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Papers by Dr.Rubina Reichal C

Research paper thumbnail of Development and Validation of Spectrophotometric Method for Simultaneous Estimation of Gliclazide and Sitagliptin Phosphate Monohydrate in Bulk and Pharmaceutical Dosage Form

International Journal of Pharmacy and Pharmaceutical Sciences, May 4, 2015

Objective: The present study describes a simple, accurate, precise, specific and economical UV sp... more Objective: The present study describes a simple, accurate, precise, specific and economical UV spectrophotometric method for simultaneous estimation of Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) in bulk and pharmaceutical dosage form. Methods: The method was validated in terms of linearity, sensitivity, accuracy, precision, limit of detection and limit of quantification. The solvent used was methanol and the absorption maxima for Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) were found to be 226 nm and 267 nm respectively. Results: The percentage recovery of Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) were 99.8% and 99.64% respectively. The linear response was observed in the range of 7-27 µg/ml and 20-100 µg/ml with a correlation coefficient (r 2 Conclusion: The proposed method was successfully applied for the quantitative detection of Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) in Pharmaceutical dosage form.) of 0.996 and 0.998 for Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) respectively.

Research paper thumbnail of Formulation and Characterization of Phythosomal Topical Gel of Ocimum Basilicum

Research journal of pharmacy and technology, Oct 21, 2022

Research paper thumbnail of Formulation and characterization of gliclazide nanosuspension

RESEARCH JOURNAL OF PHARMACY AND TECHNOLOGY

Research paper thumbnail of Simultaneous estimation of Gliclazide and Sitagliptin Phosphate Monohydrate by Q-analysis method

The aim of the present study is to develop and validate simultaneous estimation of Gliclazide (GL... more The aim of the present study is to develop and validate simultaneous estimation of Gliclazide (GLZ) and Sitagliptin Phosphate Monohydrate (SPM) by Q-Analysis method. The method was simple, precise, accurate, reproducible and economical. Linearity was observed in concentration range of 5-25 µg/ml for Gliclazide and 20-100 µg/ml for Sitagliptin Phosphate monohydrate. Validation was performed as per ICH guidelines.

Research paper thumbnail of Dual release tablet: Clinical outcome and evaluation

Journal of chemical and pharmaceutical research, 2014

The goal in designing the bilayer tablets are suitable for the sequential release of two drugs in... more The goal in designing the bilayer tablets are suitable for the sequential release of two drugs in which one layer is immediate release as loading dose and second layer as maintenance dose. The Fixed Dose Combination (FDC) of two or more drugs in single dosage form, which is more safe and effective for single or different diseases. The bimodal release of formulation is mainly used to achieve rapid and extended release in a single dosage form. For good quality bilayer tablet, the machinery should be constructed as per GMP. The present study focuses the dual release tablets on different types of press, technology and the therapeutic benefits of bilayer tablets.

Research paper thumbnail of Formulation and characterization of ibuprofen sustained release tablets by solid dispersion technique

