Here you find Six Volume in free for pdf of Handbook of Pharmaceutical Manufacturing Formulations written by Sarfaraz K. Niazi.

Pharmaceutical Formulation Handbook

Pharmaceutical Formulation Handbook, Six Volume Series found at home in R & D Laboratory of almost every pharmaceutical company, both generic and branded, and in the classroom pharmaceutical technology oggi And the supervisory agent uses this treatise to compare the quality of pharmaceutical products. In creating this work, in 2004, my main goal is to provide a ready source of safe and scalable pharmaceutical formulations that cannot be scaled which takes a long time to develop and spend substantial costs, to enable the availability of affordable drugs.

Part I includes regulatory guidance, formulation steps, references to active ingredients and excipients, and self-audit guidelines for CGMP compliance. Chapters of shared interest in all volumes distributed in six volumes, such as formulations for coating solutions are presented in volume 5 (OTC), although they are also related to volume 1. Part II includes a scalable formula and part III, if any, other general formulas. While the main focus of the guidelines provided in the handbook related to compliance with FDA requirements, this applies the same as the EU requirements, and, as a result, for any global agent.

The third edition also received several significant additions; Now every volume includes a Mandiri Audit Template, several chapters that advise the way to stay CGMP, including the most common FDA quote list to watch out for in the audit, the focus of global regulations, and the list of excipients and updated levels. From their merger in FDA-approved products. 

The formulation update is always cumulative because there is little need to remove any formulation given by Previustus - if it's true then, it will remain good now. However, various new drug delivery systems have evolved since the second edition was published, so I have included more details about this formulation, although some of them may not be available to practice because of the possibility of limitations on intellectual properties.

Volume One: Compressed Solid Products

The shape of the plasma concentration profile depends on the relative rate of absorption and elimination, and therefore plasma concentration profiles may vary with different routes of administration. Intravenous and sometimes intramuscular routes may produce early peaks due to rapid or near-direct absorption, while oral, subcutaneous, rectal, and other routes may exhibit delayed peaks due to the slow rate of absorption. In addition, it should be noted that the elimination rate is considered to be constant, as it depends mainly on the specific nature of the active substance of the drug.



Volume Two: Uncompressed Solid Products

Good Manufacturing Practices (GMP) is a universal concept with two goals: to make pharmaceutical products safe and sustainable. There have been remarkable changes in the basic approach to achieving these goals. The main regulations and guidelines for the production of finished pharmaceutical products (as opposed to the production of raw materials or active substances) are in this context.

Volume Three: Liquid Products

Liquid dosage forms provide an alternative to dosage forms that need to be swallowed. However, because water is a major component of most liquid dosage forms, the potency of the active drug in its formation and microbial contamination are major problems that require special attention. design quality (QbD): product objective (design experiments [DoE]), production resources (process analysis technology [PAT]) and acceptable product (quality system). Taste, sweetness, color and textures also present formative challenges because “there is no right method to solve it. Major beauty issues; "These are opportunities because there is no way to judge elegance dosage form.

Volume Four: Semisolid Products

Bioavailability (BA) and bioequivalence (BE) studies are expensive and, given the need for many of these studies to develop NDA or ANDA, there is always a need to address these needs on a scientific basis. This is particularly important for the generics industry, as generic competitors must keep their costs low to allow regulation to the lowest possible level. Recently, guidelines have emerged that may allow an exemption from BA and BE studies in certain situations. The contracting authority also has the means to challenge the request, and if the standard criteria are met, there is a very good chance of obtaining exemptions. These exceptions should apply to the following:


Volume Five: Semisolid Products

European legislation does not require mandatory routine manufacturing practice (GMP) control of active substance manufacturers. The responsibility for using only active substances manufactured in accordance with GMP rests with the manufacturing authorization holder. Art. 111 However, Directive 2001/83 / EC (Article 80 of Directive 2001/82 / EC for veterinary medicinal products) provides that GMP inspections at the places of manufacture of an active substance are to be carried out at the request of the manufacturer himself. The application for control must be submitted by the competent authority in the European Economic Area (EEA) where the site is located or, if there are sites in third countries, by the competent authority where the active substance is used as a starting material in the manufacture of medicinal products. If not, any EEA body can be contacted. There is no guarantee that such requests will be complied with if the competent authorities have to balance such requests with other priorities. 

Volume Six: Sterile Products

The formulator has many good options for selecting a filtration device. Although the author does not intend to promote a product or a specific brand, it is important to point out clear sources of information about critical steps. With comprehensive resources around the world, it should help select the right filtration system and provide filter verification methods. The new guidelines designed for aseptically filled products require a special implementation of filter validation, and the need to create a validation system cannot be overemphasized. The filter mixture is autoclaved before use and no damage should occur before using the filter assembly. Compatibility between the product and the hoses used to transport it is often critical and in some cases a certain class.


Click on the following Download: