International Journal of

Drug Delivery Technology

ISSN: 0975 4415

Peer Review Journal

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1. Gastroretentive Microspheres: An Innovative Approach for Prolonging Gastric Residence
Satyajit Panda, K Priyanka, R Varaprasad, Snigdha Pattnaik
Gastro-retentive drug delivery systems (GRDDS) like gastro-retentive microspheres have gained immense popularity in the field of oral drug delivery. It is a widely employed approach to retain the dosage form in the stomach for an extended period of time and release the drug slowly that can address many challenges associated with conventional oral delivery, including poor bioavailability. Different innovative approaches like magnetic field assisted gastro-retention, swelling systems, mucoadhesion techniques, floating systems with or without effervescence are being applied to fabricate gastro-retentive microspheres. Apart from in-vitro characterization, successful gastro-retentive microspheres development demands well designed in-vivo study to establish enhanced gastro-retention and prolonged drug release. Gama scintigraphy and MRI are popular techniques to evaluate in-vivo gastric residence time. However, checking of their overall in-vivo efficacy still remains a major challenge for this kind of dosage form, especially in small animals like mice or rat. Reported in-vivo studies with beagle dogs, rabbits, and human subjects are only a handful in spite of a large number of encouraging in-vitro results. In spite of the many advantages, high subject variations in gastrointestinal physiological condition, effect of food, and variable rate of gastric emptying time are the challenges that limit the availability of gastro-retentive microspheres in the market.

2. Determination of Acceptable Residual Limit by Using Newly Developed and Validated RP-HPLC Method for Citalopram Hydrobromide Residues that Swabbed from Surfaces of Pharmaceutical Manufacturing Equipment
Indu Bala, Surajpal Verma, Anzarul Haque, Bhupinder Singh
In this study, easy and robust RP-HPLC method was developed and validated to determine acceptable residual limit of citalopram hydrobromide for cleaning procedures. The United States, Food and Drug Administration has mentioned that the acceptable limit for residues present in the equipment during processing or manufacturing should be based on logical criteria. In present study, acceptable residual limit for cleaning procedure of citalopram hydrobromide was calculated by using three approaches including therapeutic dose method, 10 ppm criteria and visual limit of inspection. The value by therapeutic dose approach was less among three calculated values hence, selected as acceptable residual limit (10.66 µg/25 cm2) for analytical method development and validation for the detection of this drug residues on the surfaces of manufacturing equipment. A RP-HPLC assay method was developed using C18 column and mobile phase containing mixture of methanol and ammonium acetate buffer (pH4.6) (70:30) with flow rate of 1.6 ml/min. System suitability parameters like theoretical plates and tailing factor were calculated for the validation of the developed method as per ICH Q2B guidelines. After analyzing recovery study data, it was found that stainless steel plate has minimum recovery (88.87%) and pre-analyzed tablet solution has maximum recovery (99.29%).

3. Technological Advancements in Oral Films
B Pandey, A B Khan
The aim of the review was to explore the necessity, advantages and different techniques of oral films for enhancing solubility of poorly soluble drugs with an emphasis on the newer, state-of the art technologies, such as 3D printing and hot-melt extrusion (HME). The historical background of oral films is presented along with the regularly used techniques. The modern approach of quality-by-design (QbD) is unravelled, identifying appropriate critical process parameters (CPP) and applied to oral films. A section is devoted modern technologies such as 3D printing and HME of oral films. Oral films are innovative formulations by which poorly soluble drugs have been founds to give positive results in enhancing their solubility and dissolution characteristics. With modern sophisticated techniques, precise mass production of oral films has been given a thrust. Oral films have better patient compliance, improved biopharmaceutical properties, improved efficacy, and better safety. By applying QbD and implementation of modern technologies the newer generation of oral films are yielding promising results.

