Development of a Novel Vaginal Drug Delivery System to Control Time of Farrowing and Allow Supervision of Piglet Delivery.

The swine industry has evolved significantly in the recent decades, but this has come at considerable expense to piglet survival. Breeding sows for greater prolificacy has been accompanied by a greater proportion of piglets being born underweight, of lower vigor, and higher susceptibility to early mortality. Inducing sows to farrow during working hours has the potential to increase piglet survivability, but non-therapeutic injectable products are often discouraged on farms. We aimed to design and develop a novel vaginal drug delivery system (NVDDS) that could reliably trigger luteolysis and induce parturition. To achieve this, two vaginal tablets containing the luteolytic agent cloprostenol were formulated to be inserted together: one would release constituents immediately on insertion (immediate release; IR) and the other would release cloprostenol in a controlled manner (controlled release; CR). The two formulations (IR and CR) were evaluated for drug release, swelling and bio-adhesion in conditions simulating the sow vaginal environment. The IR tablet released the drug completely for 5 min whereas the CR tablet took 5 h to release 50% of the drug. Furthermore, the release kinetics were evaluated by fitting the dissolution profiles into different mathematical models. Both IR and CR tablets were best fitted by the Makoid-Banakar model which assumes release by summation of different mechanisms. The performance of the optimized formulations was studied in vivo with 161 Large White x Landrace sows of varying parity (0-5). The sows were assigned to five groups. Group 1 (SI) received a single vulval injection of cloprostenol at 0700 h ( n = 32), group 2 (SDI) received the same dose split in two parts, at 0700h and 1300h ( n = 33). Group 3 (IRT) animals were administered an IR tablet at 0700h ( n = 32), while group 4 (IRCRT) received both IR and CR tablets at 0700 h ( n = 33). Group 5 was untreated and served as a control ( n = 32). The interval to farrowing was longer ( p < 0.001) for controls than for treated sows, but there were no differences among cloprostenol treatments for timing of farrowing. The finding confirms the efficacy of the NVDDS for induction of farrowing in sows.