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Papers by MANOJKUMAR K. MUNDE
International Journal of Pharmacy and Pharmaceutical Sciences
Many techniques have been developed to overcome the bioavailability problem of poorly soluble dru... more Many techniques have been developed to overcome the bioavailability problem of poorly soluble drugs. The nanonization is one of the techniques in that micronized particle is converted in nanoparticle. Several processes are applied for nanocrystal production, including precipitation, milling, high pressure homogenization and combination method. The nanocrystal formulation is administered via various routes like oral, intravenous, intramuscular, pulmonary, ocular and dermal but due to safety, patient compliance and ease of administration, oral drug delivery is preferred. There are two basic ways to prepare drug nanocrystals like “bottom-up” and “top-down” technologies. The present literature provides an overview of the achievement in improving the bioavailability of the poorly soluble drug by using different methods.
Asian Journal of Pharmacy and Technology
Nanosponges are the recent advances in nanotechnology. Nanosponge delivery system was originally ... more Nanosponges are the recent advances in nanotechnology. Nanosponge delivery system was originally developed for topical drug delivery. Nowadays it can also be used for oral delivery of drugs using water soluble and bio erodible polymers. Nanosponges are porous structures with a size of about a virus (average diameter below 1µm). Due to small size and porous nature; nanosponges can bind to poorly soluble drugs and improves their bioavailability. These nanosponges can circulate within body and interact with specific target site. At target site start releasing the drug in a controlled manner. Various techniques are reported for the preparation of Nanosponges as melt method, solvent diffusion method, solvent method, ultrasound assisted method and sonication etc. Nanosponges are the target specific drug delivery which has lesser side effects. Major advantage of nanosponges as it improves solubility of poorly soluble drug and exhibits higher drug loading as compared to other nanocarriers. ...
Indian Journal of Pharmaceutical Education and Research
Background: A novel stability indicating analytical method was developed and validated by High Pe... more Background: A novel stability indicating analytical method was developed and validated by High Performance Thin Layer Chromatography (HPTLC) using Design of experiment approach. The proposed method is useful for quantification of Metformin hydrochloride and Empagliflozin in bulk and its dosage forms simultaneously. Design of experiment approach was applied for optimization of chromatographic conditions. Materials and Methods: For optimization process independent variables were used as Isopropyl alcohol proportion in mobile phase, saturation time of chamber and distance travelled by mobile phase. Experiments were carried out on silica gel pre-coated plate using mobile phase as 2 % Ammonium acetate: Isopropyl alcohol: Triethylamine (4:6:0.1 v/v/v). Direct evaluation of chromatograms were done by TLC scanner with reflectance/absorbance mode set at 242 nm. Method was validated as per ICH Q2 (R1) requirements. Results: Correlation coefficients for calibration curves were found to be 0.985 and 0.988, the calibration curve is in concentration range of 5000-30000 ng band-1 and 125-750 ng band-1 for Metformin hydrochloride and Empagliflozin respectively. The method showed % recovery between 99.05 to 102.54 % for Metformin hydrochloride and 99.20 to 101.50 % for Empagliflozin. The method has a prospective to determine Metformin hydrochloride and Empagliflozin simultaneously. The Metformin hydrochloride and Empagliflozin were subjected to forced degradation studies like hydrolysis, oxidation, thermolysis and photodegradation. Conclusion: Proposed method has capacity to separate the Metformin hydrochloride and Empagliflozin in its degradation products. Hence one can apply this method effectively for routine analysis and during stability study as per regulatory requirements.
Indian Drugs
A stability indicating reversed-phase high-performance liquid-chromatographic method for analysis... more A stability indicating reversed-phase high-performance liquid-chromatographic method for analysis of empagliflozin was developed and validated as per the ICH guidelines. Statistical design of experiment was applied for optimization, where independent variables used were methanol proportions in mobile phase and flow rate. Experiment was carried out on an analytical reversed phase column Cosmosil C18 (250 × 4.6 mm, 5 µm). Based on the results obtained from these studies, suitable mobile phase with appropriate composition was selected and utilized for method development applying DoE approach. The mobile phase used was methanol: water (85:15 V/V). The flow rate was set at 0.8 mL min-1 and UV detection was carried out at 225 nm. The retention time of empagliflozin was found to be 4.259 min. The lower solvent consumption along with the short analytical run time (≤05 minute) provides a cost effective and environment friendly chromatographic procedure. The measured signal was shown to be pr...
