CUBOSOMES: A BOON FOR COSMECEUTICALS AND TOPICAL DRUG DELIVERY

Cubosomes are the nanoparticles of bicontinuous, lyotropic cubic phases, comprised of curved lipid bilayers organized into a three-dimensional honeycomb (cavernous) like structures separating two internal aqueous channels and large interfacial area. Cubic phases are optically isotropic, very viscous, and solid-like (crystalline) with cubic crystallographic symmetry. They can encapsulate hydrophilic, hydrophobic and amphiphilic drug substances, which are able to target and control the release of the bioactive agent. The cosmetic industry has made progress in the development of products to overcome skin as a barrier and deliver the actives through the skin effectively. Drug incorporated cubosomes shows some unique advantageous like, protection from chemical and physiological degradation, in vivo drug release in a controlled manner and improving the bioavailability of drug while reducing the side effect. Cubosomes are pharmacologically inactive, non-irritant, non-toxic, effective, and cosmetically acceptable. Topical drug delivery can deliver drugs selectively to the specific site; this avoids fluctuations of drug levels and improves patient compliance and suitable local and systemic therapeutic effects. Cubosomal topical drug formulation shows outstanding potential advantages for their controlled and sustained drug delivery. This review article mainly focuses on cosmetic and topical applications of cubosomes

REFERENCE-SCALED AVERAGE BIOEQUIVALENCE STUDY OF PAROXETINE UNDER FED CONDITIONS: VALIDATION OF SAMPLE SIZE ESTIMATION BY BOOTSTRAPPING TECHNIQUE

Objective: New technique was adopted and validated to estimate pivotal sample size from the pilot study data and to establish bioequivalence (BE) of highly variable drugs (HVD), paroxetine, a novel controlled release (CR) matrix tablets utilized ghatti Gum as a rate controlling membrane, in human subject under fed conditions by reference scale design. Methods: Bootstrapping technique was adopted to calculate the pivotal sample size from pilot study data for HVD paroxetine. The reliability and validation of the method were tested in a semi replicate three sequence (RRT, RTR, and TRR where T stand for test drug and R stand for reference drug) cross-over BE study in 24 healthy subjects under fed conditions. Results: The ratio of the pharmacokinetic (PK) metric obtained from the bootstrapping technique after log transformation was 1.04 for Cmax, 1.23 for AUCT, and 1.21 for AUCI with corresponding power of the study which was greater than 80% from pilot study data simulation. The ratio of the PK metric obtained from the reference scaling design in the present study was 1.00 for Cmax, 1.21 for AUCT, and 1.17 for AUCI. The upper limit of the Cmax, AUCT, and AUCI at 95% confidence limit was −0.143, −0.136, and −0.17, respectively. Conclusion: The test paroxetine CR formulation was bioequivalent with reference drug under fed conditions. The technique used for estimation of the sample size in the pivotal study was found reliable, and bootstrapping technique plays an important role in calculating sample size where intrasubject variability was immaterial

DEVELOPMENT AND EVALUATION OF MICROSPONGE GEL OF AN ANTIFUNGAL DRUG

Objective: The objective of the present study was to compare the release effect of Luliconazole from different polymeric (Hydrophilic and Hydrophobic) microsponges prepared using varying concentrations. The best microsponge was selected and incorporated into different gel (Natural and synthetic) and drug release is determined and compared with marketed formulation. Methods: Polymers such as EC, HPMC, Eudragit RSPO and PVA as emulsifier, and solvent DCM is used as solvent. Microsponge were prepared by using the quasi emulsion solvent diffusion technique. FTIR was studied to estimate the incompatibility. Microsponges were evaluated for SEM, particle size, drug content, and In vitro diffusion studies. Optimized microsponge incorporated gel was prepared by using different gel (flax seed gel and Aerosil gel) were evaluated for pH, spreadability, extrudability, drug content and in vitro diffusion studies. Results: Theresults obtainedshowed no physical-chemical incompatibility between the drug and the polymers. EC, HPMC and EC combination was found to be a suitable polymer compared to Eudragit RSPO and other combination in preparation of microsponge. From the evaluation of microsponge, the optimized F1 formulations was incorporated into different gel (flax seeds, aerosil) and compared with marketed formulation in which MG-I (flax seed gel) was considered as good topical anti-fungal microsponge gel based on there physical parameters and drug release kinetics. Conclusion: Microsponge and microsponge gel were successfully prepared for Luliconazole and their evaluation studies of each dosage form revealed that topically applied microsponge gel possess immense potential to control the release rate of medicament to improve the bioavailability as well as patient compliance

