Deepak Kaushik

Cosmeceuticals: An emerging concept

The use of cosmeceuticals has drastically risen in recent years. This significantly increases the armamentarium of the clinician in improving the treatment of skin, hair, and other conditions. They are at the juncture where wellness meets beauty and growing use by consumers is indicative of their popularity. This article focuses on skin, hair, and other cosmeceuticals and their regulatory aspects.

Recent Patents and Patented Technology Platforms for Pharmaceutical Taste Masking

Taste masking is an important factor in the development of oral dosage forms containing bitter active pharmaceutical ingredients. Currently numerous techniques are being applied to overcome this problem. Realizing this, several researchers and pharmaceutical companies are now engaged in developing novel techniques to address the problem of taste masking evident by numerous patents filed in this area in recent times. In this review the most recent patents for taste masking are discussed and how these patents overcome the limitations of conventional approaches of taste masking is also highlighted. Novel techniques based on some recent patents such as nanohybrid, melt extrusion, non-complex cyclodextrin compositions and off taste masking are providing new realms to taste masking of bitter drugs. The present article also provides an overview of various patented platform technologies based on different techniques/mechanisms employed for taste masking. The unique features and principles of taste-masking approaches used in various patented technologies are also discussed. A better understanding of these new patents and patented technologies will help researchers and pharmaceutical industries to select the appropriate platform, or to develop innovative products with improved taste masking properties.

Box-Behnken Designed Fluconazole Loaded Chitosan Nanoparticles for Ocular Delivery

Box-Behnken Designed Fluconazole Loaded Chitosan Nanoparticles for Ocular Delivery The present study aimed to develop chitosan nanoparticles containing Fluconazole for ocular delivery using Box-Behnken design. The Fluconazole loaded chitosan nanoparticles were prepared by an ionic gelation method using Sodium tripolyphosphate (NaTPP) as cross linking agent. The effect of the factors - concentration of chitosan (x1), concentration of NaTPP (x2) and volume of NaTPP (x3) was studied on release of drug from nanoparticles. The results revealed that entrapment efficiency was highest at low level of chitosan concentration, high level of NaTPP concentration and low levels of NaTPP volume. The optimized batch (NP 3) showed encapsulation efficiency of 63.1%, particle size of 471 nm, ovoid shape surface morphology and in vitro cumulative percentage of drug release 39.19% in 7 h.

Co-Processed Excipients: A Patent Review

The introduction of high speed tableting machines and the preference of direct compression as a method of tableting have increased the demands on the functionality of excipients mainly in terms of flowability and compressibility. Co-processed excipients, where in, excipients are combined by virtue of sub-particle level interaction have provided an attractive tool for developing high functionality excipients. The multifold advantages offered by co-processed excipients such as production of synergism in functionality of individual components, reduction of companys regulatory concern because of absence of chemical change during co-processing and improvement in physico-chemical properties have expanded their use in the pharmaceutical industry. In the recent years, there has been a spurt in the number of patents filed on co-processed excipients. Hence, the present review focuses on co-processed excipients and their application in pharmaceutical industry. The worldwide databases of European patent office (http://ep.espacenet.com) and United States patent office (www.uspto.gov) were employed to collect the patents and patent applications. The advantages, limitations, basis for the selection of excipients to be co-processed, methods of co-processing and regulatory perspective of co-processed excipients are also briefly discussed.

Self Emulsifying Drug Delivery System (SEDDS) for Phytoconstituents: A Review

The self emulsifying drug delivery system (SEDDS) is considered to be the novel technique for the delivery of lipophillic plant actives. The self emulsifying (SE) formulation significantly enhance the solubility and bioavailability of poorly aqueous soluble phytoconstituents. The self emulsifying drug delivery system (SEDDS) can be developed for such plant actives to enhance the oral bioavailability using different excipients (lipid, surfactant, co solvent etc.) and their concentration is selected on the basis of pre formulation studies like phase equilibrium studies, solvent capacity of oil for drug and mutual miscibility of excipients. The present review focuses mainly on the development of SEDDS and effect of excipients on oral bioavailability and aqueous solubility of poorly water soluble phytoconstituents/ derived products. A recent list of patents issued for self emulsifying herbal formulation has also been included. The research data for various self emulsifying herbal formulation and patents issued were reviewed using different databases such as PubMed, Google Scholar, Google patents, Scopus and Web of Science. In a nutshell, we can say that SEDDS was established as a novel drug delivery system for herbals and with the advances in this technique, lots of patents on herbal SEDDS can be translated into the commercial products.