Asian Journal of Pharmaceutical Analysis
The degradation of new drug ingredients and drug products in more severe settings than accelerate... more The degradation of new drug ingredients and drug products in more severe settings than accelerated conditions is referred to as forced degradation research. Forced degradation experiments were carried out to demonstrate the specificity of stability-indicating methodologies, providing insight into degradation pathways and drug degradation products, and assisting in the understanding of degradation product structures., identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability studies Statins, a type of lipid-lowering medication, are the most commonly prescribed and are an example of an unstable drug. In the presence of high temperatures and humidity, statins are susceptible to hydrolysis. As a result, the review discusses various studies of statin drug forced degradation studies. To describe the drug's intrinsic stability, the...
Research Journal of Pharmaceutical Dosage Forms and Technology, Mar 4, 2022
Gliptin is the class of antidiabetic medicine also called as dipeptidylpeptidase-4. DPP-4 (dipept... more Gliptin is the class of antidiabetic medicine also called as dipeptidylpeptidase-4. DPP-4 (dipeptidyl peptidase-4) inhibitors (or "gliptins") represent a class of oral anti-hyperglycaemic agents that inhibit the enzyme DPP-4, thus augmenting the biological activity of the "incretin" hormones (glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]) Sitagliptin, Saxagliptin, Alogliptin, Linagliptin, Vildagliptin are the Gliptin class inhibitor for the treatment of type 2 diabetes mellitus and they decrease the breakdown of the incretin hormones such as glucagon like peptide 1 (GLP-1). All together gliptins have a good oral bioavailability which is not significantly influenced by food intake. PK/pharmacodynamics characteristics, that is, sufficiently prolonged half-life and sustained DPP-4 enzyme inactivation, generally allow one single oral administration per day for the management of T2DM; the only exception is vildagliptin for which a twice-daily administration is recommended because of a shorter half-life DPP-4. This paper is an updated review, providing an analysis of both the similarities and differences between the various compounds known as gliptins, currently used in the clinic (sitagliptin, saxagliptin, alogliptin linagliptin and vildagliptin). This paper discusses the pharmacokinetic and pharmacodynamic characteristics of gliptins. In this review we complied analytical method development and determination of the Gliptin inhibitors. Table no.1, 2, 3, 4, 5, shows the analytical method development and validation of Sitagliptin, Saxagliptin, Alogliptin, Linagliptin, and Vildagliptin alone and with its combination by the HPCL method.
Research Journal of Pharmacy and Technology, 2020
SGLT-2 is the newly developed class of antidiabetic medicine also called as gliflozins. Empaglifl... more SGLT-2 is the newly developed class of antidiabetic medicine also called as gliflozins. Empagliflozin, dapagliflozin and canagliflozin are the SGLT-2 class inhibitors for the treatment of type II diabetes mellitus. SGLT-2 inhibitors shows the 82% of plasma protein binding, 36.8% of partitioning of red blood cells, 78% of bioavailability, 5.6 to 13.1 hrs half life in oral route of administration. In this review we complied analytical methods for the development and determination of the SGLT-2 inhibitors. Table no. 1, 2, 3 shows the analytical method development and validation of empagliflozin dapagliflozin and canagliflozin alone and with its combination by the HPLC method respectively also table no. 4 shows the various formulations available in SGLT-2 Inhibitors.
