Volume 1 - Issue 1 - Published Papers

  • Title: Formulation Development and Evaluation of Duloxetine Hydrochloride Mucoadhesive Patch System for Oral Drug Delivery

    Abstract: Design, develop and evaluate gastrointestinal mucoadhesive patch system (GIMAPS) of an anti – depressant for oral drug delivery. With the objective of using innovative approach to administer Duloxetine hydrochloride (DLX), formulations were designed as GIMAPS by ensuring drug protection in acidic environment and giving a controlled unidirectional release. Gastro-Intestinal Muco-Adhesive Patch System (GIMAPS) is an approach for inducing greater levels of absorption and stability at the intestinal epithelium and administered as oral drug delivery system. This method involves the useof millimetersize mucoadhesive patches that adhere to the intestinal wall and direct solute diffusion towards the wall. It comprises layers of thin, flexible multi-membranes like an impermeable backing – water insoluble polymer; a drug reservoir; a rate controlling membrane and an adhesive. Formulation batches F7 and F10 showed tensile strength of 7-8Nmm2. Swelling indexofbatchF7andF10after30minswas12.52and14.28.Drugreleasefrombatch F7 and F10 after 8hrs was 76.39% and 74.82% respectively. Both the batches followed zero–order kinetics with co-relation co-efficient r2 – 0.9566 and 0.9789 respectively. Permeation study from batch F7 and F10 showed drug permeated about 59.85% and 60.12% respectively. Thus it can be claimed that the GIMAPS formulations of batch F7 and F10 are stable, efficacious and capable of releasing DLX for a period of 8 hrs.

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    Author: Shivam Yadav

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  • Title: Formulation and Evaluation of Gastro-retentive floating microballoons of Acetohydroxamic

    Abstract: Develop a drug delivery system which can provide therapeutically effective plasma drug concentration for a longer period there by reducing the dosing frequency and minimizing fluctuation in plasma drug concentration at steady state by delivering the drug in a controlled and reproducible manner. Increased gastric retention time of dosage form improves bioavailability, reduces drug waste and improves solubility of drugs which are less soluble. These dosage forms also deliver drugs locally to stomach and proximal small intestine. Microballoons(Hollow microsphere) are gastro retentive drug-delivery systems with non effervescent approach. Microballoons are empty particles of spherical shape without core. These microspheres are usually free flowing powders consisting of proteins or synthetic polymers, ideally with a size less than 200 micrometer. In the development of floating microballoons of Acetohydroxamic acid, Drug-Excipient compatibility study was conducted using DSC& FTIR and found that the drug was compatible with all the excipients used in the study. The solubility of drug was also determined in different media like 0.1 N HCl, 6.8 pH buffer, 7.4 pH buffer and distilled water. The results showed that the drug was very freely soluble indistilled water and the solubility was increased with increase in pH. The floating microballoons were prepared by solvent evaporation method using Eudragit RS 100, Eudragit S 100, HPMC K4M and Ethylcellulose as polymers. Prepared microballoons were evaluated for the following in vitro evaluation tests such as micromeritic properties, tapped density, particle size measurement, percentage yield, entrapment efficiency, In vitro buoyancy, drug content, results of all the tests were within the pharmacopoeial specifications and the microballoons remained buoyant for more than 12 hrs in 0.1NHCl. Based on the evaluation of floating and dissolution behaviour, formulation (AHF5) which showed complete release with in 12hours and superior entrapment efficiency and stability was selected as optimized formulation.

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    Author: Ravi Prakash, Surendra Pratap Singh, Jitendra Malik

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  • Title: Formulation and Characterization of Herbal Nanogel for Fungal Skin Infections