International Journal of pharma and Bio Sciences, 2019

The goal of any drug delivery system is to provide a therapeutic amount of drug to the proper sit... more The goal of any drug delivery system is to provide a therapeutic amount of drug to the proper site in the body to achieve promptly and then maintain the desired drug concentration. The drug-delivery system should deliver drug at a rate dictated by the needs of the body over a specified period of treatment. A number of systems containing hydrophobic and waxes were fabricated with drugs in to dosage forms with the aim of sustaining drug levels and hence drug action for an extended period of time. 3 Sustained release Sustained release systems include any drug delivery system that achieves low release of drug over an extended period of time sustained drug action at a determined rate by maintaining a relatively constant, effective drug level in the body with concomitant minimization of undesirable side effects. Site specific targeting In site specific targeting, the target is adjacent to or in the diseased organ or tissue. 2. Embedding the drug in a matrix 3. Coating the drug or dosage form containing the drug 4. Forming complexes of the drug with materials such as ion exchange resins. Partition coefficient and molecular size Partition coefficient and molecular size influence not only the permeation of a drug across the biological membranes, but also diffusion across or through a rate-controlling membrane or matrix. Drugs with extremely high partition coefficient (i.e., very oil-soluble) readily penetrate the membranes but unable to proceed further, while drugs with excessive aqueous solubility, i.e., low oil/water partition coefficients cannot penetrates the membranes. A balance in the partition coefficient is needed to give an optimum flux for permeation through the biological rate controlling members. Biological half-life The usual goal of an oral sustained release product is to maintain therapeutic blood levels over an extended period. To achieve this, drug must enter the circulation at approximately the same rate at which it is eliminated. The elimination rate is quantitatively described by the half-life(t1/2). Each drug has its own characteristic elimination rate, which is the sum of all elimination process, including metabolism, urinary excretion, and all other processes that permanently remove drug from the blood stream. Therapeutic compounds with short half-lives are excellent for sustained release preparations, since this can reduce dosing frequency. However, this is limited, in that drugs with very short half-lives may require excessively large Distribution The distribution of drugs into tissues can be an important factor in the overall drug elimination kinetics since it not only lowers the concentration of circulating drug but it also can be rate limiting in its equilibration with blood and extra cellular fluid. In the bound portion of a drug can be considered inactive and unable to cross membranes. Encapsulation dissolution control These methods generally involve coating individual particles or granules of drug with a slowly dissolving material. The coated particles can be compressed directly into tablets as in space tabs or placed in capsules as in the spanule products. Matrix dissolution control The reduced drug solubility plus larger particle size can be used to modify available rates. There is an upper restriction on the size of particles one can employ for the oralzoute while the low solubility approach will produce a changing dissolution are as the area for dissolution decrease. An alternate Reservoir devices In this system, a water insoluble polymeric material encloses a core of drug .Drug will partition in to the membrane and exchange with the fluid surrounding the particle or tablet. Additional drug will enter the membrane. Diffuse to the periphery, and exchange with surrounding media. 11 As important parameter in above equation is the partition coefficient which is defined as the concentration of drug in membrane over all concentration drug in the core. If the partition coefficient is high. The core will depleted of drug in a short time so that zero order release will be observed only over short segment of the time course of drug release. 10 1.5.3. Diffusion and dissolution controlled systems: The main feature is that the drug core is enclosed with a partially soluble membrane. Dissolution of part of the membrane allows for diffusion of the continued drug through pores is the polymer coat. The release profile of drug from this type of product can be described by the following equation: Release rate = AD(C1-C2)/1 important to the rate of diffusion, In addition, the amount of solvent in the matrix of the resin, as well as the structural rigidity of the resin, i.e. cross-linking, also influences the drug diffusion rate. For this reason, the porosity of the resin and the size of the bead of particle must be carefully controlled during the formulation process. 11 Drug release is triggered by penetration of eluting media into the matrix dissolving the drug, thereby creating channels through which diffusion takes place. A High tortuosity means that the effective average diffusion path is large. The porosity items takes in to account the space available for drug dissolution; an Higuchi' equation: Q = K2t ½ (3) Where Q is the amount of drug release at time t, and k 2 is the diffusion rate constant. 12 SOLID DISPERSION The term solid dispersion refers to a group of solid products consisting of at least two components, generally a hydrophilic matrix and a hydrophobic drug. ➢ Particles with higher porosity ➢ Drugs in amorphous state. Disadvantages of solid dispersion Though they increase the bio-availability of the drugs by increasing the solubility, their commercial use has been limited primarily because of • Recently, a method of measurement of viscosity of dissolution medium as the polymer dissolves from the solid dispersion as used to know the amount of drug release. This is Micro viscometry techniques(MVT). 20 Figure 2: Schematic representation of the bioavailability enhancement of poorly water soluble drug by solid dispersion technique. ARTHRITIS: "Arthritis" literally means "inflamed joints". Arthritis primarily affects the joints; it also attacks muscles and connective tissues of the surrounding organs. Arthritic disease stems from injuries, defects in the immune system, wear a tear on the joints, infections or genetic predisposition. 21 A. Osteoarthritis: A degenerative joint disease and the most common of arthritis and joint disorders, is the gradual deterioration of cartilage, usually in the larger, weight bearing joints such as the hips, knees, and spine. This wear and tear is normal side effects such as indigestion, stomach ulcers, headache, anxiety and dizziness. Chronotherapy provides ways of increasing the effectiveness and safety of arthritic medications.