European Journal of Chemistry, 2011
Three simple, sensitive and accurate spectrophotometric methods (A, B and C) were developed to de... more Three simple, sensitive and accurate spectrophotometric methods (A, B and C) were developed to determine doxofylline in bulk and in its dosage forms. Method A is based on charge-transfer complex formation of the drug with p-chloranilic acid. Method B involves the formation of colored chloroform extractable ion-pair complex of the drug with bromophenol blue under acidic condition. Method C is based on ternary complex formation of the drug with molybdenum(V) thiocyanate binary complex. The colored products are quantitated spectrophotometrically at 540, 390 and 690 nm by methods A, B and C, respectively. The variables, which affected the reactions were carefully studied and optimized. The linear ranges for the proposed methods were 4-32 μg/mL (method A & B) and 2-16 μg/mL (method C). Analytical performance of the methods was statistically validated. The proposed methods were successfully applied to the analysis of doxofylline in its dosage forms and were found to be comparable with that of reference method. Doxofylline Ion association complex Charge transfer complex Ternary complex Spectrophotometric analysis Doxofylline analysis
Pharmaceutical Development and Technology, 2009
Inclusion complexes of gliclazide with beta-cyclodextrin were prepared using different two method... more Inclusion complexes of gliclazide with beta-cyclodextrin were prepared using different two methods: neutralization and recrysstalization. Host-guest interactions were studied in the solid state by X-ray diffractometry and infrared spectroscopy. The stability constant between gliclazide and beta-cyclodextrin was calculated from the phase solubility diagram. It was found that the neutralization technique and a solid complex of gliclazide with beta-cyclodextrin in a molar ratio of 1.5:1 could be used to prepare the amorphous state of drug inclusion complexes. The dissolution rates of gliclazide from the inclusion complex made by neutralization was much faster than the pure drug, physical mixture of drug and cyclodextrin, recyristalization system and also comparable to the data reported in literature. Results of this report indicate that beta-cyclodextrin could be useful for the solid gliclazide formulations as it may results in a more rapid and uniform release of the drug.
International Journal of Pharmacy and Pharmaceutical Sciences, Apr 1, 2023
Many techniques have been developed to overcome the bioavailability problem of poorly soluble dru... more Many techniques have been developed to overcome the bioavailability problem of poorly soluble drugs. The nanonization is one of the techniques in that micronized particle is converted in nanoparticle. Several processes are applied for nanocrystal production, including precipitation, milling, high pressure homogenization and combination method. The nanocrystal formulation is administered via various routes like oral, intravenous, intramuscular, pulmonary, ocular and dermal but due to safety, patient compliance and ease of administration, oral drug delivery is preferred. There are two basic ways to prepare drug nanocrystals like "bottom-up" and "top-down" technologies. The present literature provides an overview of the achievement in improving the bioavailability of the poorly soluble drug by using different methods.
International Journal of Pharmacy and Pharmaceutical Sciences
Many techniques have been developed to overcome the bioavailability problem of poorly soluble dru... more Many techniques have been developed to overcome the bioavailability problem of poorly soluble drugs. The nanonization is one of the techniques in that micronized particle is converted in nanoparticle. Several processes are applied for nanocrystal production, including precipitation, milling, high pressure homogenization and combination method. The nanocrystal formulation is administered via various routes like oral, intravenous, intramuscular, pulmonary, ocular and dermal but due to safety, patient compliance and ease of administration, oral drug delivery is preferred. There are two basic ways to prepare drug nanocrystals like “bottom-up” and “top-down” technologies. The present literature provides an overview of the achievement in improving the bioavailability of the poorly soluble drug by using different methods.
Asian Journal of Pharmacy and Technology
Nanosponges are the recent advances in nanotechnology. Nanosponge delivery system was originally ... more Nanosponges are the recent advances in nanotechnology. Nanosponge delivery system was originally developed for topical drug delivery. Nowadays it can also be used for oral delivery of drugs using water soluble and bio erodible polymers. Nanosponges are porous structures with a size of about a virus (average diameter below 1µm). Due to small size and porous nature; nanosponges can bind to poorly soluble drugs and improves their bioavailability. These nanosponges can circulate within body and interact with specific target site. At target site start releasing the drug in a controlled manner. Various techniques are reported for the preparation of Nanosponges as melt method, solvent diffusion method, solvent method, ultrasound assisted method and sonication etc. Nanosponges are the target specific drug delivery which has lesser side effects. Major advantage of nanosponges as it improves solubility of poorly soluble drug and exhibits higher drug loading as compared to other nanocarriers. ...
