International Journal of Pharmaceutical Investigation <blockquote>International Journal of Pharmaceutical Investigation is an official publication of Phcog.Net, publishing peer-reviewed scholarly reviews, themed issues and research articles within the entire scope of the pharmaceutics. The journal particularly aims to foster the dissemination of scientific information by publishing manuscripts related to current pharmaceutical drug delivery and related fields and submission of uninvited expert reviews and research articles in all areas of pharmaceutical drug delivery are welcomed. The journal publishes the following categories of manuscripts: research papers presenting original research, reviews, short communications, letter to the editor, commentaries, etc. including critical review articles providing comprehensive analysis of research development within a defined area and editorial commentaries on key topical issues in pharmaceutical drug delivery. <br><br></blockquote> <p><strong>Subjects covered in the journal</strong></p> <p>The journal aims to cater the latest outstanding developments in the field of Pharmaceutical sciences and Technology covering the following topics (non-limiting):</p> <blockquote>· Pharmaceutics<br> · Nanotechnology<br> · Current Novel Drug Delivery Systems<br> · Quality control of Pharmaceuticals<br> · Quality Assurance<br> · National and International Regulatory Affairs<br> · Validation Techniques<br> · Industrial Pharmacy<br> · Biopharmaceutics and Drug Disposition<br> · Pharmacokinetics<br> · Drug Development<br> · Pharmaceutical Intellectual Property Rights.</blockquote> EManuscript en-US International Journal of Pharmaceutical Investigation 2230-973X Unexplored Potential of Traditional Chinese Medicine in Diabetes Mellitus <p style="text-align: justify;">Diabetes is one of the most prevalent disease worldwide and is associated with one of the highest morbidities and mortality rates associated. Like the western and conventional medicines, Traditional Chinese medicine (TCM) has promising results in the ailment of diabetes and its associated complications. But still the use of TCM is refrained for further explorations due to inadequate knowledge of active pharmaceutical ingredient and its isolation. Thus, this review will highlight some of the key concepts and rational behind the therapeutic regimen of TCM aiming towards diabetes treatment. A detailed study of all the articles including research as well as reviews, which were available on the world wide web was performed. The review includes MEDLINE and EMBASE databases using keywords alone or in combinations, such as diabetes, diabetic complications, Chinese therapy, traditional chinese medicine, diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, diabetic complications, α-amylase and several others. TCM collectively is an effective and comparatively safe in the treatment of diabetes mellitus and its associated complications. Significant results are seen in monotherapy and in combination therapy with current conventional drugs. The effects include controlling glycemic levels along with the mitigation of diabetes associated complications. Focus on clinical trials and further investigations might help in concluding TCM as one of the most effective and safe treatment therapies. TCM holds enormous potential by virtue of its mechanism of action by maintaining the homeostasis in the body and thereby exhibiting pharmacological action.</p> Amit Gupta Tapan Behl Arun Kumar Sukhbir Singh Shaveta Bhardwaj Amit Goyal ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 1 7 10.5530/ijpi.2020.1.1 3D Printing in Pharmaceutical Technology – A Review <p style="text-align: justify;">Three-dimensional printing is a revolutionary technique that uses computer aided design software and programming to create three dimensional objects by placing material on a substrate. 3D printing is an additive layer manufacturing techniques, where consecutive layers of material are deposited or solidified to form a 3D structure. Medicinal substances is configured in three dimensional with computer assisted design module and transformed to a machine legible form which suggests the exterior emerge of the 3D dose form, then it sliced this surface into number of different printable coats and convey these layers to the machine. The different 3D printing techniques has been developing and developed to fabricate novel solid dosage forms, which are among the most well-known and discrete products today. The 3D printing process desires to be espoused by pharmaceutical sector and capable of exploring the marvels fetched by the approach. 