4. Glibenclamide-Nicotinamide Cocrystals Synthesized by The Solvent Evaporation Method to Enhance Solubility and Dissolution Rate of Glibenclamide
Arif Budiman, Sandra Megantara, Ayu Apriliani, Tazyinul Qoriah
Purpose: To develop glibenclamide-nicotinamide cocrystals with the solvent evaporation method and evaluate their solubility and dissolution properties. Methods: Cocrystals of glibenclamide-nicotinamide (1:2) were prepared with the solvent evaporation method. The prediction of interactive cocrystals was observed using in silico method. The solubility and dissolution were performed as evaluation of cocrystals. The cocrystals also were characterized by differential scanning calorimetry (DSC), infrared spectrophotometry, and powder X-ray diffraction (PXRD). Result: The solubility and dissolution profile of glibenclamide-nicotinamide cocrystal (1:2) increased significantly compared to pure glibenclamide as well as its physical mixture. Characterization of cocrystal glibenclamide-nicotinamide (1:2) including infrared Fourier transform, DSC, and PXRD, indicated the formation of a new solid crystal phase differing from glibenclamide and nicotinamide. Conclusion: The confirmation of cocrystal glibenclamide-nicotinamide (1:2) indicated the formation of new solid crystalline phases that differ from pure glibenclamide and its physical mixture.

5. Pharmaceutical Polymers – A Review
Naveen Kumar, Sonia Pahuja, Ranjit Sharma
Humans have taken advantage of the adaptability of polymers for centuries in the form of resins, gums tars, and oils. However, it was not until the industrial revolution that the modern polymer industry began to develop. Polymers represent an important constituent of pharmaceutical dosage forms. Polymers have played vital roles in the formulation of pharmaceutical products. Polymers have been used as a major tool to manage the drug release rate from the formulations. Synthetic and natural-based polymers have found their way into the biomedical and pharmaceutical industries. Synthetic and Natural polymers can be produced with a broad range of strength, heat resistance, density, stiffness and even price. By constant research into the science and applications of polymers, they are playing an ever-increasing role in society. Diverse applications of polymers in the present pharmaceutical field are for controlled drug release.  Based on solubility pharmaceutical polymers can be classified as water-soluble and water-insoluble. In general, the desirable polymer properties in pharmaceutical applications are film forming, adhesion, gelling, thickening, pH-dependent solubility and taste masking. General pharmaceutical applications of polymers in various pharmaceutical formulations are also discussed briefly.

6. An Epidemiological and Diagnostic Study of Anaplasma ovis Parasite in Native Goats in Anbar Province- Iraq
Suad Shallal Shahatha
This study was conducted to investigate the epidemiology of Anaplasma ovis parasite in the native goat of some areas in Anbar province (Ramadi, Fallujah, Khalidiya, Hit and Baghdadi), by collecting 156 blood samples of both sexes and different ages ranging from one month to nine years for the period from March 2017 to February 2018, the parasite was diagnosed with microscopic examination using Giemsa stain. The results showed a total infection rate 34.6%, the infection rate in females was 38.8% higher than that of males 29.5% and significant differences (p≤ 0.05). The highest rate of infection (40, 39.5%) was observed for the age group 4-5 years and 6-7 years respectively. The highest rate was 75% in April and lowest rate 18.1% in February. The study also included a number of hematological parameters, which showed a decrease in total erythrocyte count (RBC), hemoglobin concentration (Hb), packed cell volume (PCV) in the infected goats.

7. An Epidemiological, Diagnostic and Therapeutic Study of Giardia lamblia in Anbar Province – Iraq
Suad Shallal Shahatha
This study was carried out to investigate the epidemiology of Giardia lamblia parasites in patients who visited some of the hospitals in Anbar province, which included (Fallujah Teaching Hospital, Ramadi Teaching Hospital, Ramadi Teaching Hospital for Women and Children and Hit Hospital) during by examining 864 stool samples in a direct examination method, The results revealed the infection rate was 41.7 % and the percentage of infection among males 47.8% is higher than that of females 35.4% with significant differences (p≤0.05). The age groups (1-9) years recorded the highest rates 55.4% and the lowest rate 13.6% in the age group (40-49) years. The highest rate of infection was 62.5% during the month of June, while the month of October was the lowest rate 5% and significant differences. The incidence rate in rural areas was 50.6% higher than in the urban areas 32.5%. The study also included the effect of Teucrium polium L. on the parasite in the culture media HSP-1, the concentrations of 0.5-3 mg / mL significantly affected Giardia, it was noted whenever the greater the concentration, the greater the effect during different treatment periods (1-4) days, as the highest concentration 3 mg/ml killed all Giardia parasites on the fourth day of treatment.