Oxidation of Indian Ilmenite: Thermodynamics and Kinetics Considerations

Natural Ilmenite (FeO.TiO2) is the primary source for the extraction of titanium dioxide (T1O2). Oxidation-reduction process is used for production of synthetic rutile from ilmenite by separation of Fe-oxides from TiO2. In this paper thermodynamics and kinetic aspects of oxidation reactions of ilmenite are discussed. Ilmenite with53% TiO2 used for investigation is a bit different from conventio-nal feed materials used for up-gradation processes. The slag route is generally employed for processing of low grade ilmenite with 58% TiO2 are used for production of syn-thetic rutile. Therefore detailed understanding oxidation - reduction behaviour of ilmenite is essential for selec-tion and optimisation of suitable up-gradation process

AN OVERVIEW: RECENT DEVELOPMENT IN TRANSDERMAL DRUG DELIVERY

The transdermal drug delivery system is an alternative method of administration of drugs. Most of the drugs are delivered by conventional oral, topical, intravenous, and intramuscular methods and are is of limited efficiency. However, now the clinical use of transdermal delivery is limited because of stratum cornea of the skin act as an effective barrier that limits the permeation of drugs through the skin. To overcome this disadvantage, there are Recent developments in transdermal drug delivery, such as the usage of nanoparticles i.e., liposomes, niosomes, transferosomes, ethosomes, nanoemulsion, virosomes, phytosomes, dendrimers, proniosomes, microneedles, and separable microneedles. This nanoparticulate transdermal drug delivery exhibits great potential to ensure drug permeation through the skin. They are very tiny carriers to detect by the immune system and further, they can be delivering the drug to the targeted site and also have the ability to deliver both hydrophilic and hydrophobic drugs by reducing the complexity. Nanoparticles are made of different materials and they’re very different in structure and chemical properties are discussed in this review article

FORMULATION AND EVALUATION OF MOUTH-DISSOLVING FILM OF AN H1 ANTIHISTAMINE DRUG

Objective: The objective of present work was to develop a Mouth dissolving film of Levocetirizine dihydrochloride drug by Solvent casting method using different natural polymers. The best polymer was selected on the basis of the release of the drug and disintegration time. Methods: Sodium alginate and Guar gum are used as a natural polymers. Starch is used as a disintegrant. Glycerol is used as a plasticizer. Citric acid is usedas a saliva-stimulating agent. Mannitol is used as a sweetener. Peppermint oil as a flavoring agent. Mouth-dissolving films were prepared by using the solvent casting method. Results: The compatibility study of the drug with different natural polymers was carried out. The IR spectral studies showed no interaction between drug and polymers. Obtained satisfactory results for Preformulation and post-formulation tests. Formulation F6 containing sodium alginate, F9 containing guar gum and F14 containing a combination ratio of (Sodium alginate: guar gum) showed good results throughout the study. The stability studies on the formulations F6, F9 and F14 indicates that there is no significant change in physical appearance, disintegration time and drug content release study. Conclusion: From the results, it was concluded that the Mouth dissolving films of Levocetirizine dihydrochloride containing natural polymer sodium alginate (F6) showed the least disintegration time (14.28 sec), highest dissolution rate (98.24%) than the formulation containing natural polymer guar gum and combination ratio of (Sodium alginate: guar gum)

MIXED SCALING APPROACH TO ESTABLISH BIOEQUIVALENCE OF LANSOPRAZOLE DELAYED RELEASE CAPSULE IN FASTING SPRINKLE WITH APPLE SAUCE STUDY IN HEALTHY SUBJECTS

Objective: The aim of the present study was to establish bioequivalence of highly variable generic lansoprazole (LSP) delayed release (DR) capsule,exploring minimal number of healthy volunteers by mixed scaling approach as oppose to average bioequivalence approach.Methods: This was an open-labeled, three-treatment, three-periods, three-sequences, single-dose, partial replicate crossover trial conducted in 36 +4 (stand by) healthy adult human subject in Indian origin.Results: Non-parametric Wilcoxon sign rank test at 95% confidence interval failed to conclude significance difference in T and t1/2 between theformulations. The intra subject standard deviation of the reference formulation was 0.340 for C, 0.249 for area under curve up to last measurabletime point (AUCT) and 0.244 for area under curve up to infinity time (AUCI) parameters. The reference scaling as proposed by Haider et al., 2008, wasapplied for Cmax, maxand constant scaling was applied for AUCT and AUCI metrics. No significance difference between two formulations were observedwhen data were analyzed by Analysis of Variance (p<0.05). Westlake 90% confidence limit, as well as two one-sided t-test as proposed by Schurimanand the Anderson-Hauck power analysis all fell under the predefine bioequivalence criteria for mixed scaling.Conclusion: The generic LSP DR capsules were found to bioequivalent with reference drug under fasting study with apple sauce with respect to rateand extent of absorption. The mixed scaling statistical analysis approach used to establish bioequivalence with a minimum number of subjects wasfound reliable and utilize 40 subjects as opposed to 110 subjects need to establish bioequivalence in traditional average bioequivalence approach.Keywords: Mixed scaling, Techniques, Non-parametric, Bioequivalence, Delayed release