3D printing can include a very new possibilities to optimized medicine. The current review is an effort of briefing various methods (Thermal Ink jet printing, Ink jet printing, Fused deposition modeling, Extrusion 3D Printing, Zip dose, Hot melt extrusion, 3D printer, Stereolithography, Selective laser sintering, Laser-Based Writing System, Continuous Layer Interface Production, Powder Based 3D Printing), advantages, limitations, applications of 3D printing in pharmaceutical technology.</p> Ravikumar Tamil Ponni Mahalingam Swamivelmanickam Sivagnanam Sivakrishnan ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 8 12 10.5530/ijpi.2020.1.2 Pharmacognostic and Phytochemical Characteristics of the Fruits of Bunium persicum (Boiss.) B. Fedtsch, Growing Wild in Kashmir Valley, India <p><strong>Introduction:</strong> <em>Bunium persicum</em> (Boiss.) B. Fedtsch belongs to family&nbsp;<em>Apiaceae</em> of genus <em>Bunium</em>, which is comprised of about 166 species and&nbsp;is widely distributed in Kashmir valley. It is used medicinally in dyspepsia&nbsp;and diarrhea, digestive and urinay tract infections, chronic gastiritis, colitis,&nbsp;anticonvulsant, antiasthma and diuretic. <strong>Objectives:</strong> The current study&nbsp;deals with Pharmacognostic parameters of the fruits of <em>Bunium persicum&nbsp;</em>(Boiss.) B. Fedtsch. <strong>Materials and Methods:</strong> The fruits of<em> Bunium persicum</em>&nbsp;(Boiss.) B. Fedtsch was collected, shade dried for about 2 weeks&nbsp;and powdered and the powered fruit part of plant material was evaluated&nbsp;for Pharmacognostic parameters by standard methods. The hydroalcholic&nbsp;extract of <em>Bunium persicum</em> was subjected to preliminary phytochemical&nbsp;screening for the presence of various Phytoconstituents. The microscopy&nbsp;of the fruits of<em> Bunium persicum</em> (Boiss.) B. Fedtsch reveals the presence&nbsp;of Part of a group of sclereids from the mesocarp, thicker-walled sclereids&nbsp;with adjacent thin walled parenchyma, Fragment of vitta, Thin-walled&nbsp;fibre and Calcium-oxalate crystals. <strong>Results:</strong> Proximate analysis of the fruits&nbsp;of <em>Bunium persicum</em> (Boiss.) B. Fedtsch showed that the dried fruit powder&nbsp;has 34.0 % Total ash value, 29.0 % Acid insoluble ash value, 9.5 %&nbsp;Sulphated ash value. Loss on drying was found to be 6.2 %. The hydroalcholic&nbsp;extract of <em>Bunium persicum</em> was found to contain various phytoconstituents.&nbsp;Fluorescence analysis of the fruit powder showed the behavour,&nbsp;when treated with different chemical reagents. <strong>Conclusion:</strong> The current&nbsp;study displayed the microscopical characters, the preliminary phytochemical&nbsp;screening and the <em>proximate</em> analysis of the fruits of <em>Bunium persicum</em>&nbsp;(Boiss.) B. Fedtsch. Data composed from such studies can be used as standard&nbsp;in the quality control of this plant as a herbal medicine for treatment&nbsp;of various diseases.</p> Riehana Gani Zulfiqar Ali Bhat Mudasir Ahmad Dar Mohammad Akbar Dar Junaid ul Yousuf Rather ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 13 16 10.5530/ijpi.2020.1.3 Gas Chromatography Analysis of Diallyl Disulphide and Diallyl Trisulphide and Antioxidant Activity in Black Garlic <p><strong>Background:</strong> Diallyl disulphide (DADS) and diallyl trisulphide (DATS) found&nbsp;in garlic provide biological activity which protects against oxidative damage.&nbsp;This study aimed to confirm the presence of DADS and DATS compounds&nbsp;in black garlic, formed from heads of fresh garlic through a process of heating&nbsp;and fermentation. <strong>Methods:</strong> Analysis was performed using Shimadzu&nbsp;GC-17A gas chromatography with DB-5 column and flame ionisation detector&nbsp;at column temperatures of 140°C with programmed temperature rises&nbsp;of 1°C/min to 180°C, injector and detector temperatures of 200°C and 0.8&nbsp;mL/min flow rate. Antioxidant activity were tested against the stable DPPH&nbsp;(2,2‐diphenyl‐1‐picryl‐hydrazyl‐hydrate) free‐radical. The ability to scavenge&nbsp;DPPH radical was measured in these experiments by the discoloration of&nbsp;the solution. <strong>Results:</strong> The validation results showed that the coefficients&nbsp;of correlation (r) for DADS and DATS are 0.9999 in the range of 0.1–10&nbsp;μg/mL. The values limit of detection and limit of quantitation were 0.0096&nbsp;and 0.0210 μg/mL for DADS compounds and 0.0198 and 0.0662 μg/mL for&nbsp;DATS compounds. Extraction using ethyl acetate produced average content&nbsp;of DADS and DATS of 0.0012 and 0.0009%, respectively. <strong>Conclusion:</strong>&nbsp;Among heating at 80°C and humidity of 75% for three months, it was&nbsp;shown that there were decreasing levels of these compounds during the&nbsp;ageing process from fresh garlic to black garlic and the shorter time are&nbsp;those that generally have a higher antioxidant activity.