8. Identification Pseudomonas aeruginosa by OprD Gene for Differentiation from Other Pseudomonas Species that Isolated from Clinical Samples
Ashwak B Al-Hashimy, Khalid R Majeed, Akeel K Albuaji, Huda S Alagel
The present study included the collection of 100 samples from various clinical sources for investigating the presence of  P. aeruginosa  in those sources, the samples have been collected from some hospitals in Baghdad and Hillah city (Al-qassim General Hospital, ,Al-hillah teaching hospital,and Al-hashimya General hospital ) which included wounds, burns, ear and sputum infections. The study was carried out through October 2017 till the end of March 2018. The samples were identified based on the morphological and microscopically characteristics of the colonies when they were culturing or number of culture media as well as biochemical tests, molecular identification were also used as a final diagnostic test for isolates that were positive as they belong to P.aeruginosa bacteria during previous tests based on the OprD gene which has specific sequences for P.aeruginosa bacteria as a detection gene and also consider as  virulence factor so it have  a synonyms mechanism to antibiotic resistance . The results of the final diagnosis showed that 38 isolates belong to target bacteria were distributed as 18 of burns, 11 isolates of wounds, 6 isolates of ear infection and 3 isolates of sputum, The examination of the sensitivity of all bacterial isolates was done for elected 38 isolation towards the 9 antibiotic by a Bauer – Kirby and the isolates were resistant for a number of antibiotics used such as Ciprofloxacin 65.7%, Norflaxacin 71%, Imipenem 63.1% Meropenem 68.4%, Gentamicin 65.7%, Amikacin 26.3%, Cefepime 68.4%,  Ceftazidime 65.7% and Piperacillin 57.8%.Molecular method , All isolates (38) of P. aeruginosa positive for the diagnostic special gene (OprD) genes (100%).

9. Formulation and Evaluation of Teneligliptine Pellet
Bodhle Priyanka Raju, Satish V Shirolkar
The present study is an attempt to formulate and evaluate Teneligliptin hydrobromide hydrate pellets. Teneligliptin is a potent, selective DPP-4 inhibitor, which is believed to exert its actions in diabetes mellitus patients. Teneligliptin increases insulin release and decreases glucagon levels in the circulation in a glucose dependent manner. The Teneligliptin pellets were prepared by using blend of MCC, Lactose, Crospovidone and PVP K-30. Pellet formulation was optimized for formulation parameters (concentration of Crosspovidone and PVP K-30) using 32 factorial design. FTIR studies showed absence of chemical interaction between the drug and polymer. The pellets were prepared and evaluated in terms of bulk density, tapped density, angle of repose and in-vitro release study. In-vitro release of drug was compared with in-vitro release of drug from marketed formulation (Dynaglipt Tablet).