    Abstract: The present study provides a novel herbal Nano formulation for the treatment of fungal skin infections. Extraction of the medicinal plants (Pipper longum, Phyllanthus niruri and Berberis aristata) and C. lanatus seed oil was carried out. After the extraction process, the extracts were used for quantitative and qualitative assessment of Phytoconstituents, their antioxidant and anti-inflammatory potential. Moreover, the GCM Sprofiling of the oil extracted from C. After that, plant extracts nanoemulsion formulation was prepared with different biopolymers namely sodium alginate, chitosan and gum arabic. On the basis of physical evaluation, stability parameters and low droplet size, gumarabic based nanoemulsion with varying concentration of oils was selected to formulate into nanogel with two gelling agents i.e xanthan gum and guar gum. Nine different ratios of xanthan gumand guar gum were formulated with five different ratios of oils i.e (1%, 3%, 5% and 10%). After that on analyzing physical evaluation, droplet size and polydispersity index characterization. Out of total 72 ratios, 36 ratios of xanthan gum and 36 ratios of guargum it was found that 2:1:1:1 ratio of guar gumnanogel and 1:1:1:1 ratio of xanthangum nanogel showed good stability, in vitro drug release studies showed that the B. aristata guar gum based herbal nanogel showed higher drug release rate which permitted a faster rate of drug dissolution into the aqueous phase. The release kinetics fitting data indicated that drug release followed the Quasi Fickian and Fickian diffusion release model. Further, in vitro antidermatophytic activity of optimized herbal nanogel against T. rubrum and T.mentagrophytes was carried out. The results revealed that guar gum nanogel formulated with B. aristata showed significant zone of inhibition as compared to B. aristata xanthan gum nanogel and ketoconazole against T. rubrum. In vivo studies had confirmed the prepared B. aristata nanogel retarded the growth of T. rubrum. In the end stability studies was carried out indicating that the B. aristata guar gum based nanogel formulation is stable and found to be consistent with no change in drug content, pH values, phase separation, and transparency for upto 3 months. Thus, our B. aristata nanogel is a safe, effective and promising formulation for the topical treatment of dermatophytic skin infections.

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    Author: Vipul Tiwari, Surendra Pratap Singh, Jitendra Kumar Malik

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  • Title: Formulation, Development and Evaluation of Poly-herbal Formulation for Antiulcer and Antispasmodic activity

    Abstract: Formulation of Poly-herbal suspension for Antiulcer and Antispasmodic activity, were identified phytochemical and then Polyherbal suspension was prepared with the extracts of Abieswebbiana (Talispatra), Plumbago zeylanica (Chitrak), and Rubiacordiafolia (Manjistha) with a suitable suspending agent. They were taken in the ratio of 1:2:1. Suspension was prepared by trituration method in mortar and pestle by using the suitable suspending agent of Tween 80 and Sodium Carboxy Methyl Cellulose along with other excipients, The evaluation parameter was studied started with the physical test such as nature, color, odor and texture. The all the three formulations were liquid in nature and dark brown in color with pleasant odor. The physicochemical parameters of formulation studied using sedimentation volume, particle size, viscosity, pH, redispersibility, zeta potential and density, Acute toxicity study of extracts and PHF- F2 were done on basis of OECD guidelines. Results exhibited that the prepared polyherbal formulation was non-toxic to the animals. No any change in behavior, locomotor activity, color and eyes was detected in 14 days study. Thus, lower doses of formulation F2 (200 mg/kg bw) were selected for in-vivo studies on animals. The Plumbagozeylanica (400mg/kgbw) and PHF-F2. Exhibited a substantial decrease in UI as equated to that of vehicle and standard treated group while the Abieswebbianaa nd Rubiacordiafolia (400mg/kg bw) didn't exhibit any substantial effect on ulcer index. Biostatistical analysis was conducted using one-way analysis of variance (ANOVA) followed by Bonferroni’s t-test. Significant decrease (p<0.05) in all test parameters including gastric volume, pH, total acidity, free acidity, and ulcer index was observed in PHF F2 treated animals as compared to induced Control group. Histopathological examination also revealed protective potential of PHF-F2 in gastric mucosa. Based on these observations it is concluded that the PHF F2 comprises significant antiulcer activity. The finding of this experimental study helps the scientific community to further investigate this candidate medicinal plant by initiating advanced studies on formulations of plant source drugs.

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    Author: Pradeep Yadav, Surendra Pratap Singh, Jitendra Kumar Malik

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  • Title: Formulation and Development of Mycophenolic Acid loaded Nanogel for the Effective Treatment of Psoriasis

    Abstract: Formulation Development, of MPA-NLC and its therapeutic evaluation in imiquimod-induced model of psoriasis in albino mice. MPA loaded NLCs (MPA-NLCs) have been prepared using psoriasis in hot melt technique followed by homogenization and sonication. The different Excipients used for the preparation of MPA-NLC were glyceryl behenate, oleic acid, and span 80. Pareto and Box Behnken designs were used in the experiment's strategy to optimize MPA-NLCs and determine how the amount of lipid, homogenization speed, and surfactant concentration affect particle size, zeta potential, and entrapment effectiveness. A total 17 batch (F1-F17) were determined by the design of experiment and on the basis of PS, ZP and EE% batch F16 was selected as optimized batch and used for further studies. It was found that MPA-NLC exhibit nano-range particle size, narrow PDI, negative ZP, high EE% and drug loading. The morphological determination of MPA-NLC was carried out to determine the physical characteristic of MPA-NLC using SEM, TEM and AFM. It was found that MPA-NLC were spherical in shape with smooth surface, less agglomeration and uniform size distribution. Further, FTIR, XRD and DSC studies were also performed to determine the compatibility and structural change in MPA- NLC. The FTIR study showed amorphous transition and entrapment of MPA in the lipid matrix due to the presence of broad peaks in the spectra. indings indicates that the developed MPA-NLC nanogel for topical administration could be a rational strategy to attain augmented therapeutic attributes of MPA, without or having limited serious adverse effects in psoratic individuals. However, further studies are required to validate the efficacy of developed MPA- NLC nanogel in clinical subjects bearing psoriasis and related issues.