</p> Harmita Harmita Herman Suryadi Mohdar Syarif Lidwina Deviani Liksasa ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 17 23 10.5530/ijpi.2020.1.4 Chebulinic Acid Negated the Development of Streptozotocin- Induced Experimental Dementia in Rats <p>Chebulinic acid (ChA) has been reported to possess neuroprotective potential in various neurodegenerative models such as anxiety and depression. In the current study, the ChA was challenged against intracerebroventricular (ICV)-streptozotocin (STZ)-induced neurotoxicity to determine its therapeutic potential in dementia. STZ was infused bilaterally (3 mg/kg/icv) on day 1<sup>st</sup> and 3<sup>rd</sup> after surgery. ChA (25, 50 and 100 mg/kg/p.o) was administered from 7<sup>th</sup> day onwards up to 21<sup>st</sup> day following 1<sup>st</sup> ICV-STZ infusion. Spatial and non-spatial memory was evaluated and terminally the animals were sacrificed and hipoocampal brain regions were used to identify biochemical and histopathologicsal alterations. Ventricular administration of STZ in rats caused impairment in learning and memory indicating cognitive dysfunctions. The observed cognitive dysfunctions was also associated with significant alterations in hippocampal biochemistry, including elevation in oxidative stress, found to significantly shorten the latency time on the MWM and ORT which was associated with increase in oxidative stress (lipid peroxidation and nitrite), compromised antioxidant defense (reduced glutathione), neurotransmitter alteration (AChE, dopamine, noradrenaline, 5-hydoxytryptamine, Gama amino butyric acid and glutamate) and elevation in neuroinflammatory cytokine (IL-1 β, IL-6 and TNF- α) levels. The number of apoptotic neurons was increased in hippocampus tissue after ICV-STZ administration. The histopathological studies in the brain of rats also supported that ChA markedly reduced the ICV-STZ-induced histopathological changes and well preserved the normal histological architecture of the hippocampus. The study demonstrates the effectiveness of ChA, as a powerful antioxidant, anti-inflammatory and neuromodulatory in preventing the all these detrimental effects induced by STZ. ChA treatment significantly prevented the ICV-STZ-induced memory deficit by attenuating the hippocampal neuronal loss, neuroinflammation and compromised antioxidant defense and cholinergic deficit in rats. Thus, ChA may have a therapeutic value for the treatment of AD.</p> Arora Rimpi Deshmukh Rahul ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 24 31 10.5530/ijpi.2020.1.5 Ameliorative Effect of Salvadora persica (Miswak) on Cigarette Smoke Induced Anxiety and Depression in Rats <p><strong>Objectives:</strong> The aim of the study is to evaluate the anxiolytic and antidepressant&nbsp;activity of<em> Salvadora persica</em> in cigarette smoke-induced neurobehavior&nbsp;changes in rats. <strong>Methods:</strong> The lyophilized decoction of <em>Salvadora</em><br><em>persica</em> (<em>S. persica</em>) was administered daily for four weeks by oral route at&nbsp;the doses 50, 100 and 200 mg/kg to the cigarette smoke exposed rats. The&nbsp;depression and anxiety studies were done by forced swim test and elevated&nbsp;plus maze test, respectively. The serum levels of monoamine oxidase-A&nbsp;and relative brain weight were also determined. The results were analyzed&nbsp;statistically by one-way ANOVA followed by Duncans’ multiple range tests.&nbsp;<em>p</em>&lt;0.05 was considered to indicate the significance of results. <strong>Results:</strong> The&nbsp;observation from the study indicated that exposure of cigarette smoke for&nbsp;eight weeks significantly (<em>p</em>&lt;0.01) enhanced the experimental parameters&nbsp;of depression and anxiety, besides increasing the monoamine oxidase-A&nbsp;and relative brain weight when compared with control animals. Administration&nbsp;of <em>S. persica</em> exhibited a dose-dependent inhibition in the neurobehavioral&nbsp;parameters. <em>S. persica</em> at 200 mg/kg produced significant (<em>p</em>&lt;0.01)&nbsp;antidepressant and antianxiety effects. The treatment was also found to&nbsp;reduce the serum monoamine oxidase-A and relative brain weight in the&nbsp;cigarette smoked animals.