and GMAP) indicates the good compactness and mechanical strength

The content uniformity of Glipizide and Glimepiride with Aloe barbadensis miller leaf mucilage and Povidone matrix tablets (GPAP and GMAP) revealed that the drug was uniformly mixed in the polymers.

In-vitro dissolution studies revealed that the release rate of Glipizide and Glimepiride from matrix tablets were retarded with the increase in the proportion of Aloe barbadensis miller leaves mucilage and Povidone.

The SEM photographs of the optimized GPAP-5 tablet's dissolution (at different intervals) revealed that drug released from GPAP-5 matrix tablets by diffusion and erosion.

The kinetic data showed that the drug release from formulations was mainly due to diffusion and erosion mechanism as depicted by strong positive values of regression coefficient (r) obtained from the graph. Regression coefficient values indicated that the drug release pattern from Glipizide and Glimepiride with Aloe barbadensis miller leaf mucilage and Povidone matrix tablets matches nearly zero order release pattern. Korsmeyer Peppa's plot indicates that almost all the formulations of Glipizide and Glimepiride with Aloe barbadensis miller leaf mucilage and Povidone matrix tablets followed Fickian release behavior.

The prepared Glipizide and Glimepiride with Aloe barbadensis miller leaf mucilage and Povidone matrix tablets were characterized for their flow properties, physicochemical properties, in-vitro drug release studies, in-vivo bioavailability studies. Almost all the formulations showed fairly acceptable values for all the parameters evaluated. The results were discussed in the chapter 5.

The Glipizide and Glimepiride with Aloe barbadensis miller leaf mucilage and Povidone matrix tablets showed good release patterns and steady plasma concentrations for longer periods. The cumulative release of GPAP-5 with marketed tablets shown the release form GPAP-5 is identical with marketed tablets. Thus the prepared GPAP-5 matrix tablets proved to be a potential candidate as a controlled release drug delivery device in this era of patenting novel and controlled release formulations.

Mean % reduced blood glucose levels with GPAP-5 shown very highly significant values (P***<0.001) compared to Glipizide by oral route.

Mean % reduced blood glucose levels with GMAP-5 shown very highly significant values (P***<0.001) compared to Glimepiride by oral route.

6.1.2. Summary of Transdermal Patches

Matrix type transdermal patches have been successfully developed to deliver various drugs via skin into the systemic circulation with considerable biomedical benefits.

Glipizide and Glimepiride, anti-diabetic drugs have been chosen as a model drugs in the formulation of transdermal drug delivery systems in the present work.

The formulated matrix type transdermal patches are economical to other polymers which are generally used for making transdermal patches. Repetitive administration of drugs will be minimized by formulating these anti-diabetic drugs in the form of transdermal patches.

Transdermal patches were prepared by using Ficus bengalensis, Ficus carica, Ficus glomerata fruits mucilage and Poly vinyl Pyrrolidone as matrix forming materials in varying proportions with Glipizide and Glimepiride.

Physical parameters viz., Thickness, Tensile strength, Elongation, Folding endurance, Moisture content, Elongation brake, Moisture uptake and Drug content were found to be satisfactory

When the patches were applied to the Rabbit's back there was no visible erythema or edema was observed, indicates non irritating behavior of patches and polymers used.

The in vitro skin permeation of Glipizide and Glimepiride from transdermal patches in controlled manner revealed the feasibility of Ficus bengalensis, Ficus carica, Ficus glomerata fruits mucilage as matrix formers for making transdermal patches.

Mean % reduced Blood glucose levels with GPFGP-5 patches shown highly significant values (P**<0.01) compared to control (normal).

Mean % reduced Blood glucose levels with GMFGP-5 patches shown highly significant values (P**<0.01) when compared to normal control. The pharmacokinetic values of GPAP-5 were as follows.

The Cmax was found to be 0.91 (µg/mL), the Tmax was found to be 6.0 h, the (AUC) was found to be 15.86 µg.h/mL, (AUMC) was found to be 69.25 µg.h/mL, the Ka was found to 0.156 h-1,the Mean Resident Time was found to be12.33 h and the bioavailability was found to be114.8%.

