What is a powder-in-bottle (PIB) or granules for reconstitution product?

The powder-in-bottle (PIB) or granules/powder for suspension approach is used to accelerate formulation development and introduce new chemical entities into Phase I clinical trials. The approach consists of granulating or compounding the active pharmaceutical ingredient (API) into a solution or a suspension in the clinic before dispensing by oral administration.

Most of the products on the market that are commercially available are antibiotics (penicillin v, or a suspension, e.g. ampicillin, azithromycin, vancomycin), antivirals (baloxavir or oseltamivir), histamine H2-receptor antagonist (ranitidine, famotidine, and cimetidine) for pediatrics which are reconstituted (usually with water) by the pharmacist and shaken to suspend the product before dispensing. Such preparations are formulated as granules for reconstitution and incorporate a sugar base for taste-masking and require the addition of a fixed volume of water. The reconstituted syrup may be in the form of a solution or suspension.

powder in bottle

The selection of excipients can impact the stability of the preparation. Syrups become less stable as the sugar content increases in some cases. Although syrups prepared according to the prescriber’s insert (PI) are not always the most stable, using different diluents on the stability of syrups, especially suspensions, suggests that syrups should always be reconstituted and diluted according to the directions provided with the product.

Mikart can assist in the formulation and development of these dosage forms with the ability to do small batch sizes and scale up to 1000 Kg of bulk powder blend. Mikart uses a net weight filler to ensure accuracy of fill weight. If you would like to learn more, please contact us below.