<strong> Conclusion:</strong> The data suggests that decoction&nbsp;of <em>S. persica</em> might possess antidepressant and anxiolytic properties in the&nbsp;cigarette smoke exposed animals. These actions could be related to its&nbsp;antioxidant and reversal in the neurocircuilatory changes induced by the&nbsp;cigarette smoke.</p> Syed Imam Rabbani ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 32 36 10.5530/ijpi.2020.1.6 Comparative Pulmonary Protective Efficacy of Amifostine and it’s Analogue S-2(2-aminoethylamino)ethyl Phenyl Sulfide (DRDE-07) against Sulphur Mustard Induced Oxidative Stress and Inflammation in Female Mice <p><strong>Aim:</strong> The present study was undertaken to investigate the comparative pulmonary&nbsp;protective efficacy of Amifostine (S-2[3-aminoprophylamino] ethyl&nbsp;phosphorothioate) and its analogues DRDE-07 (S-2(2-aminoethylamino)&nbsp;ethyl phenyl sulfide) against sulfur mustard toxicity in mice. <strong>Materials and&nbsp;Methods:</strong> Twenty female mice were divided into four groups: Control, SM&nbsp;group animals were percutaneously exposed to 16.2 mg/kg. The third and&nbsp;fourth group of animals received amifostine and DRDE-07 (210 and 250&nbsp;mg/kg&nbsp; respectively) through the oral route, 30 min before SM exposure.&nbsp;The clinical symptoms and body weight changes were observed daily and&nbsp;sacrificed on 7<sup>th</sup> day. Bronchoalveolar lavage fluid (BALF) and lung tissue<br>were collected for biochemical and histopathological studies. The following&nbsp;biochemical endpoints were studied in BALF (total cell count, lactate&nbsp;dehydrogenase, protein content, β-glucuronidase activity, MMP-2, 9 activity<br>and FSH) whereas reactive oxygen species (ROS), reduced glutathione&nbsp;(GSH), lipid peroxidation, superoxide dismutase, catalase and myeloperoxidase&nbsp;activity was measured in lung tissue. The above biochemical observations&nbsp;are also supported by histopathology studies. <strong>Results:</strong> Dermal&nbsp;exposure to SM significantly reduced body weight. The significant increase&nbsp;in BALF LDH leakage, protein content, cell number and MMPs activity in&nbsp;the SM exposed animals suggest disruption of endothelial barrier in the&nbsp;lung (<em>p</em>&lt;0.05). Significant ROS generation (<em>p</em>&lt;0.05) was observed in lung&nbsp;tissue of SM group which results in a significant decrease in SOD GSH<br>and CAT and an increase in MDA (<em>p</em>&lt;0.05). These alterations in BALF as&nbsp;well in lung tissue due to SM exposure was significantly prevented by the&nbsp;pretreatment of amifostine and DRDE-07 (<em>p</em>&lt;0.05). The histopathological&nbsp;observations also support the above results. The above results indicate that&nbsp;the preventive efficacy of DRDE-07 is better than amifostine. <strong>Conclusion:&nbsp;</strong>The percutaneous SM exposure-induced pulmonary damages were significantly&nbsp;protected by DRDE-07 than amifostine in mice.</p> Alok Kumar Soni Uma Pathak Durga Prasad Nagar Arvind Kumar Gupta Gurusamy Mathu Kannan ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 37 42 10.5530/ijpi.2020.1.7 Development of Sheep Butter Based Cream for Dermal Wound Healing <p><strong>Objectives:</strong> Sheep butter has been traditionally used in the local villages of&nbsp;upper Himalayan region for its various dermatological benefits. In the current&nbsp;study, sheep butter cream was formulated and evaluated for its wound&nbsp;healing properties for the purpose of scientific validation, standardization,&nbsp;safety, efficacy evaluation. <strong>Methods:</strong> Nine formulations were developed&nbsp;with varying concentrations of ingredients and evaluated for different parameters.&nbsp;Optimized formulations showing neutral pH, good homogeneity&nbsp;and texture, viscosity, spreadability, consistency and antibacterial activity&nbsp;were selected for evaluation of wound healing property in excision wound&nbsp;model and were compared to standard marketed product. <strong>Results:</strong> From&nbsp;the results obtained, it was observed that formulated creams enabled easy&nbsp;application and removal from the skin without any evidence of irritation,&nbsp;erythema or leftover residue. Amongst all formulations, F-11, F-12 and F-13&nbsp;showed the most satisfactory properties and were studied in details. Formulations&nbsp;F-12 and F-13 containing 7.5 g and 10g sheep butter respectively&nbsp;were chosen for evaluation of wound healing activity in excision wound&nbsp;model in albino rats. It was noted that on the 15<sup>th</sup> post-wounding day, F-12 and F-13 showed 94.4±0.3% and 96.9±0.6% wound contraction respectively,&nbsp;which were found to be significantly higher when compared with the&nbsp;wound contraction of control group (79.3±7.5%) and was comparable with&nbsp;the standard group. <strong>Conclusion:</strong> Thus sheep butter appears to be effective&nbsp;agent in the management of wound healing activities.