Challenges in Formulating Sunscreen Products.

Developing efficient sunscreen products with an acceptable sensory feel after application on skin, that meet current regulatory market and consumer requirements, is a major challenge, exacerbated by new restrictions limiting the use of certain ingredients previously considered crucial. This paper outlines a development strategy for -formulating sunscreens along a generic professional development pathway. Each galenic system will be different and must be customized. Development starts with benchmarking, followed by UVA/UVB filter platform selection and in silico calculation/optimization of photoprotection performance for the desired SPF, UVA-PF, and other requested endpoints. Next comes the selection of the emulsifier system and other key formulation ingredients, such as oil components, triplet quenchers, and antioxidants, with sensory, rheological, and film formation functions. Preliminary cost estimation is then performed to -complete the conceptual process before the start of the practical galenic development. The successful development of modern sunscreen products is based on -comprehensive expertise in chemistry, galenic methodology, regulation, and patenting, as well as specific -market and consumer requirements. The selection of the UV filters is the first key decision and constrains later choices. Other properties, such as water resistance and preservation or active ingredients, may need to be considered. The 4 basic requirements of efficacy, safety, registration, and patent freedom become checklist items to ensure that after development, a sunscreen product has a chance of success.

Injury thresholds after motor vehicle crash--important factors for patient triage and vehicle design.

INTRODUCTION: The Committee on Trauma recommends that older motor vehicle crash (MVC) victims or victims of crashes with significant vehicle intrusion of more than 12 in. be transferred to a trauma center since those older than 55 have an increased risk of death after injury. Yet, the precise injury thresholds as they relate to age, gender and velocity remain ill-defined. To maintain a low rate of under triage, reliable methods to identify patients at moderate injury risk are needed. We therefore characterized the likelihood of moderate to severe injury in MVC victims to determine the influence of age, gender and velocity. METHODS: An analysis of drivers from the National Automotive Sampling System (1993-2001) was performed. Weighted logistic regression models were developed to predict the probability of head, leg, and torso injuries as a function of vehicle speed, age, and gender while controlling for confounders. A 10% probability of injury threshold was set and differences in velocity, gender and age were identified in terms of reaching this probability of injury threshold. RESULTS: The analysis yielded 56,459 drivers which is equivalent to a population of 28,877,696 drivers nationwide. Restraint use, steering away prior to impact, breaking maneuver, gender, delta velocity, driver height and age were independent predictors of injury. Women had a higher velocity injury threshold than men for the 10% probability of injury cut-off to the torso or head which disappeared with increasing age. Conversely, men had a higher velocity injury threshold than women for the 10% probability of injury cut-off to the extremity which persisted even in older victims. CONCLUSIONS: Our data indicate that age and gender must be considered in addition to crash velocity when making triage decisions. Furthermore, Federal Motor Vehicle Safety Standards may need to be modified to address the increased risk of injury among older adults at lower velocities given the increasing number of elderly drivers in the US.

Short communication: Milk fat globule membrane as a potential delivery system for liposoluble nutrients.

A soft physical process was used to extract and purified bovine milk fat globule membrane (MFGM) fractions on a pilot scale. Oil-in-water emulsions enriched with alpha-tocopherol and lycopene were then prepared and stabilized with the extracted MFGM fraction and conventional milk protein concentrates (i.e., whey proteins, caseinate). A protocol of in vitro digestion was set up to evaluate the bioaccessibility of the tocopherol and lycopene in the different emulsions. Bioaccessibility was defined as the capacity of liposoluble compounds to be transferred into mixed micelles formed during the digestion process. Results showed that the accumulation of the tocopherol and lycopene into mixed micelles in MFGM-stabilized emulsions was around 2-fold greater than in emulsions stabilized with conventional milk proteins. This result confirms the potential use of MFGM-enriched ingredients as delivery systems of liposoluble nutrients in food formulations.

Viscosity of pharmacopeial multimolecular ointment vehicles and pharmaceutical availability of a model therapeutic agent.

Viscosity was tested of basic ointment vehicles such as: white petrolatum, yellow petrolatum, anhydrous lanolin and eucerin produced by different manufacturers. Ointment vehicles of definite type differ significantly in rheological parameters. In the same group of products, the experimentally determined viscosity value of some vehicles is two-fold (petrolatum, anhydrous lanolin) or even three-fold (eucerin) higher than that of others. On the basis of rheological tests, using Einstein-Smoluchowski equation (D = kT/ 6pireta), theoretical coefficient was calculated of a model therapeutic agent--salicylic acid diffusion (-log chi2(i) = 1,22) from the tested vehicles to the external compartment. The obtained results were related to the performed in vitro measurements of the rate of salicylic acid release from the above mentioned ointment vehicles to model acceptor fluid. High correlation was observed between theoretical values of diffusion coefficients calculated on the basis of viscosity measurements and tested experimentally pharmaceutical availability of salicylic acid. It was confirmed by describing this dependence with regression equations of high correlation coefficients (r > or = 0,9667). Marked disproportions between rheological parameters of the vehicles of definite type produced by individual manufacturers are the cause of differences in pharmaceutical availability of therapeutic agents contained in these vehicles.

Utility of historical vehicle-control data in the interpretation of the local lymph node assay.

The accepted approach to the interpretation of local lymph node assay (LLNA) data requires comparison of responses in the test groups with background activity found in concurrent vehicle-treated controls. However, of established value in the interpretation of toxicity test data is the use of historical control values that provide one criterion against which to judge the integrity of individual experiments. Specifically, the availability of robust and relevant historical control data permits examination of whether, in any individual experiment, control values fall within the expected range. With the most commonly used vehicle employed in the LLNA, acetone/olive oil (4 : 1) (v/v), the mean values, standard deviations and normal ranges are increasingly well established for a given laboratory, although there is some variation between laboratories, particularly with regard to expected ranges. Against this background, it is possible to identify (and, if appropriate, eliminate) a concurrent vehicle-control value that falls well outside the expected range. To explore critically the potential merits of this approach, one specific example is examined in detail.

[Active ingredients, pharmaceutic aids and efficacy of topical drugs]. / Wirkstoffe, Hilfsstoffe und Wirksamkeit von Externa-Fertigarzneimitteln.

In local therapy, in contrast to all other forms of therapy, the galenic vehicle or various so-called inactive ingredients can influence the efficacy of the preparations to a great extent. This means that when such drugs are licensed, i.e. when their efficacy and safety are investigated, the therapeutic effects of the total compound under clinical conditions should form the basis for judgement, and not the pharmacological profile of the active substance alone. Taking these point into consideration, the value of application in phases, vehicle tolerance and the therapeutic properties of inactive ingredients, as compared with active ingredients, are assessed in relation to the range of indications of drugs. In this connection, the efficacy of generic products and the declaration of so-called inactive ingredients are discussed.

[One year's experience with pilocarpin-ocusert in the therapy of glaucoma (author's transl)]. / Ein Jahr Erfahrungen mit Pilocarpin-Ocusert in der Glaukombehandlung

The authors report on their own treatment results with the drug carrier Ocusert (Federal Rep. of Germany: Chemie Grunenthal). Furthermore the effect on the IOP and the compatibility including the accomodative myopia is discussed. The effect on IOP was approximately equal to Pilocarpine 2% four times daily. The accommodation myopia was significanly less than using Pilocarpin drops. A short time after insertion the conjuntiva was irritated but the irritation faded within a short time.