Handbook of Pharmaceutical Manufacturing Formulations Volume by Sarfaraz K. Niazi

By Sarfaraz K. Niazi

The 3rd quantity within the six-volume guide of Pharmaceutical production Formulations, this ebook covers liquid medicines, which come with formulations of non-sterile medicines administered via any course within the type of ideas (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emulsions, aerosols, and different fluid arrangements from publicly to be had yet broadly dispersed info from FDA New Drug purposes (NDA), patent purposes, and different assets of well-known and proprietary formulations. every one access starts off with a completely confirmed scaleable production formulation and a precis of producing procedure. The booklet offers an in depth dialogue at the problems encountered in formulating and production liquid medications and the typical parts of formula. The part on regulatory and production suggestions offers with the subjects of adjustments to licensed NDAs and aNDAs, post-approval adjustments to semisolid medicines, worldwide production practices and instructions, compliance application counsel guide for FDA employees overlaying drug production inspections software, waiver of in vivo bioavailability stories for instant free up good medications in accordance with a biopharmaceutics class, as well as delivering quickly tips about resolving the typical difficulties in formulating uncompressed medications.

Show description

Read or Download Handbook of Pharmaceutical Manufacturing Formulations Volume 3 of 6: Liquid Products PDF

Similar manufacturing books

ASM Handbook, Volume 20: Materials Selection and Design

ASM guide, Vol. 20: fabrics choice and layout fabrics choice and layout is a complete reference at the easy ideas, methodologies, and knowledge resources facing fabrics choice and its integration with engineering layout procedures. It makes the relationship among layout and fabrics engineering.

Additive manufacturing

Conceptually, 3D printing or layered production is the way to construct components with no utilizing any part-specific tooling or dies from the pc aided layout (CAD) dossier of the half. this present day such a lot engineered units are 3D revealed first to ascertain for his or her form, measurement, and performance earlier than large-scale creation.

Fundamentals of Manufacturing 3rd Edition

Basics of producing, 3rd version presents a dependent evaluation for the producing Technologist and production Engineer Certification Examinations. This ebook has been up to date in keeping with the newest model of the producing basics "Body of data" released by way of the qualified production Technologist and licensed production Engineer Oversight & Appeals Committee of the Society of producing Engineers.

Extra resources for Handbook of Pharmaceutical Manufacturing Formulations Volume 3 of 6: Liquid Products

Example text

A kit containing a vial of diluent). A smallvolume parenteral may be packaged in a disposable cartridge, a disposable syringe, a vial, an ampule, or a flexible bag. A large-volume parenteral may be packaged in a vial, a flexible bag, a glass bottle, or in some cases, as a disposable syringe. Cartridges, syringes, vials, and ampules are usually composed of Type I or II glass or of polypropylene. Flexible bags are typically constructed with multilayered plastic. Stoppers and septa in cartridges, syringes, and vials are typically composed of elastomeric materials.

It may be advisable to obtain a quantitative extraction profile of an elastomeric or plastic packaging component and to compare this periodically to the profile from a new batch of the packaging component. Extractables should be identified whenever possible. For a glass packaging component, data from Containers: Chemical Resistance — Glass Containers will typically be considered sufficient evidence of safety and compatibility. , for some chelating agents), a glass packaging component may need to meet additional criteria to ensure the absence of significant interactions between the packaging component and the dosage form.

For LDPE components, data from Containers tests are typically considered sufficient evidence of compatibility. The General Chapters do not specifically address safety for polyethylene (HDPE or LDPE), polypropylene, or laminate components. g. HDPE, LDPE, polypropylene, laminated components) into a liquid-based oral dosage form is expected to be comparable to a patient’s exposure to the same substances through the use of the same material when it is used to package food.

Download PDF sample

Rated 4.21 of 5 – based on 39 votes