&nbsp;</p> Rai Pratikcha Das Sujit Ghosh Tanmoy Deveswaran Rajamanickam Mohanta Tanmay Roy Kalyan ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 43 48 10.5530/ijpi.2020.1.8 Probilosomes: A Novel Bile Salt Containing Nanocarrier for Enhancing Oral Bioavailability <p><strong>Objective:</strong> Probilosomes vesicular drug delivery system was developed to&nbsp;prevent acid degradation of the drug and to improve its oral bioavailability&nbsp;by resisting the drug release in acidic pH of the stomach. <strong>Method:</strong> Thin-film&nbsp;hydration technique was adopted to prepare probilosomes using soybean&nbsp;phosphatidylcholine (lipoid S100) bile salt (Sodium Deoxycholate) and mannitol&nbsp;as a carrier. The formulations were optimized using (3<sup>2</sup>) general full&nbsp;factorial design. <strong>Results:</strong> The prepared probilosomal formulations were&nbsp;evaluated for entrapment efficiency, drug content and <em>in vitro</em> dissolution&nbsp;studies. Based on the entrapment efficiency values and sustained drug&nbsp;release (PB9) formulation is optimized and further evaluated for surface&nbsp;morphology (SEM), particle size, polydispersity index, zeta potential and&nbsp;<em>ex vivo</em> studies. The optimized formulation (PB 9) showed particle size,&nbsp;polydispersity index (PDI) of 76.4 nm, 0.45 and zeta potential of -9.17 mV&nbsp;respectively. <em>In vitro</em> dissolution studies showed less than 20% of drug&nbsp;release at pH 1.2 and sustained release in pH 6.8 phosphate buffer up to 8&nbsp;hr. The <em>ex vivo</em> studies indicated a 2 fold increase in the oral bioavailability&nbsp;of the probilosomal formulation compared to pure drug. <strong>Conclusion:</strong> Rosuvastatin&nbsp;calcium probilosomes were successfully prepared to resist the&nbsp;drug release in stomach pH and prevent the acid degradation of the drug.&nbsp;<em>Ex vivo</em> studies showed increased oral bioavailability of the probilosomal&nbsp;formulations compared to pure drug. Hence, these formulations can be&nbsp;used as an alternative to conventional enteric dosage forms.</p> Haritha P Lakshmi PK ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 49 53 10.5530/ijpi.2020.1.9 Preparation and Characterisation of Sustained Released Dosage Form for Ketoprofen using Natural Gums <p><strong>Objective:</strong> The major objective of this work is to formulate a sustained&nbsp;launch matrix drugs the use of cashew and neem gum. Ketoprofen turned&nbsp;into decided on as a version drug because of the low half-life. Hence<br>sustained dosage forms are formulated to lessen the dosage frequency.&nbsp;<strong>Methods:</strong> Ketoprofen matrix tablets were formulated by employing cashew&nbsp;gum and neem gum as a release rate retardant material and used in<br>10%, 20%, 30% and 40% Concentration levels. Wet granulation method&nbsp;was used to develop sustained release tablets. Tablet was evaluated in&nbsp;terms of flow properties of blended powders and the average weight, drug<br>content hardness, <em>in vitro</em> dissolution studies and fourier transformationinfrared&nbsp;spectroscopyn (FT-IR) were determined. Drug release was evaluated&nbsp;with zero and the first order for release kinetics, Higuchi, Korsmeyer<br>peppas models for the release mechanism.<strong> Results:</strong> The hardness of the&nbsp;tablets ranged from 5.5 to 6.8 Kg/cm<sup>2</sup> and the friability values were less&nbsp;than 1% indicating that the matrix tablets were compact and hard. All the<br>formulations satisfied the content of the drug as they contained 99.1 to&nbsp;100.8 % of ketoprofen, KCS8 released 99.2 of drug in 12 hrs and considered&nbsp;as optimized formulas. KCS8 formulation has shown drug release by<br>zero order kinetics. This data reveals that drug release follows fickian diffusion&nbsp;mechanism Peppas model. <strong>Conclusion:</strong> The present study could&nbsp;establish the suitability of neem gum, cashew gum as Controlled released<br>(CR) polymer in the design of matrix tablets.