Research Journal of Pharmaceutical Dosage Form and Technology

D. Patil Namrata ¹, S. B. Gondkar ¹, R. B. Saudagar ²

Affiliations
1 Department of Pharmaceutics, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN

Abstract

Buccal route offers the advantage of avoiding first pass metabolism. Saxagliptin Hydrochloride in conventional dosage form is extensively metabolized by the liver. The Saxagliptin Hydrochloride is antidiabetic agent used in the treatment of type-II Diabetes mellitus. The oral bioavailability is 67%. The half-life of saxagliptin Hydrochloride is 2.5 hours and it undergoes hepatic metabolism. So, in order to improve the bioavailability and efficacy, we have prepared buccal patches of saxagliptin Hydrochloride. HPMC is one the polymers which is having good mucoadhesive property so therefore various formulations were developed by using release rate controlling HPMC K100M and Eudragit RL-100 by Solvent Casting technique. In addition to this propylene glycol - 400 was used as plasticizer and permeation enhancer respectively. Drug-excipients interaction study was proven if any. Buccal patches were characterized for number of parameters like Mechanical properties and , weight uniformity, thickness, Percent moisture loss, folding endurance, swelling index, surface pH, drug content uniformity, in-vitro residence time, drug-excipients interaction study, Mucoadhesive strength and in-vitro drug release study. 3² full factorial design was employed to study the effect of independent variables. The response of design was analyzed using Design Expert® trial version 7.0.0; and the tools of the software were used to draw Contour plot and 3D plot. On the basis of the software analysis, formulation F7 was selected as optimized formulation and evaluated for independent parameters. Optimized formulation showed 98.35 ± 0.52% dug release upto 6 hrs. Optimized formulation fulfils all necessary attributes required for Buccal Patch and can become a promising alternative to present marketed tablet of Saxagliptin Hydrochloride.

Keywords

Buccal Patches, Saxagliptin Hydrochloride (SXG HCL), Hydroxypropylmethyl Cellulose (HPMC), and Eudragit RL-100.

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Amit A. Dhengale ¹, Avinash B. Darekar ¹, R. B. Saudagar ²

Affiliations
1 Department of Pharmaceutics, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN

Abstract

Pulsatile drug delivery system are gaining a lot of importance as these system deliver the drug at specific time as per the pathophysiological need of disease ,resulting in improved patient compliance and therapeutic efficiency. Disease where in PDDS are promising include asthama, peptic ulcer, arthritis, cardio vascular disease, peptic ulcer, attention deficit syndrome in children and hypercholesteromia. PDDS can be classified in time controlled system where the drug controlled primarily by the delivery system, stimuli induced PDDS in which release is controlled by the stimuli, like the ph or enzyme present in the intestinal tract or enzyme present in drug delivery system and externally regulated system where release is programmed by external stimuli like magnetism, ultrasound, electric effect and irradiation. The current article focuses on the disease requiring PDDS, methodologies involved for the existing system, recent update and PDDS product currently available in the market.

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B. Desale Kishor ¹, A. B. Darekar ¹, R. B. Saudagar ²

Affiliations
1 Department of Pharmaceutics, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN

Abstract

Niosomes are non-ionic surfactant formation of vesicles by hydrating mixture of cholesterol and other lipids with or without incorporation. They are vesicular system that can be used as carriers of amphiphilic and lipophilic drugs. Niosomes are biodegradable, biocompatible, nonimmunogenic and exhibit flexibility in their structural characterization. Niosomes are preferred over liposomes because the former exhibit high chemical stability and economy. Different novel approaches used for delivering these drugs include liposomes, microspheres, nanotechnology, microemulision antibody loaded drug delivery, implantable pumps and niosomes. Niosomes are widely studied as an alternative to liposomes. They improve the therapeutic performance of the drug molecules by delayed clearance from the circulation, protecting drug from biological environment and restricting effects to target cells. This review article focuses on the advantages, disadvantages, preparation methods, factors affecting, characterizations, invitro methods, drug release kinetics, and application of niosomes.

