Factors in formulation of Micro and Nanospheres

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Micro and nanospherical systems for drug delivery are fields of increasing concern in the present pharmaceutical development. The advantages of these devices over the conventional methods include increase in drug entrapment and loading ability, incorporation of both hydrophilic and hydrophobic drugs, target delivery and use of various route of administration for delivery of the drug, stability, dose reduction and protection from biodegradation, ease of formulating the controlled release system, improved bioavailability etc. The future potential of the system in performing the delivery of the drugs, genes, DNA, RNA, plasmids, oligonucleotides etc to the target site makes the study and investment in these kind of drug delivery even more productive. In the process of development of these systems, polymeric chains arrange to form a matrix inside which the drug may be entrapped, dispersed, dissolved within the microspheres and nanospheres or adsorbed at their surface. Various methods such as solvent evaporation, solvent removal, polymerization, hot-melt encapsulation, coacervation, phase/wet inversion, spray drying and spray congealing, etc. Among these, the solvent evaporation method is one of the most common patented methods and widely studied for the preparation of the nanospherical and microspherical systems.  However, it is imperative to understand the various formulation factors that are important while designing the system. One of the most important factors to be considered in the design and development of this system include the size as size affects the interaction with the biological system, entry of the drug and drug release.  Other important parameter to be kept in mind are the loading and entrapment efficiency which in turn are related to the productivity of the pharmaceutical system. This review discusses on the various formulation factors that should be kept in mind while designing the robust micro and nanospherical systems with better morphology, entrapment and release of the drugs.

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ROLE OF EXCIPIENTS IN DRUG STABILITY AND FORMULATION COMPATIBILITY

What happens if you are using cationic surfactants with Gellatin?
What happens if you are using Eudragrid RL along with drug having Carboxyl group?
Why can't you use Alpha and Beta cyclodextrins in parenteral formulations?

Many questions in mind............many problems in formulation. This link might be your Query solver. If not much, a little. With the model Diuretic class of drug and Excipient interaction, this slide explains it all.

Perhaps the first knowledgeable thing that my professional guru Shashikant Chaudhary taught me was -"If you know, excipient, you know your drug formulation". He was against changing all sorts of formulation parameter at the middle of development. A tiny change in the formulation and excipient leads to the marked change in the stability of the drug. So, if you are in the verge of developing a robust formulation, develop a robust vision on the relation between drugs and the excipients.

I have selected Diuretic class of Drugs, incorporating two biggest headache of a formulation developer: 1. Low Solubility 2. Low Permeability. and study of their excipient interaction.

Perhaps very few things have been put in net and journals  about this issue. I thought sharing this knowledge with my people so that a wise decision can be taken before developing any formulation.

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FACTORS TO BE CONSIDERED FOR SAFE DRUG EXCRETION

POWERPOINT PRESENTATION

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TABLET COMPRESSION TECHNOLOGY...FROM PAST TO FUTURE !!

GUNJAN SUBEDI

Compression is one of the most important step of   the Tablet formulation. It involves increase in mechanical strength of the tablet by the application of the pressure (load) to reduce the bulk volume by deformation of the particles and removal of the entrapped gases. Compression results in the formation of compact solid dosage form which offer the advantages of better handling, compactibility, increased stability, reduction in volume etc. because of  which, it can be taken readily.

Various approaches have been implemented for the formation of better tablet dosage form by modifying various parameters and instrumentation in the compression machine and compression process. The recent advances in compression  through the incorporation of the various new technologies like multi tip punches, Exchangeable Die Disc (EDD), turret and die shells (DS), micro tab punches, external lubrication etc , provide various other advances like Increased production rate, Reduced change over time, Decreased cleaning time, Extended service life and improved quality in production. 

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DRAWBACKS AND CRITICAL ANALYSIS OF THE PHARMACEUTICAL POLICIES OF NEPAL

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Till date, no separate Pharma Policy has been designed and implemented. We have
formulated the National Health policy with an objective of providing the essential health care
services to all the rural parts of the Nepal and this health policy also talks about the supply and
production of the essential drugs in the country. To achieve this, we have formulated the
National Drug Policy, which aims basically at making the nation self sufficient in the production
of the essential drugs. Monitoring and evaluation of progress made in implementation of
National Drug Policy was done twice. To improve the educational sector in pharmacy and to
regulate the pharmaceutical issues, we have formulated the Nepal pharmacy Council Act which
guides for the formation of Drug Advisory Board and Drug Advisory Committee. To make ease
the formation of the regulations of the Inspection and pharmaceutical Industry, we have formed
the Drug Act which eventually lead to the formation of Department of Drug Administration and
to assist it the National Medicines Laboratories. Brach offices of Department of Drug
Administration established in three regions of the country. National List of Essential Drugs
published in 1986 and revised in 1992, was revised in 1997 and 2002 and list was further
classified for district, primary health care centre, health post, sub-health post and primary
treatment level. Good Manufacturing Practices as per WHO guidelines was made compulsory for
registration of medicine. Eight custom points were identified for the importation of drugs. Drug
Information Network of Nepal was established and made functional. Nepalese National
Formulary was published in 1997. National Guidelines for Use of Pharmaceuticals for clinical
trial developed by Nepal Health Research Council.
We are still far in the good policy making sector and lot has to be improved especially in
the formulation of the plans to improve the Research and Development sector and production of
the vaccines, parenterals and biotechnological products. Also the drafted policy has also not been
implemented correctly. (discussed in PART II). A lot stress is still required for the good
inspection and control of the price and quality. Special focus has to be given to discard the
differences in the foreign policy and make it assessable for our drug products to get exported and
reach the International market The following section (PART-II) deals with the problems and
critical analysis of the major policies related to the pharmaceutical sector that needs to get
revised.

Gap Analysis: ISO 17025 and GLP

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There is a strong urgency to synchronize the laboratory practices so that a common standard of quality can be achieved. Two guidelines namely, the ISO 17025 and WHO Good practices for pharmaceutical quality control laboratories are especially helpful and being practiced in the pharmaceutical quality control laboratories around the world. The ISO/IEC 17025: 2005 released in May of 2005 as a second and the latest edition provides specific guidance on the application of the ISO 9001 principles to laboratories. These guidelines are consistent with the requirements of the WHO guidelines for good manufacturing practices, and with the requirements of the International Standard ISO/IEC 17025:2005, and provide detailed guidance for laboratories performing quality control of medicines. Compliance with this standard provides a globally accepted basis for laboratory accreditation. WHO Good practices for pharmaceutical quality control laboratories provide advice on the quality management system within which the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products should be performed to demonstrate that reliable results are obtained.      Both of these standards aim in acquiring international harmonization in Laboratory practices and services

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ISO 9001: INTRODUCTION AND PROCEDURES

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