6.2. CONCLUSION

6.2.1. Conclusion of matrix tablets

Matrix technique is gaining an importance in current days as a simplest technique for a controlled release of drugs. If a drug has right mix of physical chemistry and pharmacology, matrix tablets have a wide range of advantages. Many researches are going on in the present day to discover an economical and effective polymer to release drug by this system. After preparation of matrix tablets, they are evaluated for physicochemical studies, in vitro release studies, in vivo release studies, human studies and stability studies. But all the prepared and evaluated matrix tablets must receive approval from FDA before sale.

The aim of this study was to explore the feasibility of matrix tablets of Glipizide and Glimepiride to Diabetes Mellitus. A satisfactory attempt was made to develop matrix tablets by using economical, easily available and natural polymer Aloe barbadensis Miller leaves mucilage.

From the reproducible results obtained from the executed experiments it can be concluded that:

Biocompatible and natural polymers like Aloe barbadensis Miller leaf mucilage can be used to formulate matrix tablets of Glipizide and Glimepiride

The release of Glipizide and Glimepiride from the formulations is retarded as the proportions of Aloe barbadensis miller leaves mucilage increased

In vitro drug release studies showed a steady release of Glipizide and Glimepiride from the formulated matrix tablets.

Formulations GPAP-5 and GMAP-5 showed a better controlled release

The formulation GPAP-5 matrix tablets showed a kinetic release profile similar to the theoretical controlled release profile of the drug and could be regarded as the optimum formulation.

The in vivo studies revealed that the oral bioavailability of the drug increased than that of conventional dosage form.

Non Fickian diffusion was the drug release mechanism from the formulated matrix tablets. Aloe barbadensis miller leaves mucilage and Povidone in combination appears to be suitable for use as a pharmaceutical excipient in the formulation and manufacture of controlled release matrix tablets because of its good swelling, good flow properties and suitability for direct compression formulations.

It was concluded from the dissolution study, that the dried Aloe barbadensis miller leaves mucilage and Povidone combination can be used as an excipient for making controlled release matrix tablets.

The in-vivo tests in rabbit proved that the formulated matrix tablets could be a promising, satisfactory for controlled release.

Accelerated stability studies, proved that the formulation GPAP-5 is quite stable.

6.2.2. Conclusion of transdermal patches

Transdermal drug delivery systems plays a potential role in controlled release is being globally exploited by the scientists with high rate of attainment. If a drug has right mix of physical chemistry and pharmacology, transdermal delivery is a remarkable effective route of administration. Due to large advantages of the TDDS, many new researches are going on in the present day to incorporate newer drugs via the system. A transdermal patch has several basic components like drug reservoirs, liners, adherents, permeation enhancers, backing laminates, plasticizers and solvents, which play a vital role in the release of drug via skin. After preparation of transdermal patches, they are evaluated for physicochemical studies, in vitro permeation studies, skin irritation studies, animal studies, human studies and stability studies. But all prepared and evaluated transdermal patches must receive approval from FDA before sale. Future developments of TDDSs will likely focus on the increased control of therapeutic regimens and the continuing expansion of drugs available for use. Transdermal dosage forms may provide clinicians an opportunity to offer more therapeutic options to their patients to optimize their care.

From the experimental results it can be concluded that,

Biocompatible and natural polymers like Ficus bengalensis, Ficus carica and Ficus glomerata fruits mucilage can be used to formulate matrix type transdermal patches.

The permeation of Glipizide and Glimepiride from the formulations is retarded as the proportions of mucilage increased.

In vitro permeation studies showed a steady release of Glipizide and Glimepiride from the formulated matrix transdermal patches.

Formulations GPFGP-5 and GMFGP-5 showed a better controlled release

Ficus bengalensis, Ficus carica and Ficus glomerata fruits mucilage appears to be suitable for use as a matrix former in the formulation matrix type transdermal patches.

Ficus glomerata fruits mucilage and Povidone combination found to be suitable for use as a matrix former in the formulation and manufacture of controlled release matrix transdermal patches.

It can be concluded that the prepared transdermal patches were having satisfactory physical parameters and permeation profiles. Hence it is concluded that Glimepiride transdermal patches can be prepared with Ficus glomerata fruit mucilage and Povidone which are economical and effective.

Similarly Glimepiride transdermal patches can be prepared with Ficus glomerata fruit mucilage and Povidone which are economical and effective.

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