Keywords

Niosomes, Vesicles, Biological Environment, Composition.

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S. B. Gondkar ¹, P. Shewale Lankesh ², R. B. Saudagar ²

Affiliations
1 Department of Pharmaceutics, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN

Abstract

The oral route is the most frequently used route for the administration of drugs. Many of the pharmaceutical dosage form are formulated as sustained release dosage form to retard the release of a therapeutic agent such that its appearance in the systemic circulation is prolonged and its plasma profile is sustained in duration. Tablets offer the lowest cost approach to sustained and controlled release dosage forms. Matrix tablets serves as an important tool for oral extended- release dosage forms. Hence, problems like patient compliance, drug targeting, local side effects, frequent administration and fluctuations in blood concentration levels. Conventional drug delivery systems are known to provide a prompt release of drug or immediate release drug product. Such immediate release products result in relatively rapid drug absorption and onset of accompanying pharmacodynamic effects. Hence, change in the operation is a suitable and optimized way to make the some drug more effective by slight alteration in the drug delivery. Pharmaceutical industries and academic laboratories have been focused on development of novel drug delivery system or modified release dosage form rather investigation and development of new drug. Advance in technology have resulted in novel modified release dosage form. In contrast to conventional form, modified release products provide either delayed release or extended release of drug.

Keywords

Hydrophilic and Hydrophobic Polymers, Matrix Tablet, Sustained Release Matrix Type Drug Delivery.

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Sushant R. Jagtap ¹, D. G. Phadtare ², R. B. Saudagar ²

Affiliations
1 Department of Quality Assurance Techniques, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN
2 Department of Pharmaceutical Analysis, R.G. Sapkal, College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN

Abstract

Microemulsions, which has considerable potential to act as a drug delivery system is becoming the area of interest for the pharmaceutical scientist. In pharmaceutical fields, the interest in microemulsion is increasing and, thus, they are applied to various administered routes. Being thermodynamically stable, these microemulsions are composed of an aqueous and an oil phase along with the surfactants. An understanding of the physicochemical and biopharmaceutical characteristics of microemulsion will provide guidance for the designing of their formulation. Besides the understanding of the formation and its characterization this article gives provides the knowledge of construction of the phase diagram of the microemulsion. This article also emphasis the recent developments and future discussions. Developments for poorly soluble drugs of microemulsion are also included in this review.

Keywords

Microemulsion, Structure, Advantage, Application.

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Pooja M. Nikam ¹, S. B. Gondkar ¹, R. B. Saudagar ²

Affiliations
1 Department of Pharmaceutics, R.G. Sapkal College of Pharmacy, Anjaneri, Nasik, 422003, IN
2 Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nasik, 422003, IN

Abstract

Nanotechnology is the science in which the particle having the size below 1000nm.Theimportance of nanotechnology in drug delivery is in the concept and ability to manipulate molecules and supramolecular structures for producing devices with programmed functions. One of the major application areas of nanotechnology in pharmacy is nanoparticular drug delivery system. Preparation of nanocrystals to improve the solubility of poorly water- soluble drug for oral delivery is also one of the important applications. Drug nanocrystals are crystals with a size in the nanometre nanoparticle with a crystalline character .The use of drug Nanocrystals is an universal formulation approach to increase the therapeutic performance of these drugs in any rout of administration.

Keywords

Nanocrystal, Top Down, Bottom Up, Application.

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Gunjan L. Zope ¹, A. B. Darekar ¹, R. B. Saudagar ²

Affiliations
1 Department of Pharmaceutics, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN

Abstract

In recent years the novel technology of floating drug delivery system formulations are designed for the new drugs for oral targeted drug delivery. The drugs are delivered by conventional dosage forms are having very short residence time, but the drugs which are act in stomach are have more residence time. The floating drug delivery systems are of particular interest for drugs drugs that are locally active and narrow absorption window in stomach. System which are retained in the stomach for a longer period of time and there by improve the bioavailability of drugs. In this review the various advantages are given which are very important for controlled drug delivery system. Floating drug delivery system have a bulk density less than gastric fluids. When the system floats on gastric contents the drug is released slowly at the desire rate from system. The polymers are suitable for floating drug delivery system are covered in this review.

