Physicochemical and microbiological stability of insulin eye drops in an artificial tear vehicle used in the treatment of refractory neurotrophic keratopathy.

Neurotrophic keratopathy (NK) is a degenerative corneal disease with a loss of corneal sensitivity and impairment of corneal healing. Low dose insulin eyedrops have been shown to be a simple and effective treatment for refractory NK when the response to the usual treatment is incomplete. At present, there are no commercially available forms, and there is no data regarding the stability of these products as prepared by compounding pharmacies. In this work, we studied the physicochemical and microbiological stability of an insulin ophthalmic formulation obtained by mixing insulin lispro in artificial tears with a polyethylene and propylene glycol base. The stability of this 1IU/mL insulin ophthalmic formulation was analysed for 12 months in low-density polyethylene (LDPE) multidose eye droppers at 4°C. The studied parameters of physicochemical stability were: visual inspection, turbidity, UV spectral absorption, osmolality and pH. In addition, insulin and m-cresol concentrations and quantification of impurities (insulin covalent aggregates and insulin fragments) were studied thanks to the development of a new Size Exclusion Chromatographic method. For unopened eye droppers, all tested physicochemical parameters remained stable for 12 months at 4°C, and excellent microbiological stability was obtained. In conditions of simulated use, these parameters also remained stable for one month at 4°C, and no impact of potential temperature rises on the insulin and m-cresol concentrations in the insulin eyedropper was observed.

[Galenic and analytic development of tacrolimus 0.06% eye drops]. / Développement galénique et analytique d'un collyre à base de tacrolimus 0,06 %

PURPOSE: The administration of topical tacrolimus (FK506) eye drops or ointment is effective in treating certain immunologic corneal diseases and in the prevention of rejection of high-risk corneal grafts. The purpose of this study is to determine the optimal formulation of tacrolimus 0.06% eye drops. A procedure for preparation is presented and discussed. METHODS: Tacrolimus monohydrate powder and virgin castor oil are used in this new formulation. The manufacturing process guarantees consistency of product sterility. Measurement by high-performance liquid chromatography allows precise control of the concentration of tacrolimus. RESULTS: The manufacture and packaging of tacrolimus 0.06% eye drops involve numerous controls allowing for guaranteed sterility and stability. The drops remained sterile and stabile for 28 days after opening regardless of storage conditions and can be stored for 3 months after manufacture. Tolerability studies are currently being performed.

Peritoneal drainage and ileostomy as a treatment for the acute necrotising enterocolitis.

Between 1982 and 1987, in the "Centre néonatal" of Rocourt (Belgium), 18 cases of necrotising enterocolitis have been operated upon during the acute stage of the disease. The authors explain the advantages and the disadvantages of the classical surgical procedures: laparotomy with exploration of the colon and resection of the necrotic segments followed by immediate reanastomosis or by enterostomy above the resected area. They recommend, however, a minimal laparotomy in the right lower quadrant with ileostomy on the terminal ileum without exploration of the colon or resection of the necrotic segments. The advantages of this technique are: minimal impairment of the general condition which increases the chances of survival; possibility to perform the resection later on when general and local conditions have improved; possibility for the lesions to heal spontaneously with short stenotic segments. Only 1 death among the 18 patients during the acute stage and none during the secondary procedures. In most of the cases, an economical resection could be performed with preservation of as much as possible of the normal bowel.

[Kaufmann syndrome or VACTERL association? Discussion of a differential diagnosis]. / Syndrome de Kaufman ou association VACTERL? Discussion d'un diagnostic différentiel.

The authors describe a dysmature female newborn, with multiple birth defects, who died soon after birth. At first polydactyly and hydrometrocolpos let think of a Kaufman syndrome, with autosomal recessive inheritance. But due to the presence of other malformations and since polydactyly is preaxial, the whole clinical and anatomical picture may be put into the frame of VACTERL association, mainly sporadic. Thus seemingly hydrometrocolpos and urogenital sinus have to be added, although rarely, to the other known defects of the VACTERL association.

A scoring system in predicting the risk of intestinal stricture in necrotizing enterocolitis.

Of 46 infants with a diagnosis of necrotizing enterocolitis (NEC) admitted to the neonatal intensive care unit over the period 1981-1985, 40 have been followed from 2 to 6 years after the acute episode. A contrast enema (CE) to look for intestinal strictures (IS) was performed either during the first months in surgically managed patients, or between 2 and 6 years in asymptomatic patients. Clinical, laboratory and radiology parameters collected during the 7 days following NEC were used to establish a score which was correlated with radiological data obtained after CE. Of the 40 infants, 17 developed symptomatic or asymptomatic IS and 16 of these 17 infants has a score greater than or equal to 7. Nineteen of the 23 patients without IS had a score less than 7. We conclude that the proposed score established on day 8 after onset of NEC helps to identify infants at higher risk of developing IS and for whom closer follow up appears necessary.