Development Of Timolol Maleate Loaded Chitosan Nanoparticles For Improved Ocular Delivery

BACKGROUND The poor retention and penetration are the major issues in the bioavailability of drugs through ocular route. Recently, the natural polymers have been exploited for the development of nanoparticles to improve the ocular performance of various drugs. In the present investigation, nanoparticles of timolol maleate (TM) were developed by using chitosan polymer to improve its release through ocular delivery. METHOD Ionic gelation method was used for the development of timolol loaded chitosan nanoparticles by using a cross linking agent, sodium tripolyphosphate (NaTPP). The Box- Behnken design was used for the optimization of various parameters for the development of nanoparticles. OBJECTIVE The objective behind the study was to study the effect of three critical parameters; concentration of chitosan (X1), the concentration of NaTPP (X2), and the volume of NaTPP (X3) on the drug release from the prepared nanoparticles. RESULTS The results obtained showed that high level of the chitosan concentration and low level of the NaTPP concentration and the mid levels of the NaTPP volume resulted in high levels of encapsulation efficiency. The loading capacity was found maximum at a low level of chitosan and mid level of volume of the NaTPP with a low level of NaTPP concentration. The optimized batch (NP-2) showed that the entrapment efficiency was 75.34±0.17%, the particle size of 190.9 nm and in vitro cumulative percentage of drug release was 49.11±0.49% in 12 h. CONCLUSION The study concluded that chitosan nanoparticles loaded with timolol maleate resulted in improved drug release for ocular treatment.

Compulsory licensing of drug products in developing countries

Compulsory licensing of drug products is a very hot issue in today’s pharmaceutical world. Compulsory licensing of a drug product allows the government to issue the license of manufacturing the drug to a third person. The third person has to give some 5–10% royalty to the patent holder (the quantum of royalty is decided by the government and not by the patentee). The issue emerged after developing nations were given TRIPS flexibilities to implement the system when lives of large population are at stake. Compulsory licenses have been given in many countries like Thailand, Brazil, Mozambique, Zimbabwe, Zambia, Rwanda, Malaysia, Indonesia and recently India. India issued compulsory license over Bayer’s anticancer drug Naxaver (Sorafenib) to generic company Natco Pharma Ltd. United States has criticized the Indian decision. United States has also put Thailand on watch list after Thailand has issued compulsory licenses to three antiretroviral drugs. Compulsory licensing of drug products is very beneficial for the patients but is considered a big threat for the pharmaceutical companies. The branded drug makers spend billion dollars to patent a drug product. It is claimed by the pharmaceutical majors that the royalty of 5–10% given by generic drug makers to these companies is not enough to recoup their loss. The present article explores the utilization of “Compulsory Licensing” by several countries, exemplified by India and Brazil in particular, and highlights the patentees’ concerns of losing profits. The authors have attempted to negate the concern of the patentees over the use of compulsory licensing.

Regulatory perspectives on medical device approval in global jurisdictions

Today medical device sector is evolving to find the new horizons. Medical device approval is a time-consuming process that requires submission of safety, efficacy and quality documentation to national regulatory bodies in various countries. While there are some similarities among the countries regarding medical device regulations, some differences also exist that significantly affect the regulatory scrutiny. This presents a great problem for manufacturers marketing their products in multiple countries. Competent authorities worldwide have begun to realize the problem and collaborate to harmonize the regulations. In the present article regulatory approval procedure is discussed in different jurisdictions such as United States, European Union, Japan, China and India along with comparisons in terms of classification of devices, competent authorities, rules and regulations and quality management systems involved in these countries.

A comparative study of regulatory prospects for drug-device combination products in major pharmaceutical jurisdictions

In current scenario of innovative products, some of the products which hold a premier stand are those that combine, in some combination or others, elements of drugs, devices, and biologics. Drug-device combination products introduced a new change in medical product development, regulatory approval, and industrial interaction that provide valuable lessons for the development of new generations of medical products. These cutting-edge technologies have yielded the products to deliver drugs and biologics to specific targets within the body. In this paper, an introduction is given about combination products, their usefulness in the current drug delivery technologies, challenges in their regulation along with a brief history of these products, and overview of their regulatory status in major pharmaceutical jurisdictions. A brief review on regulatory path for their approval in various countries with special focus on drug device combinations along with the challenges faced by industries regarding their market approval is also given. For their market approval, the role and responsibilities of regulatory authority are addressed along with a brief description on review steps taken by Food and Drug Administration.