Research paper thumbnail of Design and Evaluation of Dual Release Gliclazide and Sitagliptin Phosphate Inlay Tablet

World Journal of Pharmacy and Pharmaceutical Sciences, 2017

The objective of the present study is to design an inlay tablet of Sitagliptin Phosphate (core ta... more The objective of the present study is to design an inlay tablet of Sitagliptin Phosphate (core tablet) as immediate release and Gliclazide (cup portion) as sustained release, where in the dual modified release are selected for Type-II Diabetes Mellitus. The immediate release layer was prepared by direct compression method using different superdisintegrants and the sustained release layer was prepared by wet granulation method. The powder blend and the prepared tablets were evaluated for pre and post compression evaluation studies. The results found were within the pharmacopoeial limit. The in vitro dissolution study of the optimized formulation showed maximum percentage of release. The release kinetics studies revealed that the drug release of formulation 5 (FG5) followed Zero Order kinetics and showed high linearity (R 2 =0.989) and which the release mechanism followed by Fickian Diffusion. This study concluded that the inlayered tablets of Gliclazide and Sitagliptin Phosphate were the novel approach for the management of Type-II Diabetes Mellitus.

Research paper thumbnail of Anti-diabetic Drugs and Fixed Dose Combination Therapy

Research & Reviews: Journal of Pharmacy and Pharmaceutical Sciences, 2014

The Combination Therapy of different mechanism of action of drugs plays an important role in the ... more The Combination Therapy of different mechanism of action of drugs plays an important role in the measurement of Type II Diabetes Mellitus. The effect of diabetes develops specific complications of retinopathy, nephropathy, neuropathy, cardiac vascular diseases and cerebro vascular diseases. Combination therapy is beneficial for various diseases over monotherapy. The oral hypoglycemic drug combination therapy is most suitable for chronic disorder. Sulfonyl ureas, Alpha glucosidase inhibitors, Biguanides, Meglitinides and Thiazolidinediones are important in Combination Therapy. Bilayer tablet is suitable for sequential release of two drugs in combination, in which one layer is initial dose as immediate release and second layer is maintenance dose. This article explains the dual therapy of bilayer tablet and combination of anti-diabetic drugs which improves the patient compliance and provides synergistic effect.

Research paper thumbnail of RESEARCH AND REVIEWS: JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES Anti-diabetic Drugs and Fixed Dose Combination Therapy

Research paper thumbnail of Development and Validation of Spectrophotometric Method for Simultaneous Estimation of Gliclazide and Sitagliptin Phosphate Monohydrate in Bulk and Pharmaceutical Dosage Form

International Journal of Pharmacy and Pharmaceutical Sciences, May 4, 2015

Objective: The present study describes a simple, accurate, precise, specific and economical UV sp... more Objective: The present study describes a simple, accurate, precise, specific and economical UV spectrophotometric method for simultaneous estimation of Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) in bulk and pharmaceutical dosage form. Methods: The method was validated in terms of linearity, sensitivity, accuracy, precision, limit of detection and limit of quantification. The solvent used was methanol and the absorption maxima for Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) were found to be 226 nm and 267 nm respectively. Results: The percentage recovery of Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) were 99.8% and 99.64% respectively. The linear response was observed in the range of 7-27 µg/ml and 20-100 µg/ml with a correlation coefficient (r 2 Conclusion: The proposed method was successfully applied for the quantitative detection of Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) in Pharmaceutical dosage form.) of 0.996 and 0.998 for Gliclazide (GLZ) and Sitagliptin phosphate monohydrate (SPM) respectively.

Research paper thumbnail of Formulation and Characterization of Phythosomal Topical Gel of Ocimum Basilicum

Research journal of pharmacy and technology, Oct 21, 2022

Research paper thumbnail of Formulation and characterization of gliclazide nanosuspension

RESEARCH JOURNAL OF PHARMACY AND TECHNOLOGY

Research paper thumbnail of Simultaneous estimation of Gliclazide and Sitagliptin Phosphate Monohydrate by Q-analysis method

The aim of the present study is to develop and validate simultaneous estimation of Gliclazide (GL... more The aim of the present study is to develop and validate simultaneous estimation of Gliclazide (GLZ) and Sitagliptin Phosphate Monohydrate (SPM) by Q-Analysis method. The method was simple, precise, accurate, reproducible and economical. Linearity was observed in concentration range of 5-25 µg/ml for Gliclazide and 20-100 µg/ml for Sitagliptin Phosphate monohydrate. Validation was performed as per ICH guidelines.