</p> Srinivasa Rao Baratam Made Vijay Harsha ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 54 58 10.5530/ijpi.2020.1.10 Cross-Linked Chitosan Based Stomach Specific Mucoadhesive Microspheres Loaded with Amoxicillin: Preparation and ex vivo Characterization <p><strong>Objectives:</strong> This research was aimed to evaluate a novel approach for&nbsp;preparation of mucoadhesive microspheres which can reside in the gastrointestinal&nbsp;tract for an extended time period. The microspheres contained&nbsp;amoxicillin, an anti-bacterial agent useful for the eradication of Helicobacter&nbsp;pylori. <strong>Methods:</strong> Ten different formulations were prepared by chemical&nbsp;cross-linking technique using gluteraldehyde as a cross linking agent and&nbsp;chitosan as mucoadhesive polymer. Natural release retardant polymers like&nbsp;guar gum, gum ghatti and xanthan gum were employed. All the microspheres&nbsp;were characterized for morphology, particle size, drug entrapment&nbsp;efficiency, swelling index, bioadhesion to mucosal tissue and in vitro drug&nbsp;dissolution and anti-bacterial activity against <em>E. coli</em>. <strong>Results:</strong> The FTIR and&nbsp;DSC data indicated that there were no interactions between the drug and&nbsp;polymers used. All the microspheres exhibited good flow properties. The&nbsp;microspheres had a spherical shape with rough surface. The microspheres&nbsp;showed a good mucoadhesivity and also anti-bacterial activity. The release&nbsp;of the drug was prolonged to 12h when incorporated into mucoadhesive<br>microspheres. <strong>Conclusion:</strong> Data obtained in this study concluded that mucoadhesive&nbsp;microspheres of amoxicillin can be used to effectively clear<em>&nbsp;H. pylori</em> from the gastrointestinal tract due to prolonged residence time&nbsp;resulting from mucoadhesion. In this study drug release was diffusion controlled&nbsp;and followed zero order kinetics.&nbsp;</p> Radha Rani Earle Vanthala Vijaya Bharathi Ayalasomayajula Lakshmi Usha Andhavarapu Venkata Srinivasa Ksheera Bhavani ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 59 63 10.5530/ijpi.2020.1.11 Limonene-based Self-nanoemulsifying System: Formulation, Physicochemical Characterization and Stability <p><strong>Objectives:</strong> The aim of current research was to formulate limonene selfnanoemulsified&nbsp;delivery system (SNEDS) by spontaneous emulsification&nbsp;&nbsp;method. <strong>Methods:</strong> The optimization was carried out through the construction&nbsp;of a pseudo-ternary phase diagram. Limonene-based self- nanoemulsifying&nbsp;system was optimized by evaluating its droplet characteristic;&nbsp;namely; size, polydispersity, zeta potential, in addition, its morphology was&nbsp;assessed through the use of transmission electron microscopy. Moreover,&nbsp;the formulation stability under different storage conditions for three&nbsp;months was examined. <strong>Results:</strong> The obtained results showed that the&nbsp;optimized limonene-based self-nanoemulsifying system was characterized&nbsp;by a small droplet size, low polydispersity index, high percentage transmittance&nbsp;and optimal zeta potential with uniform spherical droplets. The&nbsp;selected formulation with 50% w/w limonene, 40% w/w Tween 80 and&nbsp;10% w/w propylene glycol had a droplet size of 113.3±1.18nm with bluish&nbsp;transparent appearance and a zeta potential value of -19.13±0.38 mV. The&nbsp;developed formula was stable against pH change. The stored limonenebased&nbsp;SNEDS showed acceptable stability at 4°C and 0°C compared to&nbsp;25°C. <strong>Conclusion:</strong> The formulated self-nanoemulsifying system showed&nbsp;an improved aqueous dispersibility, patient acceptability and stability of&nbsp;limonene, representing a promising carrier for lipophilic drugs.</p> Mohammed Maher Mehanna ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 64 69 10.5530/ijpi.2020.1.12 Determination of Irbesartan Using Stability Indicating Reverse Phase Liquid Chromatographic and UV Spectrophotometric Method <p><strong>Objectives:</strong> The present research work involve the development of a novel&nbsp;UV-Spectrophotometric and stability-indicating RP-HPLC methods for the&nbsp;irbesartan in bulk as well as tablet dosage form. <strong>Methods:</strong> The RP-HPLC&nbsp;method is performed on the Phenomenex C<sub>18</sub> column (150 x 4.6 mm,&nbsp;5 μm) particle size, using 0.1% Formic acid buffer (pH 3.2): Acetonitrile&nbsp;(60:40 v/v) as the mobile phase at a flow rate of 1.0 mL/min at the 220 nm&nbsp;detection wavelength. For the UV method the 0.1% formic acid was used&nbsp;as solvent. Validation study was performed for both the methods as per&nbsp;ICH guidelines. <strong>Results:</strong> A linear range of 1.5-120 μg/mL for HPLC and 1.75-110.5 μg/mL for UV method was obtained with a correlation coefficient of&nbsp;0.998 