Indian Journal of Pharmaceutical Education and Research
Background: A novel stability indicating analytical method was developed and validated by High Pe... more Background: A novel stability indicating analytical method was developed and validated by High Performance Thin Layer Chromatography (HPTLC) using Design of experiment approach. The proposed method is useful for quantification of Metformin hydrochloride and Empagliflozin in bulk and its dosage forms simultaneously. Design of experiment approach was applied for optimization of chromatographic conditions. Materials and Methods: For optimization process independent variables were used as Isopropyl alcohol proportion in mobile phase, saturation time of chamber and distance travelled by mobile phase. Experiments were carried out on silica gel pre-coated plate using mobile phase as 2 % Ammonium acetate: Isopropyl alcohol: Triethylamine (4:6:0.1 v/v/v). Direct evaluation of chromatograms were done by TLC scanner with reflectance/absorbance mode set at 242 nm. Method was validated as per ICH Q2 (R1) requirements. Results: Correlation coefficients for calibration curves were found to be 0.985 and 0.988, the calibration curve is in concentration range of 5000-30000 ng band-1 and 125-750 ng band-1 for Metformin hydrochloride and Empagliflozin respectively. The method showed % recovery between 99.05 to 102.54 % for Metformin hydrochloride and 99.20 to 101.50 % for Empagliflozin. The method has a prospective to determine Metformin hydrochloride and Empagliflozin simultaneously. The Metformin hydrochloride and Empagliflozin were subjected to forced degradation studies like hydrolysis, oxidation, thermolysis and photodegradation. Conclusion: Proposed method has capacity to separate the Metformin hydrochloride and Empagliflozin in its degradation products. Hence one can apply this method effectively for routine analysis and during stability study as per regulatory requirements.
Indian Drugs
A stability indicating reversed-phase high-performance liquid-chromatographic method for analysis... more A stability indicating reversed-phase high-performance liquid-chromatographic method for analysis of empagliflozin was developed and validated as per the ICH guidelines. Statistical design of experiment was applied for optimization, where independent variables used were methanol proportions in mobile phase and flow rate. Experiment was carried out on an analytical reversed phase column Cosmosil C18 (250 × 4.6 mm, 5 µm). Based on the results obtained from these studies, suitable mobile phase with appropriate composition was selected and utilized for method development applying DoE approach. The mobile phase used was methanol: water (85:15 V/V). The flow rate was set at 0.8 mL min-1 and UV detection was carried out at 225 nm. The retention time of empagliflozin was found to be 4.259 min. The lower solvent consumption along with the short analytical run time (≤05 minute) provides a cost effective and environment friendly chromatographic procedure. The measured signal was shown to be pr...
Asian Journal of Pharmaceutical Analysis
The degradation of new drug ingredients and drug products in more severe settings than accelerate... more The degradation of new drug ingredients and drug products in more severe settings than accelerated conditions is referred to as forced degradation research. Forced degradation experiments were carried out to demonstrate the specificity of stability-indicating methodologies, providing insight into degradation pathways and drug degradation products, and assisting in the understanding of degradation product structures., identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability studies Statins, a type of lipid-lowering medication, are the most commonly prescribed and are an example of an unstable drug. In the presence of high temperatures and humidity, statins are susceptible to hydrolysis. As a result, the review discusses various studies of statin drug forced degradation studies. To describe the drug's intrinsic stability, the...
Research Journal of Pharmaceutical Dosage Forms and Technology, Mar 4, 2022
Gliptin is the class of antidiabetic medicine also called as dipeptidylpeptidase-4. DPP-4 (dipept... more Gliptin is the class of antidiabetic medicine also called as dipeptidylpeptidase-4. DPP-4 (dipeptidyl peptidase-4) inhibitors (or "gliptins") represent a class of oral anti-hyperglycaemic agents that inhibit the enzyme DPP-4, thus augmenting the biological activity of the "incretin" hormones (glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]) Sitagliptin, Saxagliptin, Alogliptin, Linagliptin, Vildagliptin are the Gliptin class inhibitor for the treatment of type 2 diabetes mellitus and they decrease the breakdown of the incretin hormones such as glucagon like peptide 1 (GLP-1). All together gliptins have a good oral bioavailability which is not significantly influenced by food intake. PK/pharmacodynamics characteristics, that is, sufficiently prolonged half-life and sustained DPP-4 enzyme inactivation, generally allow one single oral administration per day for the management of T2DM; the only exception is vildagliptin for which a twice-daily administration is recommended because of a shorter half-life DPP-4. This paper is an updated review, providing an analysis of both the similarities and differences between the various compounds known as gliptins, currently used in the clinic (sitagliptin, saxagliptin, alogliptin linagliptin and vildagliptin). This paper discusses the pharmacokinetic and pharmacodynamic characteristics of gliptins. In this review we complied analytical method development and determination of the Gliptin inhibitors. Table no.1, 2, 3, 4, 5, shows the analytical method development and validation of Sitagliptin, Saxagliptin, Alogliptin, Linagliptin, and Vildagliptin alone and with its combination by the HPCL method.