Research paper thumbnail of Dual release tablet: Clinical outcome and evaluation

Journal of chemical and pharmaceutical research, 2014

The goal in designing the bilayer tablets are suitable for the sequential release of two drugs in... more The goal in designing the bilayer tablets are suitable for the sequential release of two drugs in which one layer is immediate release as loading dose and second layer as maintenance dose. The Fixed Dose Combination (FDC) of two or more drugs in single dosage form, which is more safe and effective for single or different diseases. The bimodal release of formulation is mainly used to achieve rapid and extended release in a single dosage form. For good quality bilayer tablet, the machinery should be constructed as per GMP. The present study focuses the dual release tablets on different types of press, technology and the therapeutic benefits of bilayer tablets.

Research paper thumbnail of Formulation and characterization of ibuprofen sustained release tablets by solid dispersion technique

International Journal of pharma and Bio Sciences, 2019

The goal of any drug delivery system is to provide a therapeutic amount of drug to the proper sit... more The goal of any drug delivery system is to provide a therapeutic amount of drug to the proper site in the body to achieve promptly and then maintain the desired drug concentration. The drug-delivery system should deliver drug at a rate dictated by the needs of the body over a specified period of treatment. A number of systems containing hydrophobic and waxes were fabricated with drugs in to dosage forms with the aim of sustaining drug levels and hence drug action for an extended period of time. 3 Sustained release Sustained release systems include any drug delivery system that achieves low release of drug over an extended period of time sustained drug action at a determined rate by maintaining a relatively constant, effective drug level in the body with concomitant minimization of undesirable side effects. Site specific targeting In site specific targeting, the target is adjacent to or in the diseased organ or tissue. 2. Embedding the drug in a matrix 3. Coating the drug or dosage form containing the drug 4. Forming complexes of the drug with materials such as ion exchange resins. Partition coefficient and molecular size Partition coefficient and molecular size influence not only the permeation of a drug across the biological membranes, but also diffusion across or through a rate-controlling membrane or matrix. Drugs with extremely high partition coefficient (i.e., very oil-soluble) readily penetrate the membranes but unable to proceed further, while drugs with excessive aqueous solubility, i.e., low oil/water partition coefficients cannot penetrates the membranes. A balance in the partition coefficient is needed to give an optimum flux for permeation through the biological rate controlling members. Biological half-life The usual goal of an oral sustained release product is to maintain therapeutic blood levels over an extended period. To achieve this, drug must enter the circulation at approximately the same rate at which it is eliminated. The elimination rate is quantitatively described by the half-life(t1/2). Each drug has its own characteristic elimination rate, which is the sum of all elimination process, including metabolism, urinary excretion, and all other processes that permanently remove drug from the blood stream. Therapeutic compounds with short half-lives are excellent for sustained release preparations, since this can reduce dosing frequency. However, this is limited, in that drugs with very short half-lives may require excessively large Distribution The distribution of drugs into tissues can be an important factor in the overall drug elimination kinetics since it not only lowers the concentration of circulating drug but it also can be rate limiting in its equilibration with blood and extra cellular fluid. In the bound portion of a drug can be considered inactive and unable to cross membranes. Encapsulation dissolution control These methods generally involve coating individual particles or granules of drug with a slowly dissolving material. The coated particles can be compressed directly into tablets as in space tabs or placed in capsules as in the spanule products. Matrix dissolution control The reduced drug solubility plus larger particle size can be used to modify available rates. There is an upper restriction on the size of particles one can employ for the oralzoute while the low solubility approach will produce a changing dissolution are as the area for dissolution decrease. An alternate Reservoir devices In this system, a water insoluble polymeric material encloses a core of drug .Drug will partition in to the membrane and exchange with the fluid surrounding the particle or tablet. Additional drug will enter the membrane. Diffuse to the periphery, and exchange with surrounding media. 11 As important parameter in above equation is the partition coefficient which is defined as the concentration of drug in membrane over all concentration drug in the core. If the partition coefficient is high. The core will depleted of drug in a short time so that zero order release will be observed only over short segment of the time course of drug release. 10 1.5.3. Diffusion and dissolution controlled systems: The main feature is that the drug core is enclosed with a partially soluble membrane. Dissolution of part of the membrane allows for diffusion of the continued drug through pores is the polymer coat. The release profile of drug from this type of product can be described by the following equation: Release rate = AD(C1-C2)/1 important to the rate of diffusion, In addition, the amount of solvent in the matrix of the resin, as well as the structural rigidity of the resin, i.e. cross-linking, also influences the drug diffusion rate. For this reason, the porosity of the resin and the size of the bead of particle must be carefully controlled during the formulation process. 11 Drug release is triggered by penetration of eluting media into the matrix dissolving the drug, thereby creating channels through which diffusion takes place. A High tortuosity means that the effective average diffusion path is large. The porosity items takes in to account the space available for drug dissolution; an Higuchi' equation: Q = K2t ½ (3) Where Q is the amount of drug release at time t, and k 2 is the diffusion rate constant. 12 SOLID DISPERSION The term solid dispersion refers to a group of solid products consisting of at least two components, generally a hydrophilic matrix and a hydrophobic drug. ➢ Particles with higher porosity ➢ Drugs in amorphous state. Disadvantages of solid dispersion Though they increase the bio-availability of the drugs by increasing the solubility, their commercial use has been limited primarily because of • Recently, a method of measurement of viscosity of dissolution medium as the polymer dissolves from the solid dispersion as used to know the amount of drug release. This is Micro viscometry techniques(MVT). 20 Figure 2: Schematic representation of the bioavailability enhancement of poorly water soluble drug by solid dispersion technique. ARTHRITIS: "Arthritis" literally means "inflamed joints". Arthritis primarily affects the joints; it also attacks muscles and connective tissues of the surrounding organs. Arthritic disease stems from injuries, defects in the immune system, wear a tear on the joints, infections or genetic predisposition. 21 A. Osteoarthritis: A degenerative joint disease and the most common of arthritis and joint disorders, is the gradual deterioration of cartilage, usually in the larger, weight bearing joints such as the hips, knees, and spine. This wear and tear is normal side effects such as indigestion, stomach ulcers, headache, anxiety and dizziness. Chronotherapy provides ways of increasing the effectiveness and safety of arthritic medications.

Research paper thumbnail of Design and Evaluation of Dual Release Gliclazide and Sitagliptin Phosphate Inlay Tablet

World Journal of Pharmacy and Pharmaceutical Sciences, 2017

The objective of the present study is to design an inlay tablet of Sitagliptin Phosphate (core ta... more The objective of the present study is to design an inlay tablet of Sitagliptin Phosphate (core tablet) as immediate release and Gliclazide (cup portion) as sustained release, where in the dual modified release are selected for Type-II Diabetes Mellitus. The immediate release layer was prepared by direct compression method using different superdisintegrants and the sustained release layer was prepared by wet granulation method. The powder blend and the prepared tablets were evaluated for pre and post compression evaluation studies. The results found were within the pharmacopoeial limit. The in vitro dissolution study of the optimized formulation showed maximum percentage of release. The release kinetics studies revealed that the drug release of formulation 5 (FG5) followed Zero Order kinetics and showed high linearity (R 2 =0.989) and which the release mechanism followed by Fickian Diffusion. This study concluded that the inlayered tablets of Gliclazide and Sitagliptin Phosphate were the novel approach for the management of Type-II Diabetes Mellitus.

Research paper thumbnail of Anti-diabetic Drugs and Fixed Dose Combination Therapy

Research & Reviews: Journal of Pharmacy and Pharmaceutical Sciences, 2014

The Combination Therapy of different mechanism of action of drugs plays an important role in the ... more The Combination Therapy of different mechanism of action of drugs plays an important role in the measurement of Type II Diabetes Mellitus. The effect of diabetes develops specific complications of retinopathy, nephropathy, neuropathy, cardiac vascular diseases and cerebro vascular diseases. Combination therapy is beneficial for various diseases over monotherapy. The oral hypoglycemic drug combination therapy is most suitable for chronic disorder. Sulfonyl ureas, Alpha glucosidase inhibitors, Biguanides, Meglitinides and Thiazolidinediones are important in Combination Therapy. Bilayer tablet is suitable for sequential release of two drugs in combination, in which one layer is initial dose as immediate release and second layer is maintenance dose. This article explains the dual therapy of bilayer tablet and combination of anti-diabetic drugs which improves the patient compliance and provides synergistic effect.

Research paper thumbnail of RESEARCH AND REVIEWS: JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES Anti-diabetic Drugs and Fixed Dose Combination Therapy