for UV and 0.999 for HPLC method. The retention time of irbesartan&nbsp;was found 2.226 min using optimised condition. In force degradation&nbsp;study the acidic and alkaline conditions decomposes the irbesartan more&nbsp;in compared to other stressed conditions. In UV method the measurement&nbsp;of the absorbance of Irbesartan at λ<sub>max</sub> equals to 220 nm. The developed&nbsp;UV and HPLC methods was found suitable to assay the marketed tablet&nbsp;dosage form with the percentage purity values of 95.78% and 96.68%. All&nbsp;the other validation parameters were found within the limit that has been&nbsp;conducted as per the ICH guidelines. <strong>Conclusion:</strong> The developed methods&nbsp;were found novel, reliable and easy for the estimation of irbesartan in bulk&nbsp;and tablet dosage form.</p> Sumanta Mondal Arindam Pal Prasenjit Mondal Dipankar Shit Sabyasachi Biswal Beemarasetti Mohan Babu ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 70 75 10.5530/ijpi.2020.1.13 Separation and Simultaneous Quantitation of Montelukast Sodium and Ebastine in Tablets by using Stability-Indicating Liquid Chromatographic Method <p><strong>Objectives:</strong> A precise, accurate and selective stability-indicating reverse&nbsp;phase high performance liquid chromatographic assay method has been&nbsp;developed for the simultaneous quantitative determination of Montelukast&nbsp;sodium and Ebastine in tablets.<strong> Methods:</strong> The chromatographic separation&nbsp;of drugs was attained by using Hypersil octadecyl silane C<sub>18</sub> (250 x 4.6&nbsp;mm, 5μm) column at room temperature. The composition of mobile phase&nbsp;was methanol, acetonitrile and 0.02M ammonium acetate buffer (pH 5.5&nbsp;adjusted with dilute acetic acid) in the ratio of 80:15:05 v/v/v and flow rate&nbsp;of mobile phase 1.0 ml/min with isocratic elution. The signal of eluents&nbsp;was observed at 244 nm by using diode array detector. <strong>Results:</strong> The retention&nbsp;time of Montelukast sodium and Ebastine were found to be 4.28 min&nbsp;and 6.63 min, respectively. The linearity ranges for both drugs were found&nbsp;to be 10-50 μg/ml and the percent recoveries were found to be 99.16%&nbsp;and 100.12% for Montelukast sodium and Ebastine respectively. The drug&nbsp;substances and drug products were treated with various forced degradation&nbsp;conditions like acid hydrolysis, alkali hydrolysis, oxidative degradation,&nbsp;thermal degradation and photolytic degradation. The degradants were efficiently&nbsp;separated from the drugs by using optimized chromatographic conditions.&nbsp;The developed method was validated as per recommendation parameters&nbsp;of International conference on harmonization guidelines Q2(R1).&nbsp;<strong>Conclusion:</strong> The validation parameters indicate that the drug substances&nbsp;were efficiently separated from its degradants and developed method can&nbsp;be routinely applied for the simultaneous quantitative determination of&nbsp;Montelukast sodium and Ebastine in combined tablet formulation in the&nbsp;quality control laboratory.</p> Shailesh Koradia Priyal Patel Ashok Mahajan Falgun Mehta Vishwa Chauhan ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 76 81 10.5530/ijpi.2020.1.14 Electrospun Fibrous Mat of Cellulose Acetate: Influence of Solvent System (Acetic Acid/Acetone) on Fibers Morphology <p><strong>Objectives:</strong> Electrospun Cellulose Acetate (CA) fibers system are of high&nbsp;demand due to its desired properties associated with the final fiber features.&nbsp;This polymer inability to dissolve may hinder its electrospinning<br>processing. The goal of the current study is to explore the fiber forming&nbsp;ability of solvent mixture of varying ratios of acetone and acetic acid and&nbsp;to derive the optimized formulation that facilitate the continuous and uniform&nbsp;CA fiber formation.<strong> Methods:</strong> In this study, a new solvent system&nbsp;for electrospinning of cellulose acetate is developed for the preparation of&nbsp;continuous uniform CA fibers. Different concentrations of cellulose acetate&nbsp;are dissolved in solvent system consisting of acetic acid/acetone mixture.&nbsp;The polymer solution prepared was hosted in a mechanical syringe pump,&nbsp;with a stainless-steel blunt end needle fixated to the tip acting as the spraying&nbsp;nozzle. The polymeric cellulose acetate in acetone/acetic acid mixture&nbsp;was examined for its viscosity and electrical conductance. Moreover, the&nbsp;formed cellulose acetate-based fibers were&nbsp; morphologically examined.