10. Anticancer Nano Formulation of Imatinib with Chitosan Polymer
Senthilnathan B, Vivekanandan K, Bhavya E, Chaarmila Sherin C, Billy Graham R
Objective: Drug targeting is the capacity of the dosage form. In which the therapeutic agent acts specifically to desired site of action in the non-targeted tissue with the help of Nano particles is called as the drug targeting. IMATINIB is a used to treat cancer by chemo therapy. Cancers like chronic myeloid leukemia cancer (CML) and acute lymphoblastic leukemia cancer (ALL) and other specific types of gastrointestinal stromal cell tumor (GIST) systemic mast cell disease and Bone marrow failure disorder. It is administered by oral root. For ATP, Tyrosine kinase is act as a binding site. Methodology: The drug IMATINIB is loaded in the polymer chitosan, poly-(D) glucosamine is a bio compactible, bio degradable, nontoxic, antimicrobial and soluble in solvents. This preparation is done by emulsion-droplet coalescence method. Content of the Drug, Size of the particle and Zeta potential, Encapsulation efficiency and Drug release testing are described for this formulation in this study. Results: The Imatinib Nano particles were formulated and evaluated for its invitro drug release profile. Based on the invitro drug release profile of Imatinib nano particles formulation (INP1 – INP5) formulation INP3 was selected as the best formulation in which the particle size was 285.9nm. The invitro % drug release of INP3 formulation was 99.76 ± 0.82 and it was found to be the suitable formulation to manage the cancer.  Conclusion: Hence it is concluded that the newly formulated controlled release nanoparticle drug delivery system of Imatinib may be idol and effective by allowing the drug to release continuously for 24 hrs.

11. Optimization of Sumatriptan Succinate Transdermal Emulgel For Treatment of Migraine
Jagdale Swati, Maganageri Priyanka
Purpose: Sumatriptan succinate is a BCS class III drug. Oral administration of drug suffers from poor bioavailability problem due to pre-systemic metabolism. Bioavailability for oral route is 15%, for nasal route is 17% and for parenteral route is 97%.  Substantial proportion of patients suffers from severe nausea or vomiting during their migraine attack, which make oral treatment unsatisfactory. Transdermal delivery will overcome the problems of the drug giving better results to patients suffering from migraine. Methods: Oleic acid, labrafil M 1994 and transcutol P was used as oil, surfactant and cosurfactant respectively. Both the oily and aqueous phases were heated separately. Oily phase were added to the aqueous phase. Mixing of gel and emulsion in ratio of 1:1 gave emulgel. Emulsion was evaluated for globule size, zeta potential, drug content, stability etc. Carbopol 934 and Xanthan gum was used as a gelling agent. Optimization was carried by factorial design. Emulgel was evaluated for physical parameters, viscosity, drug content, bioadhesive strength, spreadability, in-vitro and ex-vivo diffusion study. Results: FE-SEM image shown spherical globules in shape with size 51.40 µm. Zeta potential showed good stability of the emulsion.  FTIR and DSC studies revealed that drug and all excipients were compatible. Factorial design gave batch F7 as optimized one. ANOVA results shown that drug release and gel viscosity values are strongly dependent on concentration of carbopol 934 and xanthan gum respectively. Ex-vivo diffusion study for batch F7 through goat skin indicated 88.68±2.52 % drug release. Statistical studies showed that drug release from the optimized formulation (F7) followed First order release kinetics. Conclusion: Sumatriptan succinate emulgel act as depot of drug which releases drug in controlled manner overcoming oral route side effects.

12. The Effectiveness of Chloramphenicol In-Situ Opthalmic Gel with Base Poloxamer 407 and HPMC Against Staphylococcus Aureus Atcc 29213 And Pseudomonas Aeruginosa Atcc 27853
Insan Sunan Kurniawansyah, Norisca Aliza Putriana, Sri Agung Fitri Kusuma, Tan Mei Lee
Introduction: In-situ gel is a simple liquid transparent polymer solution under storage conditions, but turns into a viscoelastic gel after entering the eye due to the phase transition properties of the polymer that increase the residence time in ocular organ and bioavailability, enabling the delivery of reproducible doses and improving patient compliance. The aim of the present study was to formulate and evaluate the antibacterial effectivity of chloramphenicol in-situ ophthalmic gel with base poloxamer 407 and HPMC base against Staphylococcus aureus and Pseudomonas aeruginosa. Material and Methods: The optimization of ophthalmic gel preparation by the factorial design method has been carried out in order to know the best formula of all the formulas employed with 0.5% chloramphenicol active substance, wherein each formula was obtained from high concentration and low concentration of each base. Results: The measurement of the antibacterial effectivity against Staphylococcus aureus ATCC 29213 and Pseudomonas aeruginosa ATCC 27853 by one-way ANOVA analysis showed that formula with base poloxamer 407 5% (F1) gave the best result. F1 has a dilute consistency, clear and stable during 28 days storage time when effectiveness test performed. Conclusions: Chloramphenicol in-situ gel with base poloxamer 407 and HPMC were effective against Staphylococcus aureus ATCC 29213 with intermediate to sensitive category, and Pseudomonas aeruginosa ATCC 27853 with sensitive category in accordance to the requirements of the Clinical and Laboratory Standards Institute (CLSI).

13. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Gatifloxacin and flurbiprofen Sodium in Eye Drops
Pinkal Patel, Nalini Patel, Kinjal Parmar
A simple, selective and rapid reversed phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed and validated for the simultaneous analysis Gatifloxacin and flurbiprofen sodium in eye drops. The separation was carried out using a mobile phase consisting ACN: Buffer (pH 3.5) in the ratio of 55:45 v/v. The column used was Phenomenex luna ODS C18 (250mm X 4.6 mm i.d., 5 μm particle size) with flow rate of 1 ml / min using UV detection at 268  nm. The described method was linear over a concentration range of 2-12 μg/ml for both of Gatifloxacin and flurbiprofen sodium. The retention times of Gatifloxacin and flurbiprofen sodium were found to be 3.710 min. and 6.797 min respectively. Method was validated statistically and recovery studies were carried out. The proposed method has been applied successfully to the analysis of cited drugs either in pure form or in pharmaceutical formulations with good accuracy and precision. The method here in described can be employed for quality control and routine analysis of drugs in pharmaceutical formulations.

14. Development of Carrageenan Polymer for Encapsulation of Ciprofloxacin HCL: In Vitro Characterization
Hariyadi D M, Hendradi E, Sharon N
This study reported the properties of microspheres based Carrageenan polymers with Ciprofloxacin HCl antibiotic as a model for dry powder inhalation (DPI). Microspheres Ciprofloxacin-Carrageenan was prepared through ionic gelation process which is a widely used microencapsulation technique in the pharmaceutical industry. Microspheres formula consists of formula using 0.5 and 1% carragenan polymer and 0.2 and 0.6% KCl crosslinker which was named as F1, F2, F3 and F4. Microspheres were characterized for their yield, morphology, entrapment efficiency, drug loading and particle size. Results revealed that ionic gelation technique was a suitable technique for preparation of microspheres as most of the formulations were small in size, spherical in shape with a good yield of 46% to 89%. Based on the data of various evaluations such as drug entrapment efficiency, drug loading and particle size, formula F3 was found as the best DPI formula. Microspheres were successfully prepared and this study can be concluded that the developed microspheres of ciprofloxacin HCl-Carrageenan can be used for pulmonary system to improve the release mechanism and drug bioavailability.

15. Characteristics and Stability of Nanostructured Lipid Carrier (NLC) Aleurites Moluccana Seed Oil (AMs oil) Using Various Combinations of Beeswax and Oleum Cacao
Tristiana Erawati M, Denara Asha Putri, Arum Sekar Maharani, Noorma Rosita, Widji Soeratri
This study aims to determine the effect of the combination of beeswax and oleum cacao on the characteristics and stability of nanostructured lipid carrier-aleurites moluccana seed oil (NLC-AMs oil). The combination ratio of beeswax-oleum cacao and AMs oil is 3:1 which total lipid 20%, while the ratio of beeswax-oleum cacao used were F1(100:0); F2 (50:50); F3 (25:75); and F4 (0:100). These preparations are made by the high shear homogenization method because the processing technique is relatively easier, faster and it is possible to get nanoparticle size. Then characterization and physical stability test (real time, thermal cycling test, and centrifugation) were carried out. The results of this study can be concluded that: 1) NLC-AMs oil with combinations of beeswax and oleum cacao has smaller particle size than those using only single solid lipids (oleum cacao or beeswax). 2) Increased concentration of oleum cacao in the NLC-AMs oil system increases its viscosity. 3) The ratio of beeswax and oleum cacao affects the recrystallization index of the NLC-AMs oil. The lowest recrystallization index is in the NLC-AMs oil with a combination of beeswax-oleum cacao in F2 (50:50). 4) The results of the real time stability test for 8 weeks of storage revealed the NLC-AMs oil system with a combination of solid fat beeswax and oleum cacao on F3 (25:75) had the best stability. 5) All formulas are not stable against extreme temperature changes (thermal cycling test) and shocks (centrifugation) indicated by system separation.