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    Author: Arvind Kumar, Surendra Pratap Singh, Jitendra Kumar Mallik

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  • Title: Formulation Optimization and Evaluation of Taste masked Azithromycin Tablets

    Abstract: The aim of the present study was to mask the bitter taste of azithromycin by ion exchange resin complexation using Tulsion-335 resin and to formulate the resinates into dispersible tablets. The objective behind the study was to investigate the effect of swelling time (X1) and stirring time (X2), on percent drug complexation and percent cumulative drug release (% CDR) of azithromycin using central composite design. the tablets were found stable after three month study as no appreciable change was Observed in the value of drug content, hardness, disintegration time, weight variation and dissolution rate. Taste masking has gained immense significance in formulation of dispersible tablets. The ion exchange resin complexation were successfully applied to prepare taste masked azithromycin dispersible tablets Thermal study FTIR and XRD studies were instrumental in the characterization and confirmed the formation of azithromycin ion exchange resin complex. From the in vitro dissolution and taste evaluation studies it was concluded that taste masking was achieved for azithromycin without affecting the release of drug. The mathematical models developed in the optimization study can be utilized to design complex with desired % complex with desired entrapment efficiency. The optimized azithromycin resin complex was further formulated into dispersible tablets. The dispersible tablets showed better release and taste profile when compared with the marketed formulation. These formulations can be further taken up for scale up

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    Author: Nirjhar Upadhyay, Surendra Pratap Singh Parihar, Jitendra Mallik

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  • Title: Formulation and Evaluation of Multiunit Particulate System of Anti-Diabetic Gliburide and Anti-Hypertensive Bepiridil Drugs

    Abstract: Aimed to create Multiple Unit Pellet Systems (MUPS) for diabetes and high blood pressure drugs, focusing on drug delivery. The MUPS included immediate-release Bepridil pellets, sustained-release Glyburide/ immediate-release Bepridil pellets, the natural polymer used in the preparation included gum ghatti, guar gum, and locust bean gum. The drugs and excipients were characterized for their identity and purity, and their compatibility was tested. The drug-loaded, immediate-release Bepridil pellets and delayed-release Glyburide pellets showed good flow properties and high drug entrapment. The sustained-release Glyburide formulation continued drug release for a full day, while the Bepridil formulation for immediate release showed quick disintegration. The optimized Bepridil immediate release pellets were chosen for their stability. The MUPS solved the challenge of dose dumping associated with conventional formulations, reducing fluctuations and reducing repeated administration. The pharmacodynamic activity of the developed MUPS was found to retain drug activity, passing stability testing as per ICH guidelines. The study demonstrates the effectiveness of multiunit particle systems (MUPS) in treating long-term illnesses like diabetes and high blood pressure. The fixed-dose combination systems, developed using multiple unit pellet systems (MUPS), are better at treating metabolic illnesses. These systems can be used to address problems with current drug delivery methods, providing patients with tailored treatment choices. The research is useful for researchers, doctors, and companies in the pharmaceutical industry, as it could lead to more successful, safer, and economical therapies.

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    Author: Kapil Dev Shukla

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  • Title: The Impact of Citral on GABAergic and Serotonergic Transmission in Haloperidol-Induced Neuroleptic and Cataleptic Effects

    Abstract: The study explores the potential neuroprotective role of citral, a monoterpenoid compound, in haloperidol-induced catalepsy, a common side effect of neuroleptic medications. Haloperidol, an antipsychotic drug, often induces extrapyramidal symptoms (EPS), including catalepsy, due to dopaminergic blockade. Citral, derived from plants like lemongrass, has been recognized for its anti-inflammatory, antioxidant, and neuroprotective properties, which may counteract these side effects. The study investigates the modulation of GABAergic and serotonergic neurotransmission by citral as a potential mechanism to reduce haloperidol-induced motor impairments.

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    Author: Prabhat Singh Bais

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