Keywords

Floating Drug Delivery System, Mechanism and Types of FDDS, Evaluation of FDDS.

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Nikita S. Malekar ¹, S. B. Gondkar ², R. B. Saudagar ³

Affiliations
1 Department of Quality Assurance Techniques, R. G. Sapkal College of Pharmacy, Anjenari, Nashik-422213, Maharashtra, IN
2 Department of Pharmaceutics, R. G. Sapkal College of Pharmacy, Anjenari, Nashik-422213, Maharashtra, IN
3 Department of Pharmaceutical Chemistry, R.G.Sapkal College of Pharmacy, Anjenari, Nashik-422213, Maharashtra, IN

Abstract

Nasal therapy also called "Nasya Karma" has been recognized form of treatment in the Ayurvedic. System of Indian Medicine. Nowadays many drugs have better systemic bioavailability through nasal route as compared to oral administration. The nose is also considered an attractive route for needle-free vaccination and for systemic drug delivery, especially when rapid absorption and effect are desired. The nasal delivery is a feasible alternative to oral or parenteral administration for some drug because of the high permeability of the nasal epithelium, rapid drug absorption across this membrane and avidance of first pass metabolism. Prolonged drug delivery can be achieved by various new dosage forms like in-situ gel. In-situ forming polymeric formulation are drug delivery system that is in sol form before administration in the body, but once administered, undergoes gelation in-situ to form a gel. In-situ nasal drug delivery system is the type of mucoadhesive drug delivery system. Now a days insitu gel has been used as vehicle for the drug delivery of the drug for both local treatment and systemic effect. In-situ nasal gel drug delivery system is advantageous over the conventional drug delivery system like sustained and prolonged release of drug, reduced frequency of administration, improved patient compliance and comfort.

Keywords

Nasal Drug Delivery, Nasal In-Situ Gel, Mucoadhesive Drug Delivery System.

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S. Waghmare Sneha ¹, V. Kadam Trupti ¹, A. B. Darekar ¹, R. B. Saudagar ²

Affiliations
1 Department of Pharmaceutics, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN

Abstract

Systemic anti-infective agents are progressively utilized as a part of the treatment of periodontal contaminations. Whilst these medications are utilized basically on an experimental premise, a few doctors battle that discerning utilization of anti-infective ought to be the standard because of their wide ill-use and worldwide development of antiinfective safe living beings.

This is an audit of the standards and balanced anti-infective treatment, treatment objectives, drug conveyance courses and different anti-toxins utilized as a part of the administration of periodontal infections. The accessible information demonstrate, all in all, that mechanical periodontal treatment alone is satisfactory to enhance or determination the clinical condition as a rule, however adjunctive anti-infective agents, delivered systemically, can improve the impact of help in particular circumstances. This is especially valid for forceful periodontitis in patients with summed up systemic ailment that may influence host safety, and in the event of poor reaction to customary mechanical treatment. This article gives a redesign on systemic anti-infective treatment for the treatment of periodontitis.

Keywords

Anti-Infective Agents, Periodontitis, Metronidazole, Tetracycline, Clindamycin.