Formulation and Evaluation of Bioadhesive Cyproheptadine Tablets

Purpose: To evaluate the effect of formulation variables on the bioadhesion and release properties of bioadhesive cyproheptadine hydrochloride tablets.Methods: Screening of polymers - hydroxypropyl methylcellulose, (HPMC), sodium carboxy methyl cellulose (CMC), and Carbopol 974p and 934p - in solution form were carried out by shear stress and detachment force measurement,based on Taguchi model, in order to determine their bioadhesion properties. Central composite design (CCD) was applied to optimize the combined effects of the polymers on release rate constant (K), diffusion coefficient (n), regression coefficient (R2) and detachment force of a sustained release tablet formulation of cyproheptadine hydrochloride containing also a prompt dose of the drug.Results: The shear stress of 3 % solution of HPMC was greater than that of an equivalent concentration of Carbopol 934P. The values of K, n, R2 and detachment force for the optimized formulation (F0) were 0.269, 0.696, 0.964 and 0.066 Newton (N), respectively, and showed good correlation with the predicted values, thus confirming the practicability and validity of the model.Conclusion: Gastric retention time can be increased for cyproheptadine hydrochloride by formulating it as a bioadhesive tablet that enhances the retention of the dosage form in the stomach and hence gastric absorption of the drug.Keywords: Cyproheptadine hydrochloride, Bioadhesive core tablet, Detachment force, Taguchi design, Central composite desig

EFFECT OF ANHEDRAL AND DIHEDRAL ON THE LATERAL DIRECTIONAL STATIC STABILITY OF THE AIRCRAFT

Developments and advancements in Aircraft industry have led to an increasing the stability and maneuverability of an aircraft. When the aircraft subjected to unbalanced force it needs the suitable wing to overcome the side slip and maneuverability of an aircraft. This work proposed a Dihedral and Anhedral wing simulation in XFLR5 software to increase the stability and maneuverability of an aircraft. XFLR5 analysis was then carried out for Dihedral and anhedral angles of 5deg, 10deg ,with side slip angles 2deg and 5deg. The aerofoil used in wing is NACA 4412 and in tail is 0009..Lateral-Directional Static Stability of 5,10 deg of both anhedral and dihedral wings are analyzed. The graphs are plotted between co-efficient of rolling moment and side slip angle ; co-efficient of yawing moment and side slip angle. The simulation is done in a free stream velocity of 60 m/s and inviscid flow. Anhedral is a negative dihedral angle .The anhedral reduces the dihedral effect bringing the wing\u27s roll characteristics into a more desirable performance envelope while keeping it stable yet maneuverable.Dihedral is the upward angle of an aircraft\u27s wings, which increases lateral stability in a bank by causing the lower wing to fly at a higher angle of attack than the higher wing

Impact of Capital Budgeting Decision on Profitability of Firm – Selected Listed Automobile Companies in India

Purpose: Profitability plays an important function in the business operations and determines the value by which a business is held. The study set to investigate the impact of capital budgeting decisions on profitability of Automobile firms. Capital budgeting particularly addressed five areas of the study that included capital budgeting decisions (acquisition of long-term assets, replacement of long-term assets, investment appraisal techniques, outsourcing expenditure and working capital decisions) had a biggest and significant effect on profitability of the organizations.   Methodology: This study basically involved survey of the Automobile Companies listed in NSE in India. Any business that seeks to invest its resources in a project without understanding the risks and returns involved would be held as irresponsible by its owners or shareholders. This study considered 10 companies are taken from Automobile sectors, which is listed in NSE. Correlation and paired T test were used.   Findings: This study basically involved survey of the Automobile Companies listed in NSE in India.The findings set up that there was relationship between the independent variables of capital budgeting decisions and profitability. The study was examined the outcome of capital budgeting Impact on profitability of listed firms in India. The independent variables for the study were Capital Budgeting and Profitability.   Research implications:  it is evident that Maruti and Tata Motors produced positive and statistically significant values for this study (high t-values (12.37 and 11.26), p =0.00) respectively. Eicher Motor resulted a Lowest but insignificant values (t= 2.11, p = 0.07).   Originality/Outcome: The study found that positive impact of capital budgeting on profitability of the firms under the study