Month: October 2024

SOP for Preparation of Lyophilized Allergen Extracts

SOP for Preparation of Lyophilized Allergen Extracts Standard Operating Procedure for Preparation of Lyophilized Allergen Extracts 1) Purpose This SOP outlines the procedure for the preparation of lyophilized allergen extracts to ensure product stability and retention of allergenic activity during storage and reconstitution. 2) Scope This SOP applies to formulation scientists, operators, and QA personnel…

Lyophilized Products

SOP for Operation of Nasal Spray Filling Machines

SOP for Operation of Nasal Spray Filling Machines Standard Operating Procedure for Operation of Nasal Spray Filling Machines 1) Purpose This SOP describes the procedure for operating nasal spray filling machines to ensure accurate dosage and sterile filling. It includes steps to set up the machine, conduct the filling operation, and ensure proper sealing and…

Nasal Spray Formulations

SOP for Preparation of Double Emulsions (W/O/W or O/W/O)

SOP for Preparation of Double Emulsions (W/O/W or O/W/O) Preparation of Double Emulsions (W/O/W or O/W/O) 1) Purpose The purpose of this SOP is to outline the procedure for preparing double emulsions, such as water-in-oil-in-water (W/O/W) and oil-in-water-in-oil (O/W/O) emulsions. Double emulsions are complex emulsions where an internal phase is dispersed within an external phase,…

Liposome and Emulsion Formulations

SOP for Incorporation of Solubility Enhancers in Lyophilized Products

SOP for Incorporation of Solubility Enhancers in Lyophilized Products Standard Operating Procedure for Incorporation of Solubility Enhancers in Lyophilized Products 1) Purpose This SOP outlines the method of incorporating solubility enhancers into lyophilized formulations to improve the dissolution of poorly soluble active pharmaceutical ingredients (APIs) after reconstitution. 2) Scope This SOP applies to formulation scientists,…

Lyophilized Products

SOP for Use of Polymeric Micelles in Nanoparticle Formulations

SOP for Use of Polymeric Micelles in Nanoparticle Formulations Standard Operating Procedure for Use of Polymeric Micelles in Nanoparticle Formulations 1) Purpose This SOP describes the procedure for preparing polymeric micelles, which are used in nanoparticle formulations to solubilize poorly water-soluble drugs, improve bioavailability, and provide controlled drug release. 2) Scope This SOP applies to…

Nanoparticle Formulation

SOP for Operation, Cleaning, and Maintenance of Mixing Equipment

SOP for Operation, Cleaning, and Maintenance of Mixing Equipment Standard Operating Procedure for Operation, Cleaning, and Maintenance of Mixing Equipment 1) Purpose This SOP outlines the procedures for the operation, cleaning, and maintenance of mixing equipment used in nasal spray formulation. Proper operation ensures uniform mixing of ingredients, while routine cleaning and maintenance ensure equipment…

Nasal Spray Formulations

SOP for Preparation of Lyophilized Peptide Therapeutics

SOP for Preparation of Lyophilized Peptide Therapeutics Standard Operating Procedure for Preparation of Lyophilized Peptide Therapeutics 1) Purpose This SOP outlines the procedure for preparing lyophilized peptide therapeutics, ensuring that the bioactivity and stability of the peptide is maintained during lyophilization and storage. 2) Scope This SOP applies to all personnel involved in the formulation,…

Lyophilized Products

SOP for Preparation of Water-in-Oil (W/O) Emulsions

SOP for Preparation of Water-in-Oil (W/O) Emulsions Preparation of Water-in-Oil (W/O) Emulsions 1) Purpose The purpose of this SOP is to outline the procedure for preparing water-in-oil (W/O) emulsions. In W/O emulsions, water droplets are dispersed in an oil continuous phase, stabilized by emulsifying agents. These emulsions are used in various pharmaceutical, cosmetic, and food…

Liposome and Emulsion Formulations

SOP for Formulating Nanoparticles for Pulmonary Delivery

SOP for Formulating Nanoparticles for Pulmonary Delivery Standard Operating Procedure for Formulating Nanoparticles for Pulmonary Delivery 1) Purpose This SOP outlines the procedure for preparing nanoparticles for pulmonary drug delivery, where the formulation is optimized for inhalation and targeting the lungs, ensuring rapid drug absorption and minimal systemic exposure. 2) Scope This SOP applies to…

Nanoparticle Formulation

SOP for Preparing Lyophilized Formulations for Pediatrics

SOP for Preparing Lyophilized Formulations for Pediatrics Standard Operating Procedure for Preparing Lyophilized Formulations for Pediatrics 1) Purpose This SOP outlines the procedure for preparing lyophilized formulations for pediatric use, ensuring safety, palatability, and ease of administration. 2) Scope This SOP applies to all personnel involved in the formulation, preparation, and testing of lyophilized products…

Lyophilized Products