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Varsha R. Sandhan ¹, S. B. Gondkar ¹, R. B. Saudagar ¹

Affiliations
1 Department of Quality Assurance Techniques, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN

Abstract

The poor bioavailability and therapeutic response exhibited by conventional ophthalmic solutions due to rapid precorneal elimination of drug may be overcome by the use of ophthalmic gel systems. The purpose of the present study was to develop ophthalmic gel formulations of ketoconazole. Intraocular delivery of topically applied drugs such as ketoconazole is hampered by elimination of the solution due to tear turnover, so an mucoadhesive gel was formulated. Ketoconazole gels were prepared using sodium carboxymethylcellulose (NaCMC) as a mucoadhesive polymer and xanthan gum as a viscosity increasing agent. Gels were evaluated for various parameters like appearance, pH, drug content, gel strength, bioadhesion, viscosity, In-vitro drug release, isotonisity, sterility, antifungal activity, ocular irritancy and stability studies. The gel strength, bioadhesion and isotonisity shown quality parameter for ophthalmic formulation. The optimized formulation containing 1% w/v Na CMC and 0.2% w/v xanthan gum have shown 97.66% drug release up to 8 hrs. This is sufficient for antifungal activity. Diffusion studies have shown that a Korsmeyers-peppas is the best-fit model. This study found that an optimized formulation having improved viscosity and better mucoadhesive property may improve the bioavaibility of ocular administration of ketoconazole in gel form and can be alternative to the conventionally administered oral formulation and effectively used to prolong residence time.

Keywords

Ophthalmic Drug Delivery, Bioavaibility, Mucoadhesive Polymer, Fungal Keratitis.

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V. Kadam Trupti ¹, S. Waghmare Sneha ¹, A. B. Darekar ¹, R. B. Saudagar ²

Affiliations
1 Department of Pharmaceutics, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN

Abstract

Acne vulgaris is a standout amongst the most widely recognized skin issue of pilosebaceous follicle described by papules, knobs, growths, comedones, pustules and regularly scars essentially scattered on the face, midsection and upper back. Pimple inflammation is a typical skin ailment that includes individual of all ages. Skin inflammation is delivered by the gram positive anaerobic microorganism (Propionibacterium acnes) and perceived as discharge framing microbes. Diverse parts of restorative plants and dermatological medications are utilized for the treatment of skin inflammation. In topical specialists; benzoyl peroxide, anti-infection agents, retinoids, and so on are the backbone of treatment; can be given in combination. While systemic treatment incorporates oral anti-microbials, hormonal therapy, and isotretinoin, contingent on the need of patients it must be chosen. Physical treatment in the type of injury evacuation, photograph help is likewise useful in few of them. Since different old and new topical and systemic specialists are accessible to treat acne vulgaris, it at some point confound treating dermatologist.

Keywords

Acne Vulgaris, Propionibacterium Acnes, Staphylococcus Epidermidis.

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Dipti G. Phadtare ¹, Amol R. Pawar ², R. B. Saudagar ¹, Govind K. Patil ³

Affiliations
1 Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, IN
2 Department Quality Assurance Techniques, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, IN
3 University Institute of Chemical Technology, NMU, Jalgoan, IN

Abstract

The aim of present work research work was formulation and evaluation of stable montelukast sodium sublingual tablet. Since The thermal stress testing study of Monte in solutions at 65°C showed that it is highly stable in NaOH solution, while it degrades rapidly in both acidic and H₂O₂ solutions. Hence lyophilization technology was adopted to increase the stability of montelukast sodium. Before lyophilization three trials were carried out to optimize the process parameters in which Trial 2 was considered as optimized process. The Lyophilization was carried out in nine different batches by varying the total cycle time, freezing and holding time, primary drying and secondary drying time by maintaining the quantities of all the active pharmaceutical ingredients constant and selection of cryoprotectant ratio. An optimized lyophilization cycle of 56 hours has been achieved. The optimized lyophilized product was subjected to Tablet compression. In this process the batch-9 formulation was considered as an optimized Formulation for compression with the process. All the in-vitro evaluation parameters complies the limits as per the specification. Stability studies were conducted and from the result it was concluded that the optimized formulation was found to be stable. Finally, it is concluded that the lyophilization is a suitable technique to increase the stability and bioavailability of Montelukast sodium.

Keywords

Montelukast Sodium, Sodium Hydroxide, Hydroxypropyl Beta Cyclodextrin, Lyophilization, Freezing, Primary Drying, Secondary Drying.

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