Research Journal of Pharmacy and Technology, 2020
SGLT-2 is the newly developed class of antidiabetic medicine also called as gliflozins. Empaglifl... more SGLT-2 is the newly developed class of antidiabetic medicine also called as gliflozins. Empagliflozin, dapagliflozin and canagliflozin are the SGLT-2 class inhibitors for the treatment of type II diabetes mellitus. SGLT-2 inhibitors shows the 82% of plasma protein binding, 36.8% of partitioning of red blood cells, 78% of bioavailability, 5.6 to 13.1 hrs half life in oral route of administration. In this review we complied analytical methods for the development and determination of the SGLT-2 inhibitors. Table no. 1, 2, 3 shows the analytical method development and validation of empagliflozin dapagliflozin and canagliflozin alone and with its combination by the HPLC method respectively also table no. 4 shows the various formulations available in SGLT-2 Inhibitors.
European Journal of Chemistry, 2011
Three simple, sensitive and accurate spectrophotometric methods (A, B and C) were developed to de... more Three simple, sensitive and accurate spectrophotometric methods (A, B and C) were developed to determine doxofylline in bulk and in its dosage forms. Method A is based on charge-transfer complex formation of the drug with p-chloranilic acid. Method B involves the formation of colored chloroform extractable ion-pair complex of the drug with bromophenol blue under acidic condition. Method C is based on ternary complex formation of the drug with molybdenum(V) thiocyanate binary complex. The colored products are quantitated spectrophotometrically at 540, 390 and 690 nm by methods A, B and C, respectively. The variables, which affected the reactions were carefully studied and optimized. The linear ranges for the proposed methods were 4-32 μg/mL (method A & B) and 2-16 μg/mL (method C). Analytical performance of the methods was statistically validated. The proposed methods were successfully applied to the analysis of doxofylline in its dosage forms and were found to be comparable with that of reference method. Doxofylline Ion association complex Charge transfer complex Ternary complex Spectrophotometric analysis Doxofylline analysis
Pharmaceutical Development and Technology, 2009
Inclusion complexes of gliclazide with beta-cyclodextrin were prepared using different two method... more Inclusion complexes of gliclazide with beta-cyclodextrin were prepared using different two methods: neutralization and recrysstalization. Host-guest interactions were studied in the solid state by X-ray diffractometry and infrared spectroscopy. The stability constant between gliclazide and beta-cyclodextrin was calculated from the phase solubility diagram. It was found that the neutralization technique and a solid complex of gliclazide with beta-cyclodextrin in a molar ratio of 1.5:1 could be used to prepare the amorphous state of drug inclusion complexes. The dissolution rates of gliclazide from the inclusion complex made by neutralization was much faster than the pure drug, physical mixture of drug and cyclodextrin, recyristalization system and also comparable to the data reported in literature. Results of this report indicate that beta-cyclodextrin could be useful for the solid gliclazide formulations as it may results in a more rapid and uniform release of the drug.
International Journal of Pharmacy and Pharmaceutical Sciences, Apr 1, 2023
Many techniques have been developed to overcome the bioavailability problem of poorly soluble dru... more Many techniques have been developed to overcome the bioavailability problem of poorly soluble drugs. The nanonization is one of the techniques in that micronized particle is converted in nanoparticle. Several processes are applied for nanocrystal production, including precipitation, milling, high pressure homogenization and combination method. The nanocrystal formulation is administered via various routes like oral, intravenous, intramuscular, pulmonary, ocular and dermal but due to safety, patient compliance and ease of administration, oral drug delivery is preferred. There are two basic ways to prepare drug nanocrystals like "bottom-up" and "top-down" technologies. The present literature provides an overview of the achievement in improving the bioavailability of the poorly soluble drug by using different methods.