&nbsp;<strong>Results:</strong> The solvent system composition as well as the cellulose acetate<br>concentration affected the final CA fiber morphology, where the 10%&nbsp;cellulose acetate solution in acetone: acetic acid at 9:1 ratio presented&nbsp;uniform fiber morphology with a diameter of 549±45 nm. The solvent system<br>optimized preserved continuous and uniform, beads-free CA fibers.&nbsp;<strong>Conclusion:</strong> In the current study, the different solvent systems studied&nbsp;presented different fiber morphologies and diameter sizes thus preserving<br>the importance of the solvent system for the cellulose acetate fine fiber&nbsp;production.</p> Mohammed Maher Mehanna ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 82 85 10.5530/ijpi.2020.1.15 Pharmacognostic Evaluation of Fruits and Leaves of Annona muricata L <p><strong>Objectives:</strong> Adulteration in marketed samples has been considered as huge draw-back in fortifying quality herbal products. The study was to investigate and establish leaves, fresh fruit and dry powdered material of pulp, for pharmacognostic standardization parameters as per WHO guideline. <strong>Methods:</strong> Extracts of <em>Annona muricata</em> (hydroalcoholic and ethyl acetate) were prepared and subjected to preliminary phytochemical screening. Further, the extracts were used to analyse total phenol and flavonoid contents and also estimated antioxidant activities using DPPH and nitric oxide assay. <strong>Results:</strong> Shape size, color, odour and surface characteristics were noted for fresh fruit. Microscopic images of leaf and powdered fruit exhibited useful diagnostic features. The stomata identified were anamocytic. Vein-islet and vein termination number of leaves of <em>Annona muricata</em> were estimated and reported. Total ash, water soluble and acid insoluble ash was found to be 22.516±1.854%, 7.671±0.730% and 11.233±1.742% respectively. Loss on drying of dry and fresh fruit was found to be 20.16% and 78.95%. The water and alcoholic extractive values were 34.4% and 18.6%. Phytochemical screening revealed the presence of phenols and flavonoids and total flavonoid and phenol content in hydroalcoholic and ethyl acetate extracts of AM and were found to be 240 mg rut/g, 102.0 mg rut/g 12.0408 mg GAE/g and, 113.74 mg GAE/g respectively. IC<sub>50</sub> values of DPPH and nitric oxide assay of hydroalcoholic extracts and ethyl acetate were estimated as 24.557 <em>μ</em>g/ml, 16.847 <em>μ</em>g/ml, 25.883 μg/ml and 23.411 <em>μ</em>g/ml respectively. <strong>Conclusion:</strong> The findings obtained from the present study helps to authenticate and establish the pharmacopeia standards for AM plant and demonstrated the antioxidant activity of fruit.</p> Swapna Birendra Harisha Ramappa Satvik Kotha Raghavendra Rao M Ramachandra Setty Siddamsetty ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 86 92 10.5530/10.5530/ijpi.2020.1.16 Development of Spray-Dried Sildenafil Citrate -α-cyclodextrin Complexes for Use in Dry Powder Inhalers <p><strong>Background:</strong> Sildenafil citrate is a drug used in the treatment of pulmonary&nbsp;hypertension. The development of sildenafil citrate complexed with&nbsp;α-cyclodextrin as dry powder inhaler (DPI) should enhance its solubility in&nbsp;the lung. <strong>Methods:</strong> Sildenafil citrate was dissolved with α-cyclodextrin solution&nbsp;at pH 4.5 to obtain inclusion complexes. The complex solution was&nbsp;spray-dried to make spheroidal powder. The sildenafil DPI formulations&nbsp;were mixed with coarse lactose and fine lactose as carriers and then filled&nbsp;in capsule no. 2. Three different ratios of course to fine lactose were used&nbsp;(1:1 (#1), 2:1 (#2) and 3:1 (#3)) to optimize the performance and aerosol&nbsp;properties. The fine particle fraction (FPF), mass median aerodynamic diameter&nbsp;(MMAD) and geometric standard deviation (GSD) were used to&nbsp;evaluate the in vitro drug delivery performance in the lung by <em>in vitro</em>.&nbsp;<strong>Results:</strong> The proportion of sildenafil in formulations #1, #2, #3 was 100.2%&nbsp;± 0.1%, 100.1% ± 0.2% and 8.9% ± 0.1%, respectively. The aerosol&nbsp;properties of the best formulation (#2) were as follows: an ED of 85.5±0.5%, an FPF of 56.6 ± 2.3%, an MMAD of 3.2 ± 0.6 μm and a GSD&nbsp;of 1.02 ± 0.01. <strong>Conclusion:</strong> Sildenafil citrate complexed with α-cyclodextrin&nbsp;was successfully developed for a DPI by using coarse and fine lactose&nbsp;monohydrate in a 2:1 ratio.&nbsp;</p> Apichart Atipairin Somchai Sawatdee ##submission.copyrightStatement## 2020-03-12 2020-03-12 10 1 93 95 10.5530/ijpi.2020.1.17