16. A Review on Status of Nanotechnology in Pharmaceutical Sciences
Ashish Suttee, Gurpal Singh, Nishika Yadav, Ravi Pratap Barnwal, Neha. Singla, Kirti. S. Prabhu, Vijay Mishra
The most important unit operation in pharmacy is the size reduction. Improved stability, reduced toxicity, increased bioavailability, increased rate of release and good drug formulation opportunities accomplished by size reduction. In present days, the performance of various dosage forms has been increased in nanometer size. The cargo size of a specified unit, for example nanometer is 10-9 meter. The process which occurs in nano-length size or molecular size level is referred as nanotechnology. It has shown great development in engineering, physics and electronics but pharmaceutical field and medical field needs more development. Although, it has vast application in medical field like immunology, cardiology, bioengineering, oncology, ophthalmology, cardiology etc. In pharmaceutical field, it also provides excellent materials, devices and system. The present status of nanotechnology in pharmaceutical field may be counted as development as biomarkers, biosensors, nano medicine, tissue engineering, nano-robots etc. For developing new technology, as old reaches up to the limits nanotechnology gives great opportunities.

17. Formulation of Topical Gel from Extract of Berberis aristata DC for Acne
Shyam Baboo Prasad, Darshpreet Kaur, Yashwant
In current study, an attempt has been taken to formulate Topical gel of ethanolic extract of  Berberis aristata DC for antiacne activity. The gel containing extract was prepared by adding gel-forming material in sterile distilled water while the mixture was stirred and allowed to stand to hydrate. Extract was added in PEG 400 and polyethylene glycol mixture. Methyl paraben and propyl paraben were added as the preservative and triethanolamine was added as the neutralizer. The anti-acne activity was investigated against two causative bacteria, i.e., Propionibacterium acnes and Staphylococcus epidermidis and yeast (Malassezia furfur) by the well diffusion method. The result showed that gel passes all test of evaluation and was found to be active against acne causing microorganisms. Extract based gel has potential activity against acne-causing microorganism.

18. Biomedical Potential of Graphene oxide based Nanoformulations: An Overview
Vijay Mishra1, Gurpal Singh2, Nishika Yadav1, Ravi Pratap Barnwal3, Neha Singla3, Kirti. S. Prabhu4, Ashish Suttee

Graphene oxide is graphene-based two dimensional material and structure based on single sheet of carbon atoms arranged in hexagonal lattice or honeycomb framework. Graphene oxide is better than graphene in terms of dispersion in polar solvents due to oxygen-containing functional groups attached with carbon sheets, results as researchers to get indulged in this molecule. Graphene oxide has been attracted researchers in different fields like chemistry, physics and materials science. Graphene oxide has endless potential applications in building materials, environmental protection, electronics, medicine, pharmaceutical industries etc. In medicinal industry, graphene oxide used as antibacterial, antimicrobial and antifungal agent. Its potential activity with other nanoparticles as antifungal agent has come in light and became the main focus of going on works on graphene oxide. The antifungal property of GO-Ag composites was investigated. Furthermore, nanoparticles show great potential in the fields of biomedical, because of their antifungal properties. The GO-Ag composites act as alternative antifungal material. Moreover, antifungal activity of Reduced Graphene Oxide (rGO) nanosheets is also researched.

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